<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03797898</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000413</org_study_id>
    <secondary_id>5R01HD088586</secondary_id>
    <nct_id>NCT03797898</nct_id>
  </id_info>
  <brief_title>Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care</brief_title>
  <official_title>Well-Child Care Clinical Practice Redesign: A Parent Coach-Led Model of Care for Young Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based&#xD;
      approach to care using a health educator (&quot;Parent Coach&quot;) to provide the bulk of WCC&#xD;
      services, address specific needs faced by families in low-income communities, and decrease&#xD;
      reliance on the clinician as the primary provider of WCC services. The Parent Coach provides&#xD;
      anticipatory guidance, psychosocial and social needs screening/referral, and developmental&#xD;
      and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by&#xD;
      parent-focused pre-visit screening and visit prioritization, a brief, problem-focused&#xD;
      clinician encounter for a physical exam and any concerns that require a clinician's&#xD;
      attention, and an automated text message parent reminder and education service for periodic,&#xD;
      age-specific messages to reinforce key health-related information recommended by Bright&#xD;
      Futures national guidelines.&#xD;
&#xD;
      The investigators will conduct a cluster RCT of PARENT to determine its effects on quality,&#xD;
      utilization, and clinician efficiency, and its cost/cost-offset.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Well-Child Care (WCC) visits for child preventive care during the first three years of life&#xD;
      are critical because they may be the only opportunity before a child reaches preschool to&#xD;
      identify and address important social, developmental, behavioral, and health issues that&#xD;
      could have significant impact and long-lasting effects on children's lives as adults. Despite&#xD;
      its potential, multiple studies have demonstrated that pediatric providers fail to provide&#xD;
      all recommended preventive and developmental services at these visits and that most parents&#xD;
      leave the visit with unaddressed psychosocial, developmental, and behavioral concerns.&#xD;
      Further, these missed opportunities are more pronounced for children in low-income families.&#xD;
&#xD;
      A critical problem is that the structure of WCC in the U.S. cannot support the vast array of&#xD;
      WCC needs of families. Key structural problems include (a) reliance on clinicians&#xD;
      (pediatricians, family physicians, or nurse practitioners) for basic, routine WCC services,&#xD;
      (b) limitation to a 15-minute face-to-face clinician-directed WCC visit for the wide array of&#xD;
      education and guidance services in WCC, and (c) lack of a systematic, patient-driven method&#xD;
      for visit customization to meet families' needs. These structural problems contribute to the&#xD;
      wide variations in processes of care and preventive care outcomes, resulting in poorer&#xD;
      quality of WCC and perhaps worse health outcomes, particularly for children in low-income&#xD;
      communities.&#xD;
&#xD;
      To address the gaps in current WCC this study introduces a new model of care to meet the&#xD;
      needs of children in low-income communities: Parent-focused Redesign for Encounters, Newborns&#xD;
      to Toddlers (PARENT). PARENT is a team-based approach to care using a health educator&#xD;
      (&quot;Parent Coach&quot;) to provide the bulk of WCC services, address specific needs faced by&#xD;
      families in low-income communities, and decrease reliance on the clinician as the primary&#xD;
      provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial&#xD;
      screening/referral, and developmental and behavioral surveillance, screening, and guidance at&#xD;
      each WCC visit, and is supported by parent-focused pre-visit screening and visit&#xD;
      prioritization, a brief, problem-focused clinician encounter for a physical exam and any&#xD;
      concerns that require a clinician's attention, and an automated text message parent reminder&#xD;
      and education service for periodic, age-specific messages to reinforce key health-related&#xD;
      information recommended by Bright Futures national guidelines.&#xD;
&#xD;
      To assess the efficacy of PARENT, the investigators will conduct a cluster randomized&#xD;
      controlled trial (RCT). The study will be conducted in partnership with 10 clinics.&#xD;
&#xD;
      In preparation for the trial, investigators will use a Community Engagement &amp; Intervention&#xD;
      Implementation process that has been successful in previous studies to guide the intervention&#xD;
      adaptation process, Parent Coach training, practice workflow, and intervention implementation&#xD;
      in the practices. For the study trial, the investigators will conduct a cluster RCT of PARENT&#xD;
      to determine its effects on quality, utilization, and clinician efficiency, and its&#xD;
      cost/cost-offset. The project's community partners include two federally-qualified health&#xD;
      centers (FQHC). FQHC #1 has 4 clinics participating in the study and FQHC #2 has 6 clinics&#xD;
      participating in the study. The total number of clinics participating in the study is 10&#xD;
      clinics randomized at the clinic level to intervention or control condition. The intervention&#xD;
      clinics will implement PARENT for all well-visits through age 2 years at their clinical site,&#xD;
      and the control clinics will continue usual care (clinician directed well-visit). 1,000&#xD;
      families will be enrolled at infant age ≤12 months and remain in the study for a period of 12&#xD;
      months. Parents will complete a survey at baseline and at 6 and 12-months post enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Actual">July 14, 2022</completion_date>
  <primary_completion_date type="Actual">July 14, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.&#xD;
scale, 0-100, higher is better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Healthcare Utilization: Emergency Department Utilization</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>any emergency department care visit for the index child in past 12 months (parent report)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit</measure>
    <time_frame>Data not collected due to COVID Pandemic restrictions on in clinic observations.</time_frame>
    <description>time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization: Hospitalizations</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>any hospitalizations for index child in past 12 months by parent report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization: Well Child Care Visits Up to Date</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>up to date on well child care by clinic electronic medical record review at 12 months post enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiences of Care: Helpfulness of Care Assessment by Parent Report</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">937</enrollment>
  <condition>Preventive Health Services</condition>
  <condition>Health Promotion</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual care well child care</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Parent Coach</intervention_name>
    <description>The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent/legal guardian-Child dyad attending well child check-up visits for a 2-week to&#xD;
             12- month WCC visit.&#xD;
&#xD;
          -  Parent is English or Spanish proficient&#xD;
