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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02506088
Other study ID # 1U01CE002531
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date October 2018

Study information

Verified date October 2018
Source Lifespan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present research creates a partnership between researchers and a community agency to evaluate whether a sexual assault prevention program for high school students reduces perpetration of sexual violence among high school boys.


Description:

The present research advances the science of sexual assault prevention by creating a mutually beneficial partnership between well-established sexual assault prevention researchers and a CDC Rape Prevention and Education Program (RPE)-funded community agency to conduct a rigorous experimental evaluation of universal primary prevention programming designed to reduce sexual aggression among high school boys. The present research tests multi-session prevention programming that targets change at multiple levels of the social ecology (i.e., individual-, peer- and community-level) through social norms theory and bystander education. Specifically, the present research evaluates Your Voice Your View. Your Voice Your View was developed and is currently administered in Rhode Island High Schools by the CDC RPE-funded agency Day One of Rhode Island. The program will be tested in a group randomized cluster trial among 10th graders at 30 high schools, with the aim of reducing perpetration of sexual aggression among high school boys.

Specifically, this research will conduct a randomized controlled trial with a sample of 10th grade students to demonstrate efficacy of the intervention in reducing rates of sexual aggression among high school boys, rates of dating violence involvement, and related risk and protective factors over a 2- and 6-month follow-up in comparison to a wait-list control group. Thirty schools will be matched on demographic characteristics (i.e., % receiving subsidized lunch, racial/ethnic minority enrollment) and randomized to receive Your Voice Your View or to the wait-list control group.


Recruitment information / eligibility

Status Completed
Enrollment 7910
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Adolescents at Rhode Island high schools will be eligible for enrollment according to the following criteria: 1) adolescent assent given; 3) passive consent of a parent/legal guardian is given. Teachers will be eligible to participate in educator assessments if consent is given.

Exclusion Criteria:

- There are no exclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Your Voice Your View
Session 1 of the intervention involves background information, an introduction to social norms, and bystander intervention skills training. Session 2 of the intervention establishes conditions for consent, types of abusive behavior and identifying abuse. Session 3 of the intervention addresses risk reduction strategies for girls. Session 3 of the intervention addresses false accusations, masculinity, and additional practice on identifying conditions for consent for boys. Session 4 of the intervention includes active practice of bystander intervention skills.

Locations

Country Name City State
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Lifespan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perpetration of Sexual Violence Survey up to 6-months
Secondary Rate of Dating Violence Perpetration up to 6 months
Secondary Rape Myth Acceptance Survey up to 6 months
Secondary Bystander Intervention Skills Survey Composite measure: Increase Positive Bystander Behavior, Decrease Barriers to Intervening, Increase Likelihood of Intervening up to 6 months
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