- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06176300
Evaluation of Violence Prevention Strategies to Prevent and Reduce Community Levels of Youth Violence
December 18, 2023 updated by: Virginia Commonwealth University
VCU Healthy Communities for Youth: Evaluation of Violence Prevention Strategies to Prevent and Reduce Community Levels of Youth Violence
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.
Study Overview
Status
Enrolling by invitation
Conditions
Detailed Description
This project focuses on three communities in Richmond selected based on US Census Bureau block groups and their high rates of youth violence and concentrated poverty.
The community-level effects of implementing the comprehensive community-level approach will be evaluated using a multiple baseline design.
The three communities were randomly assigned such that the intervention would begin in one community starting in the fourth quarter of Year 1, a second community in the fourth quarter of Year 2, and the third community will represent a no-intervention control community receiving training and technical assistance at the end of the project.
Analyses will be conducted on community-level surveillance data on violence-related variables to determine if the introduction of the community-level intervention within each community is associated with subsequent changes in outcome measures.
Study Type
Interventional
Enrollment (Estimated)
3390
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 Locations
-
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
PAR-SEED Method:
Inclusion criteria:
- 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 who do not meet the inclusion criteria
- Those with limited English proficiency
Emerging Leaders:
Inclusion criteria:
- 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
Exclusion criteria:
- 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:
Inclusion criteria:
- 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
Exclusion criteria:
- 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.
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: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Community A
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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.
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.
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.
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Experimental: Community B
|
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.
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.
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.
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No Intervention: Community C
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reactive-Proactive Aggression Questionnaire (RPQ)
Time Frame: Baseline and 6 months after baseline
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23 item measures of aggression and antisocial behavior
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Baseline and 6 months after baseline
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Beliefs About Aggression and Alternatives (BAA)
Time Frame: Baseline and 6 months after baseline
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12 item measures that uses a 4-point Likert scale to assess agreement and disagreement on items involving the use of aggression
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Baseline and 6 months after baseline
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Firearm Aggression Questionnaire (FAQ)
Time Frame: Baseline and 6 months after baseline
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Self-report assessments of violence involving firearms
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Baseline and 6 months after baseline
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Gun Violence Questionnaire (GVQ)
Time Frame: Baseline and 6 months after baseline
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Self-report assessments of violence involving firearms
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Baseline and 6 months after baseline
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Peer Pressure for Fighting (PPF)
Time Frame: Baseline and 6 months after baseline
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A questionnaire about peer pressure for fighting is a subscale derived from the Problem Behavior Frequency Scales-Adolescent Report
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Baseline and 6 months after baseline
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Youth Dating Violence Questionnaire (YDVQ)
Time Frame: Baseline and 6 months after baseline
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21 item measure that assesses youth dating violence perpetration
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Baseline and 6 months after baseline
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Engagement in Community Advocacy
Time Frame: Baseline and 17 weeks later
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Youth report on the frequency with which they have engaged in these specified community advocacy activities.
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Baseline and 17 weeks later
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Orientation to Community Advocacy
Time Frame: Baseline and 17 weeks later
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Youth report on how much they agree with statements that indicate and orientation of working cooperatively with others for community advocacy and change.
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Baseline and 17 weeks later
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Emotional Motivation to Engage in Community Advocacy
Time Frame: Baseline and 17 weeks later
|
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.
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Baseline and 17 weeks later
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Civic Engagement
Time Frame: Baseline and 17 weeks later
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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.
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Baseline and 17 weeks later
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Critical Consciousness
Time Frame: Baseline and 17 weeks later
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Youth report on how much they agree with statements that reflect the awareness, perception, and reflection on societal experiences of inequality.
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Baseline and 17 weeks later
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Developmental Assets Profile (DAP)
Time Frame: Baseline and 6 months after baseline
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58 item measure that was developed for youth aged 11-18 to assess the strengths and qualities that are believed to promote resilience and positive development.
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Baseline and 6 months after baseline
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Behavior Assessment System for Children (BASC)
Time Frame: Baseline and 6 months after baseline
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189 item survey that assesses hyperactivity, aggression, conduct problems, and executive function in youth.
It also assesses anxiety, depression, attention and learning problems, as well as the lack of certain essential skills
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Baseline and 6 months after baseline
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Adverse Childhood Experiences (ACES)
Time Frame: Baseline and 6 months after baseline
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It is a 10-item measure intended to assess 10 types of childhood adversity in three different areas of abuse, including emotional and physical abuse, physical neglect, and abuse associated with living in a dysfunctional household.
An ACE Score of 0 suggest that the person reported no exposure to childhood trauma.
An ACE Score of 10 suggests that the person reported exposure to childhood trauma.
The higher the ACE Score, the greater the likelihood that a person will develop one or more of the following health problems: ischemic heart disease, cancer, chronic bronchitis or emphysema, hepatitis or jaundice skeletal fractures, diabetes, smoking, sexually transmitted diseases , depression, etc.Measure administered to determine emotional, physical, and sexual abuse; emotional and physical neglect; and growing up with domestic violence, parental marital discord, substance abuse, mental illness, and incarceration of a household member experienced during the first 18 years of life
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Baseline and 6 months after baseline
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Research skills & Orientation Toward Research
Time Frame: Baseline and 17 weeks after baseline
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Youth report on the extent to which they know how to use certain research skills and whether they believe that research skills can be useful for community change.
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Baseline and 17 weeks after baseline
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Leadership Skills
Time Frame: Baseline and 17 weeks after baseline
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Youth report on the extent to which they believe they possess certain leadership skills.
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Baseline and 17 weeks after baseline
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Orientation Toward Leadership
Time Frame: Baseline and 17 weeks after baseline
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Youth report on how much they agree that they have the capacity and responsibility to engage in leadership behaviors.
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Baseline and 17 weeks after baseline
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Ethnic-Racial Identity
Time Frame: Baseline and 17 weeks after baseline
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Youth report on their own views about being a member of their ethnic-racial group, how central their ethnic-racial group membership is to their identity, and how they think others view people of their ethnic-racial group.
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Baseline and 17 weeks after baseline
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Social and Emotional Skills
Time Frame: Baseline and 17 weeks after baseline
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Youth report on how easy or difficult it is for them to engage in certain positive social and emotional behaviors.
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Baseline and 17 weeks after baseline
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Involvement in Youth Oriented Activities
Time Frame: Baseline and 17 weeks after baseline
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Youth report their participation and frequency of participation in 25 types of youth-oriented activities at school or in the community.
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Baseline and 17 weeks after baseline
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Satisfaction & Experiences in the Youth Voices Program
Time Frame: Baseline and 17 weeks after baseline
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Youth report their overall satisfaction, perception, and important experiences from participating in the Youth Voices program and working together in a group.
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Baseline and 17 weeks after baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Terri Sullivan, PhD, Virginia Commonwealth University
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)
February 16, 2022
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
March 1, 2026
Study Registration Dates
First Submitted
December 4, 2023
First Submitted That Met QC Criteria
December 18, 2023
First Posted (Estimated)
December 19, 2023
Study Record Updates
Last Update Posted (Estimated)
December 19, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- HM20023324
- 5U01CE003379 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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