&#xD;
          -  For multiple gestations, one infant will be randomly selected as the index child.&#xD;
             Infants with special health care needs will not be excluded from the study, since&#xD;
             these children generally need the same recommended preventive care services.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  More than one child attending Well-Child Care&#xD;
&#xD;
          -  Legal guardian of child is under 18 years of age&#xD;
&#xD;
          -  Parents who are employed by one of the federally-qualified health centers (FQHCs)&#xD;
&#xD;
          -  Parents/legal guardian not planning to continue receiving well child care services at&#xD;
             this clinic for their child in the next 12 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tumaini R Coker, MD/MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Research Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Mimila NA, Chung PJ, Elliott MN, Bethell CD, Chacon S, Biely C, Contreras S, Chavis T, Bruno Y, Moss T, Coker TR. Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial. Acad Pediatr. 2017 Sep-Oct;17(7):747-754. doi: 10.1016/j.acap.2017.02.004. Epub 2017 Feb 14.</citation>
    <PMID>28232142</PMID>
  </reference>
  <reference>
    <citation>Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10.</citation>
    <PMID>26908675</PMID>
  </reference>
  <reference>
    <citation>Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c.</citation>
    <PMID>23457149</PMID>
  </reference>
  <reference>
    <citation>Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.</citation>
    <PMID>24936004</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <results_first_submitted>January 10, 2023</results_first_submitted>
  <results_first_submitted_qc>June 23, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 26, 2023</results_first_posted>
  <last_update_submitted>June 23, 2023</last_update_submitted>
  <last_update_submitted_qc>June 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Tumaini Coker</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 14, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03797898/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from two multi-site federally qualified health centers (FQHCs) in California and Washington State, with 6 and 4 participating practices each. The first participant was enrolled March 5, 2019 and the last participant was enrolled July 1, 2021. **PLEASE NOTE that there were not multiple phases to the trial. this study was a cluster RCT that did not have multiple phases to the trial.</recruitment_details>
      <pre_assignment_details>Of 937 enrolled participants, 914 remained enrolled and were eligible to complete 12-month follow-up.&#xD;
Participants are unique parent/child dyads. The parents were enrolled and each parent had an index child that they provided data on. This was the child for who they were coming to the clinic for a well child visit, and the child had to be 12 months of age or younger.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>Clinics assigned to the intervention arm will use the Parent Coach model for well child care visits, for children ages 0-2. Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Clinics assigned to control group use usual well child care. They do not have a parent coach as part of the visit.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="452">452 parent participants with a child ≤12 months arriving for a well child visit</participants>
                <participants group_id="P2" count="485">485 parent participants with a child ≤12 months arriving for a well child visit</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="378"/>
                <participants group_id="P2" count="407"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="78"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="69"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Became ineligible</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>participants are parent/child dyads. Each dyad includes 1 parent with 1 child. there is no overlap-- so that the number of parents is equal to the number of children in the study. each parent/child dyad is from a unique family. This is the overall number of participants (914) contributing baseline data. Not all participants answered every baseline question, so the number for each of the baseline measures does not match with the total participating.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>usual care well child care</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="438"/>
            <count group_id="B2" value="476"/>
            <count group_id="B3" value="914"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Child Age (months). Parents reported on age of child. We did not collect data on parent age</description>
          <population>911 participants responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="435"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.0" spread="4.0"/>
                    <measurement group_id="B2" value="4.7" spread="4.0"/>
                    <measurement group_id="B3" value="4.4" spread="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <description>Participant (parent/caregiver) relationship to child. Child sex/gender was not collected.</description>
          <population>911 respondents responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Mother</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="435"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="414"/>
                    <measurement group_id="B2" value="454"/>
                    <measurement group_id="B3" value="868"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Father</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="435"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grandmother</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="435"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>Parent race/ethnicity (child race/ethnicity not collected)</description>
          <population>911 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Latino</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="474"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="321"/>
                    <measurement group_id="B2" value="343"/>
                    <measurement group_id="B3" value="664"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Latino Black</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="474"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Latino Asian</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="474"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Latino White</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="474"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Latino Multi-Racial</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="474"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Latino Other</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="474"/>
                    <count group_id="B3" value="911"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Primary language spoken at home</title>
          <description>Parent reported parent primary language spoken at home</description>
          <population>913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="913"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>English</title>
                  <measurement_list>
                    <measurement group_id="B1" value="212"/>
                    <measurement group_id="B2" value="243"/>
                    <measurement group_id="B3" value="455"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Spanish</title>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="199"/>
