<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/NCT03281356</url>
  </required_header>
  <id_info>
    <org_study_id>Pro20170000402</org_study_id>
    <nct_id>NCT03281356</nct_id>
  </id_info>
  <brief_title>Text Messaging Pilot Study</brief_title>
  <official_title>Text Messaging Pilot Study to Encourage Shared Reading Among a Sample of Urban Parents.</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 pilot study aims to assess the acceptability, feasibility, and preliminary effectiveness&#xD;
      of text messages designed to encourage shared reading among urban parents. We hypothesize&#xD;
      that parents will report reading more often to their children after receiving the text&#xD;
      messages.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm, pilot study. The participants enrolled will receive two text messages&#xD;
      per week for a 4 week period (a total of 8 messages). At the end of the study period we will&#xD;
      assess change in number of reading occurrences using a validated measure. Parents will also&#xD;
      complete a brief acceptability survey.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 9, 2017</start_date>
  <completion_date type="Actual">June 13, 2017</completion_date>
  <primary_completion_date type="Actual">June 13, 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability Survey</measure>
    <time_frame>Visit 2 (1 month)</time_frame>
    <description>Three questions on the participants feedback on the program.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stim Q Survey</measure>
    <time_frame>Visit 2 (1 month)</time_frame>
    <description>The StimQ is a parent reported measure of the cognitive home environment</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Literacy</condition>
  <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>Participants will receive a total of 8 text messages during a 4 week period.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Preferred language either English or Spanish,&#xD;
&#xD;
          2. Parent or legal guardian,&#xD;
&#xD;
          3. Age ≥ 18,&#xD;
&#xD;
          4. Willing to accept text messages&#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>Rutgers Robert Wood Johnson Medical School</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 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</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>Pilot Study</keyword>
  <keyword>Early childhood development</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/NCT03281356
org study id: Pro20170000402
nct id: NCT03281356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This pilot study aims to assess the acceptability, feasibility, and preliminary effectiveness
      of text messages designed to encourage shared reading among urban parents. We hypothesize
      that parents will report reading more often to their children after receiving the text
      messages.
This is a single arm, pilot study. The participants enrolled will receive two text messages
      per week for a 4 week period (a total of 8 messages). At the end of the study period we will
      assess change in number of reading occurrences using a validated measure. Parents will also
      complete a brief acceptability survey.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Acceptability Survey
time frame: Visit 2 (1 month)
description: Three questions on the participants feedback on the program.
measure: Stim Q Survey
time frame: Visit 2 (1 month)
description: The StimQ is a parent reported measure of the cognitive home environment
arm group label: Intervention Group
arm group type: Experimental
intervention type: Behavioral
intervention name: Intervention Group
description: Participants will receive a total of 8 text messages during a 4 week period.
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