- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03392597
Preventing Sexual Violence Among Middle School Boys With a Strengths-Based Curriculum
March 14, 2019 updated by: Janis Whitlock, New York State Department of Health
Testing the Efficacy of a Strengths-Based Curriculum to Reduce Risk for Future Sexual Violence Perpetration Among Middle School Boys
This research will examine if participation in a strengths-based curriculum, the Brothers as Allies program adapted from the Council for Boys and Young Men, reduces risk for future sexual violence perpetration among middle school-aged boys in New York State.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Using a longitudinal waitlist control design, this study will evaluate the efficacy of a strengths-based curriculum, the Brothers as Allies program from the Council for Boys and Young Men, to reduce risk for future sexual violence perpetration with middle school-aged boys (ages 12-14) in New York State.
This research will examine if participation in the program decreases negative behaviors (such as later sexual violence perpetration and sexual aggression) and increases positive behaviors (such as bystander intervention and caring/cooperative behaviors) amongst program participants, in comparison to participants who participate in programming-as-usual.
Other potential moderators and outcomes linked to sexual violence victimization and sexual assault perpetration (including attitudes related to gender roles, acceptance of sexual violence, and interpersonal relationships) will also be measured.
The research team will also assess the extent to which the curriculum, when implemented with fidelity and quality, leads to improved relationships and stronger connections with adults in afterschool or other community-based youth-program settings.
All participants will complete surveys at baseline, immediate post-intervention, and at 3 and 6 months post-intervention.
Finally, the investigators will also assess the implementation factors which impact the efficacy of this program, such as fidelity and quality of program delivery.
The research team hypothesizes participants in the Brothers as Allies program will show post-intervention decreased sexual violence perpetration, less acceptance of sexual violence, less stereotypic gender role attitudes, greater youth-adult connectedness, and increased bystander intervention, caring, and cooperation behaviors compared to peers in the non-intervention group.
In order to complete this work, the research team is collaborating with the New York Rape Prevention and Education (RPE)-funded Regional Centers for Sexual Violence Prevention and a Research Advisory Board of community members and professionals from New York State.
Study Type
Interventional
Enrollment (Anticipated)
720
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Rochester, New York, United States, 14605
- Recruiting
- Planned Parenthood of Central and Western New York
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Contact:
- Greta A Niu, PhD
- Phone Number: 362 585-546-2771
- Email: greta.niu@ppcwny.org
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Participants must be males of middle school age (12-14 years), participating in afterschool/youth programming at one of the intervention or control sites.
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Brothers as Allie
Brothers as Allies is a strengths-based group approach to promote boys' and young men's safe and healthy passage through the pre-teen and adolescent years by addressing rigid beliefs and norms about masculinity that are harmful to the health, safety, relationships and opportunities of boys and young men.
Groups of six to ten boys of similar age and development meet weekly with one or two facilitators for 1.5 to 2 hours for ten or more weeks.
Meetings include warm up activities, an opportunity for check-in, experiential activities that address gender relevant topics (e.g., group challenges, games, skits, role plays), and a reflection and group dialogue component.
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Strengths-based group approach to promote boys' and young men's safe and healthy passage through the pre-teen and adolescent years.
|
|
Active Comparator: Programming-as-Usual
Usual programming implemented in afterschool programs.
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Usual afterschool programming.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sexual violence perpetration (Koss et al., 2006)
Time Frame: 3 months
|
This will be measured by items from a widely used measure of sexual violence perpetration behaviors
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Janis Whitlock, PhD, Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 26, 2017
Primary Completion (Anticipated)
July 24, 2020
Study Completion (Anticipated)
September 29, 2020
Study Registration Dates
First Submitted
August 3, 2017
First Submitted That Met QC Criteria
January 2, 2018
First Posted (Actual)
January 8, 2018
Study Record Updates
Last Update Posted (Actual)
March 15, 2019
Last Update Submitted That Met QC Criteria
March 14, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- CE002834
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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