                    <measurement group_id="B3" value="396"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respondent country of birth</title>
          <description>Parent reported parent country of birth</description>
          <population>912 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="436"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="912"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>United States</title>
                  <measurement_list>
                    <measurement group_id="B1" value="218"/>
                    <measurement group_id="B2" value="249"/>
                    <measurement group_id="B3" value="467"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Country other than U.S.</title>
                  <measurement_list>
                    <measurement group_id="B1" value="218"/>
                    <measurement group_id="B2" value="227"/>
                    <measurement group_id="B3" value="445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Respondent marital status</title>
          <description>Parent reported parent marital status</description>
          <population>913 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="913"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="164"/>
                    <measurement group_id="B2" value="181"/>
                    <measurement group_id="B3" value="345"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Living with a partner</title>
                  <measurement_list>
                    <measurement group_id="B1" value="165"/>
                    <measurement group_id="B2" value="189"/>
                    <measurement group_id="B3" value="354"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Separated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Single (never married &amp; currently not living with a partner)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of adults in the home</title>
          <population>913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="913"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>1 adult</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 adults</title>
                  <measurement_list>
                    <measurement group_id="B1" value="232"/>
                    <measurement group_id="B2" value="257"/>
                    <measurement group_id="B3" value="489"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 adults</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 or more adults</title>
                  <measurement_list>
                    <measurement group_id="B1" value="117"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="231"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of children that parent has</title>
          <population>913 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="437"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="913"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>1 child</title>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="169"/>
                    <measurement group_id="B3" value="313"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2 children</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="126"/>
                    <measurement group_id="B3" value="256"/>
                  </measurement_list>
                </category>
                <category>
                  <title>3 children</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="187"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4 or more children</title>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child health insurance</title>
          <description>Parent reported insurance type for enrolled child</description>
          <population>912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="436"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="912"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Medicaid (Medi-Cal/Apple Health)</title>
                  <measurement_list>
                    <measurement group_id="B1" value="405"/>
                    <measurement group_id="B2" value="450"/>
                    <measurement group_id="B3" value="855"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Private Insurance Plan</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Military</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Uninsured</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child chronic medical problems</title>
          <description>Parent report of enrolled child chronic medical problems</description>
          <population>912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="436"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="912"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Chronic medical problems</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No chronic medical problems</title>
                  <measurement_list>
                    <measurement group_id="B1" value="426"/>
                    <measurement group_id="B2" value="470"/>
                    <measurement group_id="B3" value="896"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Trouble paying for any household expenses</title>
          <description>Parent report of &quot;some&quot; or &quot;a lot&quot; of trouble paying for any household expenses in the past 12 months</description>
          <population>907 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="432"/>
                    <count group_id="B2" value="475"/>
                    <count group_id="B3" value="907"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Trouble paying for any household expenses in past 12 months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="289"/>
                    <measurement group_id="B3" value="527"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No trouble paying for any household expenses in past 12 months</title>
                  <measurement_list>
                    <measurement group_id="B1" value="194"/>
                    <measurement group_id="B2" value="186"/>
                    <measurement group_id="B3" value="380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Highest level of education completed</title>
          <description>Parent highest level of education</description>
          <population>912 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="436"/>
                    <count group_id="B2" value="476"/>
                    <count group_id="B3" value="912"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Less than high school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="111"/>
                    <measurement group_id="B2" value="120"/>
                    <measurement group_id="B3" value="231"/>
                  </measurement_list>
                </category>
                <category>
                  <title>High school graduate or GED</title>
                  <measurement_list>
                    <measurement group_id="B1" value="159"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="325"/>
                  </measurement_list>
                </category>
                <category>
                  <title>2-Year college or some college</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="279"/>
                  </measurement_list>
                </category>
                <category>
                  <title>4-Year college degree or greater</title>
                  <measurement_list>
                    <measurement group_id="B1" value="39"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Household Annual Income</title>
          <description>Parent reported household annual income</description>
          <population>768 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="370"/>
                    <count group_id="B2" value="398"/>
