Clinical trial NCT04388696: A Feasibility Trial of Sisterhood 2.0
Official title: A Gender Transformative Program to Prevent Sexual Violence and Relationship Abuse Among Adolescent Women: A Feasibility Trial of Sisterhood 2.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Behavior
Violence in Adolescence
Group, Peer
Violence, Non-accidental
Violence, Sexual
Violence, Physical
Violence, Domestic
Emotional Abuse
Coping Skills
Communication, Personal
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Department Human Services, Pennsylvania
name: Fisa Foundation
name: The Grable Foundation
First posted: 2020-05-14
Enrollment: 246
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The 18-24 hour content (divided into 8, 3 hour sessions) are spread over a 3 week to 2 month period. Sessions explored gender, consider harmful messages around femininity and socially acceptable images of women, healthy sexuality, healthy relationships and connections, understanding and identifying sexual abuse and assault, and self care.

Control Program: The control intervention used widely-used curricula focused on job skills development and life skills. Trained prevention educators provided the programs for both intervention and control arms and were trained to implement either the Sisterhood 2.0 program or the job skills curriculum.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participant Attendance
timeFrame: through study completion, an average of 1 per week
measure: Participant Retention
timeFrame: post-intervention at Week 8
measure: Participant Satisfaction
timeFrame: through study completion, an average of 1 per week
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth Miller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: