A Feasibility Trial of Sisterhood 2.0

Adolescent Behavior Clinical Trial

Official title:

A Gender Transformative Program to Prevent Sexual Violence and Relationship Abuse Among Adolescent Women: A Feasibility Trial of Sisterhood 2.0

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04388696
• Other study ID #: PRO17010174
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Adolescent Behavior
• Communication, Personal
• Coping Skills
• Emotional Abuse
• Group, Peer
• Violence in Adolescence
• Violence, Domestic
• Violence, Non-accidental
• Violence, Physical
• Violence, Sexual

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