                    <count group_id="B3" value="768"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt; $29,999 per year</title>
                  <measurement_list>
                    <measurement group_id="B1" value="246"/>
                    <measurement group_id="B2" value="236"/>
                    <measurement group_id="B3" value="482"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$30,000 to $49,999 per year</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$50,000 to $69,999 per year</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>$70,000 or more</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child's current overall health</title>
          <description>Parent reported child's current overall health</description>
          <population>908 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="433"/>
                    <count group_id="B2" value="475"/>
                    <count group_id="B3" value="908"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Excellent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="293"/>
                    <measurement group_id="B2" value="325"/>
                    <measurement group_id="B3" value="618"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very good</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="194"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Good</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fair/poor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Mental Health</title>
          <description>PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Mental Health was calculated by summing two 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 25.8-64.6. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals</description>
          <population>906 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>T-Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="432"/>
                    <count group_id="B2" value="474"/>
                    <count group_id="B3" value="906"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.7" spread="8.5"/>
                    <measurement group_id="B2" value="53.9" spread="8.2"/>
                    <measurement group_id="B3" value="54.3" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS (Patient-Reported Outcomes Measurement Information System) 2-item Global Physical Health</title>
          <description>PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Physical Health was calculated by summing 2 5-point Likert scale questions for a total possible of 2-10 (9 values), then converting those sums to corresponding PROMIS T-scores, for 9 T-score values ranging from 23.4-63.3. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals</description>
          <population>907 respondents of 914 responded to this item.Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>T-Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="432"/>
                    <count group_id="B2" value="475"/>
                    <count group_id="B3" value="907"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.1" spread="8.4"/>
                    <measurement group_id="B2" value="50.6" spread="7.9"/>
                    <measurement group_id="B3" value="50.9" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PROMIS (Patient-Reported Outcomes Measurement Information System) 4-item Emotional Support Score</title>
          <description>PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. PROMIS Emotional Support was calculated by summing 4 5-point Likert scale questions for a total possible of 4-20 (17 values), then converting those sums to corresponding PROMIS T-scores, for T-score values ranging from 25.7-62.0. Higher scores represent better outcomes. https://staging.healthmeasures.net/images/PROMIS/manuals</description>
          <population>905 respondents of 914 responded to this item. Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>T-Score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="430"/>
                    <count group_id="B2" value="475"/>
                    <count group_id="B3" value="905"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57.6" spread="7.0"/>
                    <measurement group_id="B2" value="57.2" spread="7.6"/>
                    <measurement group_id="B3" value="57.4" spread="7.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits</title>
        <description>Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.&#xD;
scale, 0-100, higher is better</description>
        <time_frame>12 months post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care well child care</description>
          </group>
        </group_list>
        <measure>
          <title>Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits</title>
          <description>Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.&#xD;
scale, 0-100, higher is better</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="375"/>
                <count group_id="O2" value="407"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.9" spread="23.4"/>
                    <measurement group_id="O2" value="63.3" spread="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Healthcare Utilization: Emergency Department Utilization</title>
        <description>any emergency department care visit for the index child in past 12 months (parent report)</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>all participants completing 12 month survey</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care well child care</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Utilization: Emergency Department Utilization</title>
          <description>any emergency department care visit for the index child in past 12 months (parent report)</description>
          <population>all participants completing 12 month survey</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="376"/>
                <count group_id="O2" value="407"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="140"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit</title>
        <description>time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations.</description>
        <time_frame>Data not collected due to COVID Pandemic restrictions on in clinic observations.</time_frame>
        <population>Data were not collected due to COVID 19 pandemic restrictions on in clinic observations</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Clinics assigned to the intervention arm will use the Parent Coach model for well child care visits, for children ages 0-2. Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Clinics assigned to control group use usual well child care. They do not have a parent coach as part of the visit.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit</title>
          <description>time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations.</description>
          <population>Data were not collected due to COVID 19 pandemic restrictions on in clinic observations</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits</title>
        <description>Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>all participants completing 12 month survey</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care well child care</description>
          </group>
        </group_list>
        <measure>
          <title>Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits</title>
          <description>Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items</description>
          <population>all participants completing 12 month survey</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="378"/>
                <count group_id="O2" value="407"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="253"/>
