<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/NCT03242850</url>
  </required_header>
  <id_info>
    <org_study_id>Pro20170000878</org_study_id>
    <secondary_id>73308</secondary_id>
    <nct_id>NCT03242850</nct_id>
  </id_info>
  <brief_title>Assuring Patient-centered Literacy Promotion for Underserved Children Study</brief_title>
  <acronym>APLUS</acronym>
  <official_title>Assuring Patient-centered Literacy Promotion for Underserved Children to Promote School Readiness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Robert Wood Johnson Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</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>
      This study tests whether an enhanced primary cared based literacy promotion intervention&#xD;
      consisting of a video and text message will increase shared reading occurrences between&#xD;
      parents and children compared to the standard version.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial aimed at assessing the effectiveness of an enhanced&#xD;
      intervention consisting of a video and a series of text messages in promoting shared reading&#xD;
      between parents and children. Participants will be randomized to one of two study arms (1)&#xD;
      the enhanced intervention consisting of a video in the waiting room, standard guidance on&#xD;
      shared reading, and a series of text messages (2) regular care which includes standard&#xD;
      guidance on shared reading. The primary outcome will be shared reading occurrences. Secondary&#xD;
      outcomes will include receipt of intervention, measure of the cognitive home environment,&#xD;
      developmental screening results, and measure of parent reading beliefs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2018</start_date>
  <completion_date type="Actual">August 24, 2019</completion_date>
  <primary_completion_date type="Actual">August 24, 2019</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reading Recall</measure>
    <time_frame>Visit 2 (approx. 6 months)</time_frame>
    <description>Parents will report reading occurrences in a 1 week period including a 24-hour recall.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survey of Wellbeing of Young Children Milestones</measure>
    <time_frame>Visit 2 (approx. 6 months)</time_frame>
    <description>Parents will complete the SWYC milestones, a validated, 10 item parent report, developmental screening tool.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>StimQ2 Read Scale / Parental Verbal Responsivity Scale</measure>
    <time_frame>Visit 2 (approx. 6 months)</time_frame>
    <description>The StimQ2 is a parent reported measure of the cognitive home environment for children age 5 months to 6 years that assesses 4 domains: (1) Availability of Learning Materials (2) Reading (3) Parent Involvement in Developmental Advancement (4) Parental Verbal Responsiveness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Reading Beliefs Inventory</measure>
    <time_frame>Visit 2 (approx. 6 months)</time_frame>
    <description>Measure of parent reading beliefs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Receipt of intervention</measure>
    <time_frame>Visit 2 (approx. 6 months)</time_frame>
    <description>Parent report of receipt of guidance on shared reading</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Literacy</condition>
  <arm_group>
    <arm_group_label>Regular care group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will receive regular care including standard guidance on shared reading. Participants in this arm will not view the video at the time of enrollment nor will they receive the text messages throughout the 6 months of the randomized controlled trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Group</intervention_name>
    <description>This group will view a video on shared reading upon enrollment, receive standard guidance on shared reading, and receive a series of text messages for a period of 6 months.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. primary caregiver of a child age 6-15 months,&#xD;
&#xD;
          2. primary language English or Spanish,&#xD;
&#xD;
          3. cell phone ownership,&#xD;
&#xD;
          4. age ≥18 years,&#xD;
&#xD;
          5. willing to receive text messages, and&#xD;
&#xD;
          6. willing to accept randomization&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals unable to provide consent&#xD;
&#xD;
          2. Individuals who do not meet inclusion criteria&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eric B. Chandler Health Center</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>February 14, 2020</last_update_submitted>
  <last_update_submitted_qc>February 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Manuel E. Jimenez, MD, MS</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>Reading</keyword>
  <keyword>Text Messages</keyword>
  <keyword>Video</keyword>
  <keyword>Cognitive Development</keyword>
  <keyword>Child Development</keyword>
  <keyword>Infants</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03242850
org study id: Pro20170000878
secondary id: 73308
nct id: NCT03242850
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study tests whether an enhanced primary cared based literacy promotion intervention
      consisting of a video and text message will increase shared reading occurrences between
      parents and children compared to the standard version.
This is a randomized controlled trial aimed at assessing the effectiveness of an enhanced
      intervention consisting of a video and a series of text messages in promoting shared reading
      between parents and children. Participants will be randomized to one of two study arms (1)
      the enhanced intervention consisting of a video in the waiting room, standard guidance on
      shared reading, and a series of text messages (2) regular care which includes standard
      guidance on shared reading. The primary outcome will be shared reading occurrences. Secondary
      outcomes will include receipt of intervention, measure of the cognitive home environment,
      developmental screening results, and measure of parent reading beliefs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Reading Recall
time frame: Visit 2 (approx. 6 months)
description: Parents will report reading occurrences in a 1 week period including a 24-hour recall.
measure: Survey of Wellbeing of Young Children Milestones
time frame: Visit 2 (approx. 6 months)
description: Parents will complete the SWYC milestones, a validated, 10 item parent report, developmental screening tool.
measure: StimQ2 Read Scale / Parental Verbal Responsivity Scale
time frame: Visit 2 (approx. 6 months)
description: The StimQ2 is a parent reported measure of the cognitive home environment for children age 5 months to 6 years that assesses 4 domains: (1) Availability of Learning Materials (2) Reading (3) Parent Involvement in Developmental Advancement (4) Parental Verbal Responsiveness.
measure: Parental Reading Beliefs Inventory
time frame: Visit 2 (approx. 6 months)
description: Measure of parent reading beliefs
measure: Receipt of intervention
time frame: Visit 2 (approx. 6 months)
description: Parent report of receipt of guidance on shared reading
arm group label: Regular care group
arm group type: No Intervention
description: This group will receive regular care including standard guidance on shared reading. Participants in this arm will not view the video at the time of enrollment nor will they receive the text messages throughout the 6 months of the randomized controlled trial.
arm group label: Intervention group
arm group type: Experimental
intervention type: Behavioral
intervention name: Intervention Group
description: This group will view a video on shared reading upon enrollment, receive standard guidance on shared reading, and receive a series of text messages for a period of 6 months.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Manuel E. Jimenez, MD, MS
investigator title: Assistant professor