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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03392597
Other study ID # CE002834
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 26, 2017
Est. completion date September 29, 2020

Study information

Verified date March 2019
Source New York State Department of Health
Contact Ann-Margret Foley
Phone 518-474-0535
Email ann-margret.foley@health.ny.gov
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 720
Est. completion date September 29, 2020
Est. primary completion date July 24, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 12 Years to 14 Years
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Brothers as Allies
Strengths-based group approach to promote boys' and young men's safe and healthy passage through the pre-teen and adolescent years.
Programming-as-Usual
Usual afterschool programming.

Locations

Country Name City State
United States Planned Parenthood of Central and Western New York Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
New York State Department of Health Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sexual violence perpetration (Koss et al., 2006) This will be measured by items from a widely used measure of sexual violence perpetration behaviors 3 months
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