                    <measurement group_id="O2" value="203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.</title>
        <description>Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed.</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care well child care</description>
          </group>
        </group_list>
        <measure>
          <title>Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.</title>
          <description>Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed.</description>
          <population>Number analyzed differs from overall because of missing data (participant did not respond to item in question)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="378"/>
                <count group_id="O2" value="407"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Behavioral Concerns Elicited &amp; Addressed</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="342"/>
                    <count group_id="O2" value="356"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="305"/>
                    <measurement group_id="O2" value="292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Developmental Screening</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="363"/>
                    <count group_id="O2" value="394"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="310"/>
                    <measurement group_id="O2" value="332"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Utilization: Hospitalizations</title>
        <description>any hospitalizations for index child in past 12 months by parent report</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>all participants completing 12 month survey</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care well child care</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Utilization: Hospitalizations</title>
          <description>any hospitalizations for index child in past 12 months by parent report</description>
          <population>all participants completing 12 month survey</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="376"/>
                <count group_id="O2" value="406"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healthcare Utilization: Well Child Care Visits Up to Date</title>
        <description>up to date on well child care by clinic electronic medical record review at 12 months post enrollment</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>all enrolled participants who remained eligible, and consented to chart review by the 12-month post intervention assessment</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care well child care</description>
          </group>
        </group_list>
        <measure>
          <title>Healthcare Utilization: Well Child Care Visits Up to Date</title>
          <description>up to date on well child care by clinic electronic medical record review at 12 months post enrollment</description>
          <population>all enrolled participants who remained eligible, and consented to chart review by the 12-month post intervention assessment</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="419"/>
                <count group_id="O2" value="465"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="309"/>
                    <measurement group_id="O2" value="295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Experiences of Care: Helpfulness of Care Assessment by Parent Report</title>
        <description>parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>all participants completing 12 month survey</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care well child care</description>
          </group>
        </group_list>
        <measure>
          <title>Experiences of Care: Helpfulness of Care Assessment by Parent Report</title>
          <description>parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better</description>
          <population>all participants completing 12 month survey</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="378"/>
                <count group_id="O2" value="407"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.8" spread="25.2"/>
                    <measurement group_id="O2" value="69.8" spread="30.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report</title>
        <description>receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>all participants completing 12 month survey</population>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>usual care well child care</description>
          </group>
        </group_list>
        <measure>
          <title>Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report</title>
          <description>receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better</description>
          <population>all participants completing 12 month survey</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="378"/>
                <count group_id="O2" value="407"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.0" spread="22.5"/>
                    <measurement group_id="O2" value="85.5" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>As there were no risk of harm to participant dyads, we did not conduct a systematic approach to collecting data on harms. However, if in the course of the 12-month data collection, we gained information on participant harm to either the parent or child of the dyad, we report those as &quot;adverse events&quot;. The only such information we received was on one parent of the parent/child dyads enrolled, and this event (parent death) is reported both in the serious adverse event and in all cause mortality.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).&#xD;
Parent Coach: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>usual care well child care</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="452"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="485"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="452"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="485"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>death</sub_title>
                <description>the parent enrolled in the study passed away during the study period.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="452"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="485"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="452"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="485"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Tumaini R. Coker, MD, MBA</name_or_title>
      <organization>Seattle Children's</organization>
      <phone>206-884-0559</phone>
      <email>Tumaini.Coker@seattlechildrens.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03797898
org study id: STUDY00000413
secondary id: 5R01HD088586
nct id: NCT03797898
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Parent-focused Redesign for Encounters, Newborns to Toddlers (PARENT) is a team-based
      approach to care using a health educator ("Parent Coach") to provide the bulk of WCC
      services, address specific needs faced by families in low-income communities, and decrease
      reliance on the clinician as the primary provider of WCC services. The Parent Coach provides
      anticipatory guidance, psychosocial and social needs screening/referral, and developmental
      and behavioral surveillance, screening, and guidance at each WCC visit, and is supported by
      parent-focused pre-visit screening and visit prioritization, a brief, problem-focused
      clinician encounter for a physical exam and any concerns that require a clinician's
      attention, and an automated text message parent reminder and education service for periodic,
      age-specific messages to reinforce key health-related information recommended by Bright
      Futures national guidelines.

