<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/NCT02258633</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00026025</org_study_id>
    <nct_id>NCT02258633</nct_id>
  </id_info>
  <brief_title>The Seatbelt Intervention Study</brief_title>
  <official_title>A Brief Tailored Family-centered Seatbelt Intervention for Hospitalized Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study will use a randomized controlled design testing the effectiveness of the following&#xD;
      intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The&#xD;
      study will identify children ages 2-14 at a pediatric trauma center. Children and their&#xD;
      parents who agree to participate in the study will then complete a screening survey to&#xD;
      identify part time seatbelt use. Those who screen positive will complete a more detailed&#xD;
      baseline survey and then be randomized to one of two study conditions. At one month, a follow&#xD;
      up assessment by telephone will be completed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <primary_completion_date type="Actual">February 2010</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>Seat belt use</measure>
    <time_frame>1 month</time_frame>
    <description>Follow up telephone assessment on full time seat belt use by parent and child</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seat belt knowledge</measure>
    <time_frame>1 month</time_frame>
    <description>Follow up telephone assessment on level of knowledge of seat belt use and risk factors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attitudes</measure>
    <time_frame>1 month</time_frame>
    <description>Follow up telephone assessment of positive attitude, motivation, and self-efficacy regarding safety restraint use.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>High Risk Population of Part-time Seatbelt Users</condition>
  <arm_group>
    <arm_group_label>Intervener Brief Intervention (IBI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects and parents will complete a Brief Motivational Interview (BMI) incorporating personalized feedback, discussion of choices and changes, and therapist led intervention message relating behavioral change and future goals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects and parents will receive standard trauma care, plus complete brief questionnaires and receive general safety information.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interactive interview and tailored family centered seatbelt safety intervention</intervention_name>
    <arm_group_label>Intervener Brief Intervention (IBI)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children ages 7-14 and their parent or guardian, at a pediatric trauma center&#xD;
&#xD;
          -  Child admitted to hospital with diagnosis of injury other than sexual assault and&#xD;
             suicide&#xD;
&#xD;
          -  Identify as part time seat belt users&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>October 6, 2014</last_update_submitted>
  <last_update_submitted_qc>October 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Peter Ehrlich</investigator_full_name>
    <investigator_title>Co-Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT02258633
org study id: HUM00026025
nct id: NCT02258633
lead sponsor: 
has dmc: No
The study will use a randomized controlled design testing the effectiveness of the following
      intervention: (i) intervener brief intervention (IBI) vs. (ii) Enhanced usual care (EUC). The
      study will identify children ages 2-14 at a pediatric trauma center. Children and their
      parents who agree to participate in the study will then complete a screening survey to
      identify part time seatbelt use. Those who screen positive will complete a more detailed
      baseline survey and then be randomized to one of two study conditions. At one month, a follow
      up assessment by telephone will be completed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Seat belt use
time frame: 1 month
description: Follow up telephone assessment on full time seat belt use by parent and child
measure: Seat belt knowledge
time frame: 1 month
description: Follow up telephone assessment on level of knowledge of seat belt use and risk factors
measure: Attitudes
time frame: 1 month
description: Follow up telephone assessment of positive attitude, motivation, and self-efficacy regarding safety restraint use.
arm group label: Intervener Brief Intervention (IBI)
arm group type: Experimental
description: Subjects and parents will complete a Brief Motivational Interview (BMI) incorporating personalized feedback, discussion of choices and changes, and therapist led intervention message relating behavioral change and future goals.
arm group label: Enhanced Usual Care
arm group type: No Intervention
description: Subjects and parents will receive standard trauma care, plus complete brief questionnaires and receive general safety information.
intervention type: Other
intervention name: Interactive interview and tailored family centered seatbelt safety intervention
arm group label: Intervener Brief Intervention (IBI)
criteria: 
gender: All
minimum age: 7 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Peter Ehrlich
investigator title: Co-Principal Investigator