- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05743478
Forging Hopeful Futures to Reduce Youth Violence (FHF)
April 24, 2024 updated by: Alison Culyba, University of Pittsburgh
Forging Hopeful Futures: A Racial and Gender-Justice Program to Reduce Youth Violence
This cluster-randomized community-partnered study will examine the effectiveness of a racial-, gender-, and economic-justice focused youth violence prevention program called Forging Hopeful Futures with youth ages 13-19.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This community-partnered cluster randomized trial in 16 neighborhoods impacted by structural inequities and high levels of community violence in Pittsburgh, PA and urban Washington D.C. and Maryland metro areas will evaluate effectiveness of Forging Hopeful Futures with youth ages 13-19.
Forging Hopeful Futures combines economic justice content from job readiness training, racial and gender justice content from gender-transformative programming, and leadership building as a novel multi-level violence prevention intervention.
Study Type
Interventional
Enrollment (Estimated)
720
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 Contact
- Name: Afton Kirk-Johnson, PhD
- Phone Number: 412-692-6056
- Email: kirkjohnsona@upmc.edu
Study Contact Backup
- Name: Alexander Riley
- Phone Number: 412-692-7944
- Email: alexander.riley8@chp.edu
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20008
- Not yet recruiting
- Population Council
-
Contact:
- Julie Pulerwitz, ScD
- Phone Number: 202-237-9400
- Email: jpulerwitz@popcouncil.org
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Recruiting
- University of Pittsburgh
-
Contact:
- Alexander Riley
- Phone Number: 412-692-7944
- Email: alexander.riley8@chp.edu
-
Principal Investigator:
- Alison J Culyba, MD PhD MPH
-
Contact:
- Afton Kirk-Johnson
- Email: kirkjohnsona@upmc.edu
-
-
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
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants must be ages 13-19 (inclusive)
- Participants must speak English
- Participants must live in the participating neighborhoods, attend schools in the participating neighborhoods, or use participating facilities
- Participants must be able to provide follow up contact information
Exclusion Criteria:
- Not ages 13 -19 (inclusive)
- Do not speak English
- Do not live in the participating neighborhoods, attend schools in the participating neighborhoods, or use participating facilities
- Unable to provide follow up contact information
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 Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Wellness Check-ins
Youth in neighborhoods randomized to the control group will receive individual wellness checks.
This will occur through a strengths-based telephone conversation focused on wellness resources.
Youth will be provided with tailored resources based on needs identified during the call.
Youth will be offered the option for additional phone check-ins to coordinate access to community resources and connection to individualized behavioral health supports if desired.
|
Individual wellness checks will occur through a strengths-based telephone conversation focused on wellness resources.
Youth will be provided with tailored resources based on needs identified during the call.
Youth will be offered the option for additional phone check-ins to coordinate access to community resources and connection to individualized behavioral health supports if desired.
|
Experimental: Forging Hopeful Futures
Forging Hopeful Futures uses a group discussion format with activities that explore race, gender, class, identity, relationships, and multiple forms of violence.
Forging Hopeful Futures is a 12 session curriculum for youth ages 13-19 that uses strengths-based and healing-centered approaches to critically examine structural forces that perpetuate racial and gender injustice, develop leadership skills in promoting gender equitable relationship norms, non-violent practices, and upstander skills, and enhance economic justice through job skills and employment opportunities.
Through 12 sessions (3 hours/session) over a 6 to 12 week period, Forging Hopeful Futures combines racial, gender, and economic justice content with leadership development and workforce development opportunities.
|
Forging Hopeful Futures is a 12 session curriculum for youth ages 13-19 that uses strengths-based and healing-centered approaches to critically examine structural forces that perpetuate racial and gender injustice, develop leadership skills in promoting gender equitable relationship norms, non-violent practices, and upstander skills, and enhance economic justice through job skills and employment opportunities.
Through 12 sessions (3 hours/session) over a 6 to 12 week period, Forging Hopeful Futures combines racial, gender, and economic justice content with leadership development and workforce development opportunities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in recent violence perpetration at 3 months
Time Frame: At baseline and three months after program conclusion
|
The primary outcome will be past 3-month youth violence perpetration.
This will be measured by self-report on 3 items adapted from the Youth Risk Behavior Surveillance Survey, using a past-3 month reporting interval: 1) physical fighting ("How many times were you in a physical fight?"), 2) threatening someone with a weapon ("How many times have you threatened someone with a weapon such as a gun, knife, or club?"), and 3) injuring someone with a weapon ("How many times have you injured someone with a weapon such as a gun, knife, or club?").
Each item will be assessed with 8 frequency response categories from 0 times to 12 or more times.
A summary score will capture the past 3-month incidence of all 3 behaviors (possible range: 0- 21;lower score indicates better outcome)
|
At baseline and three months after program conclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in recent violence perpetration at 6 months
Time Frame: At baseline and six months after program conclusion
|
This will be measured using the same 3 items outlined in the primary outcome, but assessed as a change from baseline to 6 months after program conclusion.
