ViolenceNCT06176300
Evaluation of Violence Prevention Strategies to Prevent and Reduce Community Levels of Youth Violence
A study testing PAR - the SEED Method, PAR-Youth Voices and Emerging Leaders hospital-based intervention in people with Violence and Exposure to Violent Event, run by Virginia Commonwealth University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Violence, Exposure to Violent Event, Adolescent Behavior
- What is being tested?
- PAR - the SEED Method, PAR-Youth Voices and Emerging Leaders hospital-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,390 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2022to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
- 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
Who cannot join
- 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 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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.
Read the 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.
- Conditions
- Violence, Exposure to Violent Event, Adolescent Behavior
- Being tested
- PAR - the SEED Method, PAR-Youth Voices, Emerging Leaders hospital-based intervention
- Medical subject headings
- Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAR - the SEED MethodBehavioural
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.
PAR-Youth VoicesBehavioural
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 hospital-based interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Community A | Experimental | Not described Receives: Behavioral: PAR - the SEED Method; Behavioral: PAR-Youth Voices; Behavioral: Emerging Leaders hospital-based intervention |
| Community B | Experimental | Not described Receives: Behavioral: PAR - the SEED Method; Behavioral: PAR-Youth Voices; Behavioral: Emerging Leaders hospital-based intervention |
| Community C | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive-Proactive Aggression Questionnaire (RPQ)
23 item measures of aggression and antisocial behavior
Measured: 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
Measured: Baseline and 6 months after baseline
Firearm Aggression Questionnaire (FAQ)
Self-report assessments of violence involving firearms
Measured: Baseline and 6 months after baseline
Gun Violence Questionnaire (GVQ)
Self-report assessments of violence involving firearms
Measured: 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
Measured: Baseline and 6 months after baseline
Youth Dating Violence Questionnaire (YDVQ)
21 item measure that assesses youth dating violence perpetration
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 17 weeks later
Secondary outcomes (10)
Developmental Assets Profile (DAP)
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.
Measured: Baseline and 6 months after baseline
Behavior Assessment System for Children (BASC)
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
Measured: Baseline and 6 months after baseline
Adverse Childhood Experiences (ACES)
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
Measured: Baseline and 6 months after baseline
Research skills & Orientation Toward Research
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.
Measured: Baseline and 17 weeks after baseline
Leadership Skills
Youth report on the extent to which they believe they possess certain leadership skills.
Measured: Baseline and 17 weeks after baseline
Orientation Toward Leadership
Youth report on how much they agree that they have the capacity and responsibility to engage in leadership behaviors.
Measured: Baseline and 17 weeks after baseline
Ethnic-Racial Identity
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.
Measured: Baseline and 17 weeks after baseline
Social and Emotional Skills
Youth report on how easy or difficult it is for them to engage in certain positive social and emotional behaviors.
Measured: Baseline and 17 weeks after baseline
Involvement in Youth Oriented Activities
Youth report their participation and frequency of participation in 25 types of youth-oriented activities at school or in the community.
Measured: Baseline and 17 weeks after baseline
Satisfaction & Experiences in the Youth Voices Program
Youth report their overall satisfaction, perception, and important experiences from participating in the Youth Voices program and working together in a group.
Measured: Baseline and 17 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start16 Feb 2022
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ViolenceStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3,390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Terri Sullivan, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06176300
- Sponsor's protocol ID
- HM20023324
- Other IDs
- 5U01CE003379
- Status last verified
- Oct 2026
- First submitted
- 4 Dec 2023
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VCU Healthy Communities for Youth: Evaluation of Violence Prevention Strategies to Prevent and Reduce Community Levels of Youth Violence
- ClinicalTrials.gov ID
- NCT06176300
- Acronym / sponsor ID
- HM20023324
- Conditions
- Violence, Exposure to Violent Event, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 3,390 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 19 Dec 2023 (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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Community A | Experimental | Behavioral: PAR - the SEED Method, Behavioral: PAR-Youth Voices, Behavioral: Emerging Leaders hospital-based intervention |
| Community B | Experimental | Behavioral: PAR - the SEED Method, Behavioral: PAR-Youth Voices, Behavioral: Emerging Leaders hospital-based intervention |
| Community C | No intervention | – |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- Those who do not meet the inclusion criteria
- Those with limited English proficiency
Key exclusion criteria (7 listed)
- Youth younger than 14 and older than 24 will be excluded.
