NCT05743478

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
4mo left

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 Progress90%
Jul 2023Aug 2026

First Submitted

Initial submission to the registry

February 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 10, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

3.1 years

First QC Date

February 13, 2023

Last Update Submit

November 3, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in recent violence perpetration at 3 months

    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 Outcomes (9)

  • Change in recent violence perpetration at 6 months

    At baseline and six months after program conclusion

  • Change in relationship abuse at 3 months

    At baseline and three months after program conclusion

  • Change in sexual violence perpetration at 3 months

    At baseline and three months after program conclusion

  • Change in cyber dating abuse and peer abuse

    At baseline and three months after program conclusion

  • Change in bullying perpetration

    At baseline and three months after program conclusion

  • +4 more secondary outcomes

Study Arms (2)

Forging Hopeful Futures

EXPERIMENTAL

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.

Behavioral: Forging Hopeful Futures

Wellness Check-ins

ACTIVE COMPARATOR

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.

Behavioral: Wellness Check-ins

Interventions

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

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.

Wellness Check-ins

Eligibility Criteria

Age13 Years - 19 Years
Sexall
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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Population Council

Washington D.C., District of Columbia, 20008, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

RacismAdolescent BehaviorCommunicationCoitus

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial DiscriminationSexual Behavior

Study Officials

  • Alison Culyba, MD PhD MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This community-partnered cluster-randomized study will examine the effectiveness of a racial, gender, and economic justice focused youth violence prevention program called Forging Hopeful Futures among youth ages 13-19.The study will be located in 16 neighborhoods with concentrated disadvantage ('clusters') across Pittsburgh, Pennsylvania and urban Washington D.C. and Maryland metro areas randomized either to receive the "Forging Hopeful Futures" program (i.e., intervention neighborhood, n=8) or wellness check-ins (i.e. control neighborhood, n=8).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 24, 2023

Study Start

July 10, 2023

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

November 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

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.

Time Frame
We will adhere to data sharing timelines, including sharing data (restricted use) within 30 months after the end of data collection.
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.

Locations