This includes self-report on 3 items adapted from the Youth Risk Behavior Surveillance Survey, using a past-3 month reporting interval: 1) physical fighting ("How many times were you in a physical fight?"), 2) threatening someone with a weapon ("How many times have you threatened someone with a weapon such as a gun, knife, or club?"), and 3) injuring someone with a weapon ("How many times have you injured someone with a weapon such as a gun, knife, or club?").
Each item will be assessed with 8 frequency response categories from 0 times to 12 or more times.
A summary score will capture the past 3-month incidence of all 3 behaviors (possible range: 0- 21;lower score indicates better outcome)
|
At baseline and six months after program conclusion
|
Change in relationship abuse at 3 months
Time Frame: At baseline and three months after program conclusion
|
10 abusive behavior items, modified from Conflict Tactics Scale-2, assess for perpetration against dating partners or towards peers.
Summary score of any recent use of violence in the past 3 months (physical, sexual and emotional relationship abuse) calculated as one point for each behavior then summed (possible range: 0-10; lower score indicates better outcome).
|
At baseline and three months after program conclusion
|
Change in sexual violence perpetration at 3 months
Time Frame: At baseline and three months after program conclusion
|
4 sexual violence perpetration items assess recent sexual violence perpetration (any/none).
Summary score of any recent sexual violence perpetration in the past 3 months, calculated as one point for each behavior then summed (possible range: 0-4; lower score indicates better outcome).
|
At baseline and three months after program conclusion
|
Change in cyber dating abuse and peer abuse
Time Frame: At baseline and three months after program conclusion
|
8 items assess using technology to perpetrate abuse against a dating partner or peers.
Summary score of any recent use of technology to perpetrate abuse against a dating partner or peers in the past 3 months, calculated as one point for each behavior then summed (possible range: 0-8; lower score indicates better outcome).
|
At baseline and three months after program conclusion
|
Change in bullying perpetration
Time Frame: At baseline and three months after program conclusion
|
6 items to indicate frequency of bullying perpetration on 4-point frequency scale.
Mean score of any recent bullying perpetration in the past 3 months, calculated as a mean score across the 6 items (possible range: 0-3; lower score indicates better outcome).
|
At baseline and three months after program conclusion
|
Change in cyberbullying perpetration
Time Frame: At baseline and three months after program conclusion
|
4-item scale adapted from a cyberbullying perpetration scale, assessing perpetration frequency on a 4-point frequency scale.
Mean score of recent cyberbullying perpetration in the past 3 months, calculated as a mean across the 4 items (possible range:0-3; lower score indicated better outcome).
|
At baseline and three months after program conclusion
|
Change in weapon carrying
Time Frame: At baseline and three months after program conclusion
|
1 item adapted from the Youth Risk Behavior Surveillance Survey asking about frequency of carrying a weapon in the past 30 days (measured on a 5-point frequency scale from 0 days to 6 or more days; possible range: 0-4; lower score indicates better outcome).
|
At baseline and three months after program conclusion
|
Change in homophobic teasing
Time Frame: At baseline and three months after program conclusion
|
5-item scale with participants reporting how often they have perpetrated listed behaviors in the past 3 months (each item measured on a 6-point frequency scale from 0 times to 7 or more times).
Mean score of recent homophobic teasing, calculated as a mean across the 5 items (possible range: 0-5; lower score indicates better outcome).
|
At baseline and three months after program conclusion
|
Change in sexual harassment
Time Frame: At baseline and three months after program conclusion
|
5 items assess frequency of perpetrating sexual harassing behaviors in the past 3 months, assessing perpetration frequency on a 5-point frequency scale.
Mean score of recent sexual harassment perpetration in the past 3 months, calculated as a mean across the 5 items (possible range:0-4; lower score indicated better outcome).
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At baseline and three months after program conclusion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alison Culyba, MD PhD MPH, University of Pittsburgh
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)
July 10, 2023
Primary Completion (Estimated)
September 30, 2025
Study Completion (Estimated)
September 30, 2025
Study Registration Dates
First Submitted
February 13, 2023
First Submitted That Met QC Criteria
February 14, 2023
First Posted (Actual)
February 24, 2023
Study Record Updates
Last Update Posted (Estimated)
April 26, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
July 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- STUDY22080150
- R01CE003502 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
IDP data will be made available only to selected researchers who apply for access.
The application must document a legitimate public health use or research question for the data, and the applicant must sign a pledge to keep all data private and to make no attempt to identify individual subjects.
Access can be requested for all of the individual participant data collected during the trial, after deidentification.
We will use data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use.
Along with restricted use of the IDP, we will make available a comprehensive data dictionary that details all data elements included in the dataset, and sources of validated instruments.
This use of the data is consistent with the planned language of the voluntary consent for participation agreed and in accordance with IRB policy.
IPD Sharing Time Frame
We will adhere to data sharing timelines, including sharing data (restricted use) within 30 months after the end of data collection.
IPD Sharing Access Criteria
We will make the data available only to selected researchers who apply for access.
The application must document a legitimate public health use or research question for the data, and the applicant must sign a pledge to keep all data private and to make no attempt to identify individual subjects.
This use of the data is consistent with the planned language of the voluntary consent for participation agreed and in accordance with IRB policy.
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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