<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/NCT04423133</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2020000656</org_study_id>
    <nct_id>NCT04423133</nct_id>
  </id_info>
  <brief_title>Bilingual Family Literacy Program Pilot</brief_title>
  <official_title>Bilingual Family Literacy Program Pilot: Ready and Healthy for Kindergarten</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 will examine the feasibility of implementing a virtual bilingual health-focused&#xD;
      family literacy program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &quot;Ready and Healthy for Kindergarten&quot; is a bilingual family literacy program that uses&#xD;
      anticipatory guidance on important health routines to introduce critical language and&#xD;
      literacy skills to young Latino children entering Kindergarten and their families.&#xD;
&#xD;
      The objectives of this study are 1) To assess the feasibility of implementing the bilingual&#xD;
      family literacy program online via video conference by collecting information on family&#xD;
      attendance and participation, 2) To examine the acceptability of the program, and 3) To&#xD;
      explore preliminary effects of the program on the family health and language routines as well&#xD;
      as child language and literacy skill acquisition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2020</start_date>
  <completion_date type="Actual">September 4, 2020</completion_date>
  <primary_completion_date type="Actual">September 4, 2020</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of sessions attended by participants</measure>
    <time_frame>8 weeks</time_frame>
    <description>Data on the number of sessions attended by participants will be used to assess the feasibility of the online family literacy program.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the program</measure>
    <time_frame>8 weeks</time_frame>
    <description>Data on acceptability of the program will be collected via parent surveys</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>StimQ Reading Scale</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Reading activity will be measured using the StimQ Reading Scale. The StimQ is a structured interview. Individual items are summed and scores range from 0 to 19. Higher scores reflect higher reading activities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>StimQ Parental Verbal Responsivity Scale</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Parent verbal responsiveness will be measured using the StimQ Parental Verbal Responsivity Scale. The StimQ is a structured interview. Individual items are summed and scores range from 0 to 7. Higher scores reflect higher parent verbal responsiveness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Child Literacy Skills</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Investigator developed assessments of child alphabet knowledge and sight word recognition. Higher scores reflect higher literacy skills.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Family Health Routines Assessment</measure>
    <time_frame>Baseline, 8 weeks</time_frame>
    <description>Descriptive survey measuring family health routines and behaviors.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Language Development</condition>
  <condition>Literacy</condition>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Online Family Literacy Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Ready and Healthy for Kindergarten program is a bilingual family literacy program that uses anticipatory guidance on health routines (e.g., physical activity) to introduce language and literacy skills to children and their families delivered via an online video conference format.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Online Family Literacy Program</intervention_name>
    <description>Parent-child dyads will participate in 8 weekly online health-themed workshops that introduce language and literacy skills. Participants will also receive 2-3 text messages per week for the duration of the program and children's books.</description>
    <arm_group_label>Online Family Literacy Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preferred language either Spanish or bilingual (English and Spanish)&#xD;
&#xD;
          -  Parent or legal guardian of the child&#xD;
&#xD;
          -  Parent Age ≥ 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children not entering Kindergarten.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manuel E Jimenez, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers Biomedical Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Child Health Institute of NJ</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>September 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 25, 2020</last_update_submitted>
  <last_update_submitted_qc>September 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 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>Language development</keyword>
  <keyword>Health routines</keyword>
  <keyword>Literacy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04423133
org study id: Pro2020000656
nct id: NCT04423133
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the feasibility of implementing a virtual bilingual health-focused
      family literacy program.
"Ready and Healthy for Kindergarten" is a bilingual family literacy program that uses
      anticipatory guidance on important health routines to introduce critical language and
      literacy skills to young Latino children entering Kindergarten and their families.

      The objectives of this study are 1) To assess the feasibility of implementing the bilingual
      family literacy program online via video conference by collecting information on family
      attendance and participation, 2) To examine the acceptability of the program, and 3) To
      explore preliminary effects of the program on the family health and language routines as well
      as child language and literacy skill acquisition.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of sessions attended by participants
time frame: 8 weeks
description: Data on the number of sessions attended by participants will be used to assess the feasibility of the online family literacy program.
measure: Acceptability of the program
time frame: 8 weeks
description: Data on acceptability of the program will be collected via parent surveys
measure: StimQ Reading Scale
time frame: Baseline, 8 weeks
description: Reading activity will be measured using the StimQ Reading Scale. The StimQ is a structured interview. Individual items are summed and scores range from 0 to 19. Higher scores reflect higher reading activities.
measure: StimQ Parental Verbal Responsivity Scale
time frame: Baseline, 8 weeks
description: Parent verbal responsiveness will be measured using the StimQ Parental Verbal Responsivity Scale. The StimQ is a structured interview. Individual items are summed and scores range from 0 to 7. Higher scores reflect higher parent verbal responsiveness.
measure: Child Literacy Skills
time frame: Baseline, 8 weeks
description: Investigator developed assessments of child alphabet knowledge and sight word recognition. Higher scores reflect higher literacy skills.
measure: Family Health Routines Assessment
time frame: Baseline, 8 weeks
description: Descriptive survey measuring family health routines and behaviors.
arm group label: Online Family Literacy Program
arm group type: Experimental
description: The Ready and Healthy for Kindergarten program is a bilingual family literacy program that uses anticipatory guidance on health routines (e.g., physical activity) to introduce language and literacy skills to children and their families delivered via an online video conference format.
intervention type: Behavioral
intervention name: Online Family Literacy Program
description: Parent-child dyads will participate in 8 weekly online health-themed workshops that introduce language and literacy skills. Participants will also receive 2-3 text messages per week for the duration of the program and children's books.
arm group label: Online Family Literacy Program
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Manuel E Jimenez, MD, MS
role: Principal Investigator
affiliation: Rutgers Biomedical Health Sciences
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
sharing ipd: No