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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04388696
Other study ID # PRO17010174
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date January 31, 2020

Study information

Verified date May 2020
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This pilot quasi-experimental community based trial examines the feasibility of a sexual violence and adolescent relationship abuse prevention program for girls aged 14-19. Feasibility is assessed through participant attendance, retention and program satisfaction measures and interviews are conducted at baseline, end of program and 3 month follow up (endline) about participant experiences.


Description:

The goal of the project is to adapt and pilot a "gender transformative," sexual violence and adolescent relationship abuse prevention program, Sisterhood 2.0, among African American high school-age females in a community-based setting. The Sisterhood 2.0 curriculum was adapted from Program M, created in 2006 by Promundo to address health and empowerment of young women aged 15-24. The curriculum engages young women in questioning rigid and non-equitable stereotypes about masculinity and femininity and how these rigid stereotypes affect their health and well-being. This study will pilot test, using a quasi-experimental design, the participant satisfaction with the program through measures of attendance and retention, and be compared to a job skills development curriculum. This study is significant because there are too few evidence-based sexual violence and adolescent relationship abuse prevention program in the U.S., none that are specifically tailored for African American adolescent females, and there are no evidence- based programs implemented in community settings that target both sexual violence and adolescent relationship abuse and adolescent sexual health.


Recruitment information / eligibility

Status Completed
Enrollment 246
Est. completion date January 31, 2020
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 13 Years to 19 Years
Eligibility Inclusion Criteria:

- Participants must be ages 13-19 (inclusive)

- Participants must speak English

- Participants must self identify as female

Exclusion Criteria:

- Not ages 13-19 (inclusive)

- Does not speak English

- Does not identify as female

Study Design


Intervention

Behavioral:
Sisterhood 2.0
The Sisterhood 2.0 curriculum was adapted from Program M, created in 2006 by Promundo to address health and empowerment of young women aged 15-24. The curriculum engages young women in questioning rigid and non-equitable stereotypes about masculinity and femininity and how they affect both women's and men's health and well-being.

Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (4)

Lead Sponsor Collaborator
University of Pittsburgh Department Human Services, Pennsylvania, Fisa Foundation, The Grable Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Participant Attendance Attendance recorded at beginning and end of each session with a weekly satisfaction survey. Calculated as a proportion of total number of sessions. through study completion, an average of 1 per week
Primary Participant Retention At the end of the program, participants were asked why they returned or did not return to the program each week and their reasons for missing any sessions. post-intervention at Week 8
Primary Participant Satisfaction Participants were asked about how satisfied they were with the topic discussed and format of the program each week. through study completion, an average of 1 per week
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