      The investigators will conduct a cluster RCT of PARENT to determine its effects on quality,
      utilization, and clinician efficiency, and its cost/cost-offset.
Well-Child Care (WCC) visits for child preventive care during the first three years of life
      are critical because they may be the only opportunity before a child reaches preschool to
      identify and address important social, developmental, behavioral, and health issues that
      could have significant impact and long-lasting effects on children's lives as adults. Despite
      its potential, multiple studies have demonstrated that pediatric providers fail to provide
      all recommended preventive and developmental services at these visits and that most parents
      leave the visit with unaddressed psychosocial, developmental, and behavioral concerns.
      Further, these missed opportunities are more pronounced for children in low-income families.

      A critical problem is that the structure of WCC in the U.S. cannot support the vast array of
      WCC needs of families. Key structural problems include (a) reliance on clinicians
      (pediatricians, family physicians, or nurse practitioners) for basic, routine WCC services,
      (b) limitation to a 15-minute face-to-face clinician-directed WCC visit for the wide array of
      education and guidance services in WCC, and (c) lack of a systematic, patient-driven method
      for visit customization to meet families' needs. These structural problems contribute to the
      wide variations in processes of care and preventive care outcomes, resulting in poorer
      quality of WCC and perhaps worse health outcomes, particularly for children in low-income
      communities.

      To address the gaps in current WCC this study introduces a new model of care to meet the
      needs of children in low-income communities: Parent-focused Redesign for Encounters, Newborns
      to Toddlers (PARENT). PARENT is a team-based approach to care using a health educator
      ("Parent Coach") to provide the bulk of WCC services, address specific needs faced by
      families in low-income communities, and decrease reliance on the clinician as the primary
      provider of WCC services. The Parent Coach provides anticipatory guidance, psychosocial
      screening/referral, and developmental and behavioral surveillance, screening, and guidance at
      each WCC visit, and is supported by parent-focused pre-visit screening and visit
      prioritization, a brief, problem-focused clinician encounter for a physical exam and any
      concerns that require a clinician's attention, and an automated text message parent reminder
      and education service for periodic, age-specific messages to reinforce key health-related
      information recommended by Bright Futures national guidelines.

      To assess the efficacy of PARENT, the investigators will conduct a cluster randomized
      controlled trial (RCT). The study will be conducted in partnership with 10 clinics.

      In preparation for the trial, investigators will use a Community Engagement & Intervention
      Implementation process that has been successful in previous studies to guide the intervention
      adaptation process, Parent Coach training, practice workflow, and intervention implementation
      in the practices. For the study trial, the investigators will conduct a cluster RCT of PARENT
      to determine its effects on quality, utilization, and clinician efficiency, and its
      cost/cost-offset. The project's community partners include two federally-qualified health
      centers (FQHC). FQHC #1 has 4 clinics participating in the study and FQHC #2 has 6 clinics
      participating in the study. The total number of clinics participating in the study is 10
      clinics randomized at the clinic level to intervention or control condition. The intervention
      clinics will implement PARENT for all well-visits through age 2 years at their clinical site,
      and the control clinics will continue usual care (clinician directed well-visit). 1,000
      families will be enrolled at infant age ≤12 months and remain in the study for a period of 12
      months. Parents will complete a survey at baseline and at 6 and 12-months post enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Receipt of Preventive Care Services: Anticipatory Guidance Topics Received by Parent Report at Well Visits
time frame: 12 months post enrollment
description: Using anticipatory guidance items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended anticipatory guidance topics.
