Sexual BehaviorCHiPSNCT03839797
Cadet Healthy Personal Skills Intervention Trial
A study testing Cadet Healthy Personal Skills and Standard Health Education in people with Sexual Behavior and Skills, Social, run by National Health Promotion Associates, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Skills, Social, Skills, Coping
- What is being tested?
- Cadet Healthy Personal Skills and Standard Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,050 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2017to 30 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- incoming cadet at USAFA
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
National Health Promotion Associates
White Plains, New York, 10604
About this study
Official title: Adapting, Developing, And Testing An Evidence-Based Life Skills Training Approach For Sexual Assault Prevention
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.
Read the detailed description
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
- Conditions
- Sexual Behavior, Skills, Social, Skills, Coping
- Being tested
- Cadet Healthy Personal Skills, Standard Health Education
- Medical subject headings
- Sexual Behavior, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cadet Healthy Personal SkillsBehavioural
7.5 hour skills training group intervention
Standard Health EducationBehavioural
Standard Health Education
| Study group | Role | What they receive |
|---|---|---|
| Cadet Healthy Personal Skills | Experimental | Cadet Healthy Personal Skills Receives: Behavioral: Cadet Healthy Personal Skills |
| Standard Health Education | Active comparator | Standard Health Education Receives: Behavioral: Standard Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported sexual acts without consent
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.
Measured: Past 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start27 Jun 2017
- Primary completion5 Aug 2017
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Half of the squadrons of incoming cadets were randomized to the CHiPS intervention, the other half were randomized to the control condition
- Masking
- None (open label)
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Promotion Associates, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Air Force
- Responsible party
- Principal investigator, Kenneth W Griffin, National Health Promotion Associates, Inc.
- Investigators
- Kenneth W Griffin, PhD, Principal investigator, National Health Promotion Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839797
- Sponsor's protocol ID
- FAC20170050H
- Acronym
- CHiPS
- Status last verified
- Feb 2019
- First submitted
- 4 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Griffin KW, Williams C, Travis W, Tharp A. Prevention of Unwanted Sexual Contact Among Cadets at the United States Air Force Academy: A Brief Small-Group Intervention. Am J Public Health. 2021 Apr;111(4):672-674. doi: 10.2105/AJPH.2020.306050. Epub 2021 Jan 21.
PubMed 33476231
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting, Developing, And Testing An Evidence-Based Life Skills Training Approach For Sexual Assault Prevention
- ClinicalTrials.gov ID
- NCT03839797
- Acronym / sponsor ID
- CHiPS / FAC20170050H
- Conditions
- Sexual Behavior, Skills, Social, Skills, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- National Health Promotion Associates, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Air Force
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 5 Aug 2017 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Half of the squadrons of incoming cadets were randomized to the CHiPS intervention, the other half were randomized to the control condition
| Arm | Type | Receives |
|---|---|---|
| Cadet Healthy Personal Skills | Experimental | Behavioral: Cadet Healthy Personal SkillsCadet Healthy Personal Skills |
| Standard Health Education | Active comparator | Behavioral: Standard Health EducationStandard Health Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- incoming cadet at USAFA
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cadet Healthy Personal Skills7.5 hour skills training group intervention | Behavioural | Cadet Healthy Personal Skills |
| Standard Health EducationStandard Health Education | Behavioural | Standard Health Education |
Primary outcome
Self-reported sexual acts without consent
Time frame: Past 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 33476231Griffin KW, Williams C, Travis W, Tharp A. Prevention of Unwanted Sexual Contact Among Cadets at the United States Air Force Academy: A Brief Small-Group Intervention. Am J Public Health. 2021 Apr;111(4):672-674. doi: 10.2105/AJPH.2020.306050. Epub 2021 Jan 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth W Griffin, PhD principal investigator
National Health Promotion Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cadet Healthy Personal Skills and Standard Health Education in people with Sexual Behavior and Skills, Social, run by National Health Promotion Associates, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported sexual acts without consent (time frame: Past 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03839797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.