- Prisoners will be excluded.
- Those living outside our community boundaries will be excluded.
- Youth in grades below 9th
- Youth who have graduated from high school
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 |
|---|---|---|
| PAR - the SEED MethodThe 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. | Behavioural | Community A, Community B |
| PAR-Youth VoicesYouth 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. | Behavioural | Community A, Community B |
| Emerging Leaders hospital-based interventionEmerging 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. | Behavioural | Community A, Community B |
Primary outcome
Reactive-Proactive Aggression Questionnaire (RPQ)
Time frame: Baseline and 6 months after baseline
23 item measures of aggression and antisocial behavior
Beliefs About Aggression and Alternatives (BAA)
Time frame: Baseline and 6 months after baseline
12 item measures that uses a 4-point Likert scale to assess agreement and disagreement on items involving the use of aggression
Firearm Aggression Questionnaire (FAQ)
Time frame: Baseline and 6 months after baseline
Self-report assessments of violence involving firearms
Gun Violence Questionnaire (GVQ)
Time frame: Baseline and 6 months after baseline
Self-report assessments of violence involving firearms
Peer Pressure for Fighting (PPF)
Time frame: Baseline and 6 months after baseline
A questionnaire about peer pressure for fighting is a subscale derived from the Problem Behavior Frequency Scales-Adolescent Report
Youth Dating Violence Questionnaire (YDVQ)
Time frame: Baseline and 6 months after baseline
21 item measure that assesses youth dating violence perpetration
Engagement in Community Advocacy
Time frame: Baseline and 17 weeks later
Youth report on the frequency with which they have engaged in these specified community advocacy activities.
Orientation to Community Advocacy
Time frame: Baseline and 17 weeks later
Youth report on how much they agree with statements that indicate and orientation of working cooperatively with others for community advocacy and change.
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.
Civic Engagement
Time frame: Baseline and 17 weeks later
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.
Critical Consciousness
Time frame: Baseline and 17 weeks later
Youth report on how much they agree with statements that reflect the awareness, perception, and reflection on societal experiences of inequality.
10 secondary outcomes
Developmental Assets Profile (DAP)
Time frame: Baseline and 6 months after baseline
Behavior Assessment System for Children (BASC)
Time frame: Baseline and 6 months after baseline
Adverse Childhood Experiences (ACES)
Time frame: Baseline and 6 months after baseline
Research skills & Orientation Toward Research
Time frame: Baseline and 17 weeks after baseline
Leadership Skills
Time frame: Baseline and 17 weeks after baseline
Orientation Toward Leadership
Time frame: Baseline and 17 weeks after baseline
Ethnic-Racial Identity
Time frame: Baseline and 17 weeks after baseline
Social and Emotional Skills
Time frame: Baseline and 17 weeks after baseline
Involvement in Youth Oriented Activities
Time frame: Baseline and 17 weeks after baseline
Satisfaction & Experiences in the Youth Voices Program
Time frame: Baseline and 17 weeks after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Violence
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
Not yet recruiting
A Patient Navigation Trial for Housing and Health (PATHH)
Housing Instability, Health and Social Services
Active, not recruiting
Supportive Hospital-Based Intervention for Firearm Trauma
Gun Violence Prevention, Adolescent Behavior
Active, not recruiting
What Works to Prevent Violence Against Women and Girls in Madagascar
Comprehensive Sexual Education
Not yet recruiting
BEAR for Women Who Have Experienced Sexual Assault and Have Suicidal Thoughts
Sexual Assault and Rape, Suicidal Thoughts
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.
Terri Sullivan, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAR - the SEED Method, PAR-Youth Voices and Emerging Leaders hospital-based intervention in people with Violence and Exposure to Violent Event, run by Virginia Commonwealth University 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 14 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 9 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Reactive-Proactive Aggression Questionnaire (RPQ) (time frame: Baseline and 6 months after baseline). The study lists 11 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 9 Oct 2026.