Adolescent BehaviorNCT04388696
A Feasibility Trial of Sisterhood 2.0
A study testing Sisterhood 2.0 in people with Adolescent Behavior and Violence in Adolescence, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 13 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior, Violence in Adolescence, Group, Peer
- What is being tested?
- Sisterhood 2.0
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2018to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Participants must be ages 13-19 (inclusive)
- Participants must speak English
- Participants must self identify as female
Who cannot join
- Not ages 13-19 (inclusive)
- Does not speak English
- Does not identify as female
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
Read the 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.
- Conditions
- Adolescent Behavior, Violence in Adolescence, Group, Peer, Violence, Non-accidental, Violence, Sexual, Violence, Physical
- Being tested
- Sisterhood 2.0
- Medical subject headings
- Adolescent Behavior, Coitus, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sisterhood 2.0Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Sisterhood 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 per week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2020
- Study start1 Dec 2018
- Primary completion1 Jun 2019
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Department Human Services, Pennsylvania, Fisa Foundation, The Grable Foundation
- Responsible party
- Principal investigator, Elizabeth Miller, University of Pittsburgh
- Investigators
- Elizabeth Miller, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04388696
- Sponsor's protocol ID
- PRO17010174
- Status last verified
- May 2020
- First submitted
- 11 May 2020
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Gender Transformative Program to Prevent Sexual Violence and Relationship Abuse Among Adolescent Women: A Feasibility Trial of Sisterhood 2.0
- ClinicalTrials.gov ID
- NCT04388696
- Acronym / sponsor ID
- PRO17010174
- Conditions
- Adolescent Behavior, Violence in Adolescence, Group, Peer, Violence, Non-accidental, Violence, Sexual, Violence, Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Department Human Services, Pennsylvania, Fisa Foundation, The Grable Foundation
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 14 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sisterhood 2.0 | Experimental | Behavioral: Sisterhood 2.0Sisterhood 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. |
| Job Skills Training | Active comparator | Behavioral: Sisterhood 2.0The curriculum used for this program is an intensive 18-24 hour job readiness training curriculum distributed across 3 weeks, or up to 2 months. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Participants must be ages 13-19 (inclusive)
- Participants must speak English
- Participants must self identify as female
Key exclusion criteria (3 listed)
- Not ages 13-19 (inclusive)
- Does not speak English
- Does not identify as female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sisterhood 2.0The 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. | Behavioural | Job Skills Training, Sisterhood 2.0 |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Miller, MD, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sisterhood 2.0 in people with Adolescent Behavior and Violence in Adolescence, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Attendance (time frame: through study completion, an average of 1 per week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.