<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/NCT03026179</url>
  </required_header>
  <id_info>
    <org_study_id>PN_CultSen</org_study_id>
    <nct_id>NCT03026179</nct_id>
  </id_info>
  <brief_title>Education of Parents About Discipline in a Way That is Culturally Sensitive</brief_title>
  <official_title>Education of Parents About Discipline in a Way That is Culturally Sensitive</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if a brief primary care intervention can educate under-resourced and minority&#xD;
      parents about discipline in a way that is culturally sensitive.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cultural Sensitivity</measure>
    <time_frame>baseline</time_frame>
    <description>Parents were asked to view 5-10 minutes of an educational program. Following the clinic visit, parents were asked several questions about whether the program was culturally sensitive.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in discipline questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>Parents were asked if they planned to make any changes in how they discipline at home.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Spanking questionnaire</measure>
    <time_frame>baseline</time_frame>
    <description>If parent stated that they planned to use less spanking at home, a follow up question was asked about what caused them to decide to spank less.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Violence</condition>
  <condition>Parenting</condition>
  <arm_group>
    <arm_group_label>Intervention parents</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Parents were asked to view 5-10 minutes of a program designed to educate about discipline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Play Nicely</intervention_name>
    <description>Play Nicely is a multimedia program that teaches parents about appropriate methods to discipline.</description>
    <arm_group_label>Intervention parents</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents presenting with their children to a pediatric clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Seth Scholer, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University</affiliation>
  </overall_official>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>December 9, 2015</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>November 7, 2019</last_update_submitted>
  <last_update_submitted_qc>November 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University</investigator_affiliation>
    <investigator_full_name>Seth Scholer</investigator_full_name>
    <investigator_title>Associate Professor of Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT03026179
org study id: PN_CultSen
nct id: NCT03026179
lead sponsor: 
has dmc: No
To determine if a brief primary care intervention can educate under-resourced and minority
      parents about discipline in a way that is culturally sensitive.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Cultural Sensitivity
time frame: baseline
description: Parents were asked to view 5-10 minutes of an educational program. Following the clinic visit, parents were asked several questions about whether the program was culturally sensitive.
measure: Changes in discipline questionnaire
time frame: baseline
description: Parents were asked if they planned to make any changes in how they discipline at home.
measure: Spanking questionnaire
time frame: baseline
description: If parent stated that they planned to use less spanking at home, a follow up question was asked about what caused them to decide to spank less.
arm group label: Intervention parents
arm group type: Other
description: Parents were asked to view 5-10 minutes of a program designed to educate about discipline.
intervention type: Behavioral
intervention name: Play Nicely
description: Play Nicely is a multimedia program that teaches parents about appropriate methods to discipline.
arm group label: Intervention parents
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Seth Scholer, MD, MPH
role: Principal Investigator
affiliation: Vanderbilt University
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University
investigator full name: Seth Scholer
investigator title: Associate Professor of Pediatrics
mesh term: Hypersensitivity