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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06176300
Other study ID # HM20023324
Secondary ID 5U01CE003379
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 16, 2022
Est. completion date March 2026

Study information

Verified date December 2023
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 3390
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PAR - the SEED Method
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 Voices
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 intervention
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.

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (2)

Lead Sponsor Collaborator
Virginia Commonwealth University Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reactive-Proactive Aggression Questionnaire (RPQ) 23 item measures of aggression and antisocial behavior Baseline and 6 months after baseline
Primary 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
Primary Firearm Aggression Questionnaire (FAQ) Self-report assessments of violence involving firearms Baseline and 6 months after baseline
Primary Gun Violence Questionnaire (GVQ) Self-report assessments of violence involving firearms Baseline and 6 months after baseline
Primary 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
Primary Youth Dating Violence Questionnaire (YDVQ) 21 item measure that assesses youth dating violence perpetration Baseline and 6 months after baseline
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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. Baseline and 6 months after baseline
Secondary 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 Baseline and 6 months after baseline
Secondary 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 Baseline and 6 months after baseline
Secondary 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. Baseline and 17 weeks after baseline
Secondary Leadership Skills Youth report on the extent to which they believe they possess certain leadership skills. Baseline and 17 weeks after baseline
Secondary Orientation Toward Leadership Youth report on how much they agree that they have the capacity and responsibility to engage in leadership behaviors. Baseline and 17 weeks after baseline
Secondary 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. Baseline and 17 weeks after baseline
Secondary Social and Emotional Skills Youth report on how easy or difficult it is for them to engage in certain positive social and emotional behaviors. Baseline and 17 weeks after baseline
Secondary 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. Baseline and 17 weeks after baseline
Secondary 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. Baseline and 17 weeks after baseline
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