<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/NCT03839797</url>
  </required_header>
  <id_info>
    <org_study_id>FAC20170050H</org_study_id>
    <nct_id>NCT03839797</nct_id>
  </id_info>
  <brief_title>Cadet Healthy Personal Skills Intervention Trial</brief_title>
  <acronym>CHiPS</acronym>
  <official_title>Adapting, Developing, And Testing An Evidence-Based Life Skills Training Approach For Sexual Assault Prevention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Health Promotion Associates, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Air Force</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>National Health Promotion Associates, Inc.</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>
      The purpose of this study is to evaluate a new approach to sexual violence prevention by&#xD;
      promoting healthy relationships and personal life skills among incoming Air Force cadets at&#xD;
      the United States Air Force Academy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      National Health Promotion Associates (NHPA) adapted the Botvin Life Skills Training (LST)&#xD;
      program for incoming fourth class cadets at the United States Air Force Academy (USAFA). The&#xD;
      resulting adaptation, called Cadet Healthy Personal Skills (CHiPS), provides cadets with the&#xD;
      knowledge, attitudes, and skills to enhance their personal resilience, increase their&#xD;
      potential for success, help them develop healthy and rewarding personal relationships, and&#xD;
      reduce sexual harassment and assault. The CHiPS program includes ten units, spread across&#xD;
      three blocks of content, and each block teaches cadets a range of life skills. All incoming&#xD;
      fourth class cadets (N=1,203) were invited to participate in this study, beginning in the&#xD;
      Summer of 2017, and of those, 1,098 cadets (91.3%) consented to participate in the&#xD;
      trial.Twenty-five facilitators were trained to implement the newly adapted CHiPS program.&#xD;
      Half of the incoming class [four Basic Cadet Training (BCT) squadrons] was assigned to&#xD;
      receive the intervention, while the other half (four BCT squadrons) continued to receive&#xD;
      standard trainings already in place at USAFA. All cadets completed a self-report survey at&#xD;
      pretest, posttest, and at a 12-month follow-up&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 27, 2017</start_date>
  <completion_date type="Actual">August 30, 2018</completion_date>
  <primary_completion_date type="Actual">August 5, 2017</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>
    <intervention_model_description>Half of the squadrons of incoming cadets were randomized to the CHiPS intervention, the other half were randomized to the control condition</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported sexual acts without consent</measure>
    <time_frame>Past 1 year</time_frame>
    <description>Three survey items assessed whether the participant was kissed or sexually touched without active consent, penetration or oral sex without active consent, or had sexual intercourse without consent and too intoxicated to resist.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1050</enrollment>
  <condition>Sexual Behavior</condition>
  <condition>Skills, Social</condition>
  <condition>Skills, Coping</condition>
  <arm_group>
    <arm_group_label>Cadet Healthy Personal Skills</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cadet Healthy Personal Skills</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Health Education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Health Education</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cadet Healthy Personal Skills</intervention_name>
    <description>7.5 hour skills training group intervention</description>
    <arm_group_label>Cadet Healthy Personal Skills</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Health Education</intervention_name>
    <description>Standard Health Education</description>
    <arm_group_label>Standard Health Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  incoming cadet at USAFA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>
  <overall_official>
    <last_name>Kenneth W Griffin, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Health Promotion Associates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Health Promotion Associates</name>
      <address>
        <city>White Plains</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 4, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 12, 2019</last_update_submitted>
  <last_update_submitted_qc>February 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Health Promotion Associates, Inc.</investigator_affiliation>
    <investigator_full_name>Kenneth W Griffin</investigator_full_name>
    <investigator_title>Senior Research Scientist</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/NCT03839797
org study id: FAC20170050H
nct id: NCT03839797
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate a new approach to sexual violence prevention by
      promoting healthy relationships and personal life skills among incoming Air Force cadets at
      the United States Air Force Academy.
National Health Promotion Associates (NHPA) adapted the Botvin Life Skills Training (LST)
      program for incoming fourth class cadets at the United States Air Force Academy (USAFA). The
      resulting adaptation, called Cadet Healthy Personal Skills (CHiPS), provides cadets with the
      knowledge, attitudes, and skills to enhance their personal resilience, increase their
      potential for success, help them develop healthy and rewarding personal relationships, and
      reduce sexual harassment and assault. The CHiPS program includes ten units, spread across
      three blocks of content, and each block teaches cadets a range of life skills. All incoming
      fourth class cadets (N=1,203) were invited to participate in this study, beginning in the
      Summer of 2017, and of those, 1,098 cadets (91.3%) consented to participate in the
      trial.Twenty-five facilitators were trained to implement the newly adapted CHiPS program.
      Half of the incoming class [four Basic Cadet Training (BCT) squadrons] was assigned to
      receive the intervention, while the other half (four BCT squadrons) continued to receive
      standard trainings already in place at USAFA. All cadets completed a self-report survey at
      pretest, posttest, and at a 12-month follow-up
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Half of the squadrons of incoming cadets were randomized to the CHiPS intervention, the other half were randomized to the control condition
primary purpose: Prevention
masking: None (Open Label)
measure: Self-reported sexual acts without consent
time frame: Past 1 year
description: Three survey items assessed whether the participant was kissed or sexually touched without active consent, penetration or oral sex without active consent, or had sexual intercourse without consent and too intoxicated to resist.
arm group label: Cadet Healthy Personal Skills
arm group type: Experimental
description: Cadet Healthy Personal Skills
arm group label: Standard Health Education
arm group type: Active Comparator
description: Standard Health Education
intervention type: Behavioral
intervention name: Cadet Healthy Personal Skills
description: 7.5 hour skills training group intervention
arm group label: Cadet Healthy Personal Skills
intervention type: Behavioral
intervention name: Standard Health Education
description: Standard Health Education
arm group label: Standard Health Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kenneth W Griffin, PhD
role: Principal Investigator
affiliation: National Health Promotion Associates
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: National Health Promotion Associates, Inc.
investigator full name: Kenneth W Griffin
investigator title: Senior Research Scientist