scale, 0-100, higher is better
measure: Healthcare Utilization: Emergency Department Utilization
time frame: 12 months post enrollment
description: any emergency department care visit for the index child in past 12 months (parent report)
measure: Clinician Time With Parent During the Well-Child Care (WCC) Visit, From Observations of Well Child Care Visit
time frame: Data not collected due to COVID Pandemic restrictions on in clinic observations.
description: time spent in parent-provider visit during the well child care visit. these data were not collected for trial participants at baseline. At follow-up, we did not collect data due to pandemic restrictions in doing observations.
measure: Receipt of Preventive Care Services: Psychosocial Screening Received by Parent Report at Well Visits
time frame: 12 months post enrollment
description: Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents received psychosocial assessment on all 7 items
measure: Receipt of Preventive Care Services: Developmental Concerns Addressed and Screening Received by Parent Report at Well Visits.
time frame: 12 months post enrollment
description: Using items adapted from the Promoting Healthy Development Survey, the investigators will assess whether parents receive the recommended developmental screening and were asked if they had their developmental concerns addressed.
measure: Healthcare Utilization: Hospitalizations
time frame: 12 months post enrollment
description: any hospitalizations for index child in past 12 months by parent report
measure: Healthcare Utilization: Well Child Care Visits Up to Date
time frame: 12 months post enrollment
description: up to date on well child care by clinic electronic medical record review at 12 months post enrollment
measure: Experiences of Care: Helpfulness of Care Assessment by Parent Report
time frame: 12 months post enrollment
description: parent reported helpfulness of care, using items adapted from Promoting Healthy Development Survey scale is 0-100, higher is better
measure: Experiences of Care: Family Centeredness of Care- Whether it Was Received by Parent Report
time frame: 12 months post enrollment
description: receipt of family centeredness of care using items adapted from National Survey of Children's Health scale 0-100, higher is better
arm group label: Intervention
arm group type: Experimental
description: Parents will meet with a Parent Coach during child's routine well visits, and have access to the parent coach between visits for additional follow up and concerns, and have access to a preventive care text messaging services (Healthy Txt).
arm group label: Control
arm group type: No Intervention
description: usual care well child care
intervention type: Other
intervention name: Parent Coach
description: The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Tumaini R Coker, MD/MBA
role: Principal Investigator
affiliation: Seattle Children's
facility: 
facility: 
country: United States
citation: Mimila NA, Chung PJ, Elliott MN, Bethell CD, Chacon S, Biely C, Contreras S, Chavis T, Bruno Y, Moss T, Coker TR. Well-Child Care Redesign: A Mixed Methods Analysis of Parent Experiences in the PARENT Trial. Acad Pediatr. 2017 Sep-Oct;17(7):747-754. doi: 10.1016/j.acap.2017.02.004. Epub 2017 Feb 14.
PMID: 28232142
citation: Coker TR, Chacon S, Elliott MN, Bruno Y, Chavis T, Biely C, Bethell CD, Contreras S, Mimila NA, Mercado J, Chung PJ. A Parent Coach Model for Well-Child Care Among Low-Income Children: A Randomized Controlled Trial. Pediatrics. 2016 Mar;137(3):e20153013. doi: 10.1542/peds.2015-3013. Epub 2016 Feb 10.
PMID: 26908675
citation: Coker TR, Windon A, Moreno C, Schuster MA, Chung PJ. Well-child care clinical practice redesign for young children: a systematic review of strategies and tools. Pediatrics. 2013 Mar;131 Suppl 1(Suppl 1):S5-25. doi: 10.1542/peds.2012-1427c.
PMID: 23457149
citation: Coker TR, Moreno C, Shekelle PG, Schuster MA, Chung PJ. Well-child care clinical practice redesign for serving low-income children. Pediatrics. 2014 Jul;134(1):e229-39. doi: 10.1542/peds.2013-3775. Epub 2014 Jun 16.
PMID: 24936004
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Tumaini Coker
investigator title: Associate Professor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 