<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/NCT03255902</url>
  </required_header>
  <id_info>
    <org_study_id>2016-154</org_study_id>
    <nct_id>NCT03255902</nct_id>
  </id_info>
  <brief_title>Family Routines - Healthy Families</brief_title>
  <official_title>Family Routine - Healthy Families</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>William Beaumont Hospitals</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the proposed study, Family Routines - Healthy Families, is to examine the&#xD;
      feasibility and acceptability of a parenting/family routine intervention program for parents&#xD;
      of young children, ages 2-5, with type 1 diabetes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention in Family Routines - Healthy Families contains an established and effective&#xD;
      parent skills training curriculum called &quot;The Incredible Years,&quot; uniquely integrated with a&#xD;
      newly developed family evening routine component e.g., family dinner time and evening&#xD;
      routine, to promote improved metabolic control. The investigator will assess outcomes during&#xD;
      and at one week post intervention. Outcome measures will include family routine, specifically&#xD;
      the time between the dinner and bedtime glucose check, parent bedtime decision making, and&#xD;
      child overnight glucose control. In addition, parental quality of life and receptiveness to&#xD;
      the intervention will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 24, 2016</start_date>
  <completion_date type="Actual">January 17, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>This feasibility study will be a mixed methods non-randomized trial to examine the feasibility of combining a parent skill training intervention with a family evening routine intervention. Evidence of feasibility will include attendance, activities completed, and interviews.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of Intervention on Evening Glucose Control.</measure>
    <time_frame>After 6 weeks of classes</time_frame>
    <description>Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value</measure>
    <time_frame>Pre intervention to 3 months post intervention</time_frame>
    <description>3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>Families attending parenting classes</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Families attended 6 parenting sessions, filled out daily glucose screens, &amp; questionnaires</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Parenting classes</intervention_name>
    <description>Parenting Classes:The Incredible Years curriculum</description>
    <arm_group_label>Families attending parenting classes</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Self identification as primary care giver of child that fits following criteria:&#xD;
&#xD;
               1. Age 2 - 5 years&#xD;
&#xD;
               2. Diagnosis of Type 1 diabetes&#xD;
&#xD;
               3. Most recent Hemoglobin A1c (HbA1c) &gt; 8.0&#xD;
&#xD;
               4. Child a patient of Pediatric Endocrinology, Beaumont Children's Hospital&#xD;
&#xD;
          2. English fluency&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cognitively impaired&#xD;
&#xD;
          2. Does not meet inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>5 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna Marvicsin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Children's Hospital</affiliation>
  </overall_official>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <results_first_submitted>July 9, 2018</results_first_submitted>
  <results_first_submitted_qc>May 29, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">July 26, 2019</results_first_posted>
  <last_update_submitted>May 29, 2019</last_update_submitted>
  <last_update_submitted_qc>May 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Donna Marvicsin</investigator_full_name>
    <investigator_title>Nurse Practitioner, Pediatric Endocrinology</investigator_title>
  </responsible_party>
  <keyword>Diabetes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <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>August 29, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/02/NCT03255902/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Families Attending Parenting Classes</title>
          <description>Families attended 6 parenting sessions, filled out daily glucose screens, &amp; questionnaires&#xD;
Parenting classes: Parenting Classes:The Incredible Years curriculum</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>7 parents enrolled with children between the ages of 2 to 5 years old, but 2 did not complete.</population>
      <group_list>
        <group group_id="B1">
          <title>Families Attending Parenting Classes</title>
          <description>Families attended 6 parenting sessions, filled out daily glucose screens, &amp; questionnaires&#xD;
Parenting classes: Parenting Classes:The Incredible Years curriculum</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Effect of Intervention on Evening Glucose Control.</title>
        <description>Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.</description>
        <time_frame>After 6 weeks of classes</time_frame>
        <population>2 participants did not complete study</population>
        <group_list>
          <group group_id="O1">
            <title>Families Attending Parenting Classes</title>
            <description>Families attended 6 parenting sessions, filled out daily glucose screens, &amp; questionnaires&#xD;
Parenting classes: Parenting Classes:The Incredible Years curriculum</description>
          </group>
        </group_list>
        <measure>
          <title>Effect of Intervention on Evening Glucose Control.</title>
          <description>Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.</description>
          <population>2 participants did not complete study</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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value</title>
        <description>3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.</description>
        <time_frame>Pre intervention to 3 months post intervention</time_frame>
        <population>2 participants did not complete study</population>
        <group_list>
          <group group_id="O1">
            <title>Families Attending Parenting Classes</title>
            <description>Families attended 6 parenting sessions, filled out daily glucose screens, &amp; questionnaires&#xD;
Parenting classes: Parenting Classes:The Incredible Years curriculum</description>
          </group>
        </group_list>
        <measure>
          <title>Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value</title>
          <description>3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.</description>
          <population>2 participants did not complete study</population>
          <units>percent of HbA1c</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" lower_limit="-1.1" upper_limit="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 weeks</time_frame>
      <desc>A questionnaire and survey was used to collect information for this study. Participants were carefully observed for any signs of anxiety or discomfort or any serious adverse events.</desc>
      <group_list>
        <group group_id="E1">
          <title>Families Attending Parenting Class</title>
          <description>Families attended 6 parenting sessions, filled out daily glucose screens, &amp; questionnaires.&#xD;
Parenting Classes: The Incredible Years curriculum</description>
        </group>
      </group_list>
      <serious_events>
        <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="7"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="7"/>
              </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="7"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Donna Marvicsin, Nurse Practitioner, Pediatric Endocrinology</name_or_title>
      <organization>William Beaumont Hospitals</organization>
      <phone>248-568-6932</phone>
      <email>donna.marvicsin@beaumont.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/NCT03255902
org study id: 2016-154
nct id: NCT03255902
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the proposed study, Family Routines - Healthy Families, is to examine the
      feasibility and acceptability of a parenting/family routine intervention program for parents
      of young children, ages 2-5, with type 1 diabetes.
The intervention in Family Routines - Healthy Families contains an established and effective
      parent skills training curriculum called "The Incredible Years," uniquely integrated with a
      newly developed family evening routine component e.g., family dinner time and evening
      routine, to promote improved metabolic control. The investigator will assess outcomes during
      and at one week post intervention. Outcome measures will include family routine, specifically
      the time between the dinner and bedtime glucose check, parent bedtime decision making, and
      child overnight glucose control. In addition, parental quality of life and receptiveness to
      the intervention will be assessed.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: This feasibility study will be a mixed methods non-randomized trial to examine the feasibility of combining a parent skill training intervention with a family evening routine intervention. Evidence of feasibility will include attendance, activities completed, and interviews.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Effect of Intervention on Evening Glucose Control.
time frame: After 6 weeks of classes
description: Number of families whose child achieved a decrease overnight between bedtime blood glucose level and morning fasting glucose level following intervention at 6 weeks.
measure: Difference Between Child's Pre-intervention and 3 Month Hemoglobin A1c Value
time frame: Pre intervention to 3 months post intervention
description: 3-month Hemoglobin A1c value subtracted from pre-intervention Hemoglobin A1c value. Positive numbers indicate an improvement in glucose control with intervention, and negative numbers indicate no improvement in glucose control with intervention.
arm group label: Families attending parenting classes
arm group type: Experimental
description: Families attended 6 parenting sessions, filled out daily glucose screens, & questionnaires
intervention type: Behavioral
intervention name: Parenting classes
description: Parenting Classes:The Incredible Years curriculum
arm group label: Families attending parenting classes
criteria: 
gender: All
minimum age: 2 Years
maximum age: 5 Years
healthy volunteers: No
last name: Donna Marvicsin, PhD
role: Principal Investigator
affiliation: William Beaumont Children's Hospital
responsible party type: Principal Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Donna Marvicsin
investigator title: Nurse Practitioner, Pediatric Endocrinology
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 