NCT06176300

Brief Summary

The goal of this research study is to implement and evaluate a comprehensive community-level approach, Healthy Communities for Youth, that includes both a selective hospital-based prevention strategy, Emerging Leaders, and universal prevention strategies that increase Positive Youth Development opportunities through participatory action research, stakeholder education, community mobilization, and an overall focus on increasing community capacity for prevention. Key project aims are to evaluate the impact of Healthy Communities for Youth on community rates of youth violence using surveillance data and evaluate the impact of each violence prevention strategy on proximal outcomes including their impact on risk factors and protective processes related to multiple forms of youth violence.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
3,390

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Feb 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Feb 2022May 2026

Study Start

First participant enrolled

February 16, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

December 4, 2023

Last Update Submit

April 29, 2026

Conditions

Outcome Measures

Primary Outcomes (11)

  • Reactive-Proactive Aggression Questionnaire (RPQ)

    23 item measures of aggression and antisocial behavior

    Baseline and 6 months after baseline

  • Beliefs About Aggression and Alternatives (BAA)

    12 item measures that uses a 4-point Likert scale to assess agreement and disagreement on items involving the use of aggression

    Baseline and 6 months after baseline

  • Firearm Aggression Questionnaire (FAQ)

    Self-report assessments of violence involving firearms

    Baseline and 6 months after baseline

  • Gun Violence Questionnaire (GVQ)

    Self-report assessments of violence involving firearms

    Baseline and 6 months after baseline

  • Peer Pressure for Fighting (PPF)

    A questionnaire about peer pressure for fighting is a subscale derived from the Problem Behavior Frequency Scales-Adolescent Report

    Baseline and 6 months after baseline

  • Youth Dating Violence Questionnaire (YDVQ)

    21 item measure that assesses youth dating violence perpetration

    Baseline and 6 months after baseline

  • Engagement in Community Advocacy

    Youth report on the frequency with which they have engaged in these specified community advocacy activities.

    Baseline and 17 weeks later

  • Orientation to Community Advocacy

    Youth report on how much they agree with statements that indicate and orientation of working cooperatively with others for community advocacy and change.

    Baseline and 17 weeks later

  • Emotional Motivation to Engage in Community Advocacy

    Youth report on how much they agree with statements about feeling anger in the face of thinking about and learning about social injustice and the extent to which they engage in specific emotion regulation strategies when feeling this anger.

    Baseline and 17 weeks later

  • Civic Engagement

    Youth report on how important it is to have certain social responsibility and political beliefs, the frequency with which they volunteer, their voting intentions in the future, and their news consumption.

    Baseline and 17 weeks later

  • Critical Consciousness

    Youth report on how much they agree with statements that reflect the awareness, perception, and reflection on societal experiences of inequality.

    Baseline and 17 weeks later

Secondary Outcomes (10)

  • Developmental Assets Profile (DAP)

    Baseline and 6 months after baseline

  • Behavior Assessment System for Children (BASC)

    Baseline and 6 months after baseline

  • Adverse Childhood Experiences (ACES)

    Baseline and 6 months after baseline

  • Research skills & Orientation Toward Research

    Baseline and 17 weeks after baseline

  • Leadership Skills

    Baseline and 17 weeks after baseline

  • +5 more secondary outcomes

Study Arms (3)

Community A

EXPERIMENTAL
Behavioral: PAR - the SEED MethodBehavioral: PAR-Youth VoicesBehavioral: Emerging Leaders hospital-based intervention

Community B

EXPERIMENTAL
Behavioral: PAR - the SEED MethodBehavioral: PAR-Youth VoicesBehavioral: Emerging Leaders hospital-based intervention

Community C

NO INTERVENTION

Interventions

The SEED Method is an evidence-based Participatory Action Research (PAR) approach that engages youth and adult stakeholders in collective decision-making and action in supporting PYD opportunities in their communities.

Community ACommunity B

Youth Voices is a developmentally appropriate and culturally responsive PAR approach designed for African American adolescents. The curriculum relies on frameworks including sociopolitical development (e.g., civic engagement and social justice), racial socialization, and racial identity development. Youth Voices will be implemented in high schools serving the intervention communities.

Community ACommunity B

Emerging Leaders is a violence prevention strategy that provides evidence-based intervention and resources for high-risk youth and their families in the youth's home and community. Emerging Leaders consists of four core components to prevent violence: (1) brief hospital-based violence intervention, (2) 3-months of community case management, (3) an in-home firearm safety counseling program, and (4) an 8-week youth positive development workshop series.

Community ACommunity B

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Community residents, youth aged 12-17 and parents, living in one of the intervention communities (Community A and Community B)
  • Stakeholders who reside or work in one of the intervention communities (Community A and Community B) or who contribute other expertise
  • Be able to consent/assent
  • Exlcusion criteria:
  • Those with limited English proficiency
  • Emerging Leaders:
  • Violently injured or high-risk youth that have either received or are receiving treatment or had a family member or relative receive treatment at VCU Health, or who live in one of the intervention communities, or have been referred by a community partner.
  • Aged 14 through 24
  • Reside in one of the two intervention communities (Community A and Community B) or in the control community (Community C)
  • Be able to consent/assent

You may not qualify if:

  • Youth younger than 14 and older than 24 will be excluded.
  • Prisoners will be excluded.
  • Those living outside our community boundaries will be excluded.
  • PAR/Youth Voices:
  • Youth in grades 9 through 12
  • Reside in one of the intervention communities (Community A and Community B) and attend the designated high school(s) serving that community (Community A or Community B)
  • Be able to consent/assent
  • Youth in grades below 9th
  • Youth who have graduated from high school
  • Youth recruited for School A, cannot reside in the catchment areas for Communities B or C. Youth recruited for School B, cannot reside in the catchment areas for Communities A or C. Youth recruited for School C, cannot reside in the catchment areas for Communities A or B.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Terri Sullivan, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: Three intervention strategies (i.e., PAR - the SEED Method and Youth Voices, Emerging Leaders hospital-based intervention, and Stakeholder Education) form the community-level approach to prevent youth violence. The interventions will be implemented in communities in randomized order to evaluate their combined influence.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 19, 2023

Study Start

February 16, 2022

Primary Completion (Estimated)

May 30, 2026

Study Completion (Estimated)

May 30, 2026

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations