NCT04388696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

6 months

First QC Date

May 11, 2020

Last Update Submit

May 14, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Sisterhood 2.0

EXPERIMENTAL

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.

Behavioral: Sisterhood 2.0

Job Skills Training

ACTIVE COMPARATOR

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.

Behavioral: Sisterhood 2.0

Interventions

Sisterhood 2.0BEHAVIORAL

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.

Job Skills TrainingSisterhood 2.0

Eligibility Criteria

Age13 Years - 19 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSelf identifying females aged 13-19.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Participants must be ages 13-19 (inclusive)
  • Participants must speak English
  • Participants must self identify as female

You may not qualify if:

  • Not ages 13-19 (inclusive)
  • Does not speak English
  • Does not identify as female

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Adolescent BehaviorCoitusCommunication

Condition Hierarchy (Ancestors)

BehaviorSexual Behavior

Study Officials

  • Elizabeth Miller, MD, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 14, 2020

Study Start

December 1, 2018

Primary Completion

June 1, 2019

Study Completion

January 31, 2020

Last Updated

May 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

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.

Locations