A Feasibility Trial of Sisterhood 2.0

May 14, 2020 updated by: Elizabeth Miller, University of Pittsburgh

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sisterhood 2.0

Sisterhood 2.0 used a group format with activities that explore respect, nonviolence, healthy relationships, and sexuality, through 8 sessions (3 hours/session) over an 8 week period.

Sessions focus on gender, consider harmful messages around femininity and their image, healthy sexuality, healthy relationships and connections, understanding sexual abuse and assault, and self care.

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.
ACTIVE_COMPARATOR: Job Skills Training
The curriculum used for this program is an intensive 18-24 hour job readiness training curriculum distributed across 3 weeks, or up to 2 months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Attendance
Time Frame: through study completion, an average of 1 per week
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
Participant Retention
Time Frame: post-intervention at Week 8
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
Participant Satisfaction
Time Frame: through study completion, an average of 1 per week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

January 31, 2020

Study Registration Dates

First Submitted

May 11, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (ACTUAL)

May 14, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 14, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PRO17010174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The research team will not make individual participant data (IPD) available to other researchers. This plan to Share IPD is consistent with the IPD Sharing Plan Description for our collaborating agency.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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