A Multi-level Approach to Violence Prevention Among African American Adolescents

NCT ID: NCT03615716

Last Updated: 2019-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-11

Study Completion Date

2019-06-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The overall goal of this study is to advance the science of youth violence prevention and the social determinants of health by using a community-driven approach to implement a comprehensive intervention. The objective of the proposed project is to assess the feasibility, acceptability, and preliminary efficacy of an innovative, multi-level intervention that promotes adolescent protective factors and reduces risk behaviors among African American youth residing in Birmingham. Alabama.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Perceived neighborhood violence, hearing about violence in one's community, and being a victim of violence contributes to adverse psychological conditions such as anxiety, depression, and stress, which may have cascading negative effects physically and be the start of a vicious cycle. Among children, the prevalence of neighborhood violent crime is linked to symptoms of post-traumatic stress disorder (PTSD), aggressive behavior, school attendance problems, sexual risk taking, and the use of alcohol, tobacco, and other drugs.

Since childhood is a critical and fragile time with respect to developmental trajectories and relationship building, it is an important time to intervene. Previous research used a deficit model focusing on risks as opposed to an asset model, which focuses on protective factors related to prosocial and positive traits. Building the protective factors (e.g., involvement in prosocial activities, intolerant attitude toward deviance, connectedness to adults outside the family) of youth can promote well-being and reduce the risks of negative outcomes. Social-emotional learning (SEL) programming targeting adolescents is thus becoming increasingly funded because of its documented success, such as higher levels of prosocial behavior, more favorable attitudes toward school and others, and better academic achievement.

The overall goal of this study is to advance the science of youth violence prevention and the social determinants of health by using a community-driven approach to implement a comprehensive intervention. The objective of the proposed project is to assess the feasibility, acceptability, and preliminary efficacy of an innovative, multi-level intervention that promotes adolescent protective factors and reduces risk behaviors among African American youth residing in Birmingham. Alabama. According to data from the FBI's 2015 Uniform Crime Report, Birmingham is ranked as the nation's 3rd most violent city with high levels of violent crime occurring in the a neighborhood located in Northeast Birmingham, Alabama. By partnering with national and local community partners, this study proposes to design a comprehensive intervention that integrates an evidence-based, individual-level SEL program with a relationship-level mentoring component and a community-level environmental improvement component. The proposed pilot project is building on recently established community relationships. Through community capacity development funds, the investigators helped establish a community coalition in Spring of 2016 to identify and address the underlying causes of health disparities in the community. The coalition has identified violence and safety as issues that community members most desire to be addressed and has recommended strategies, such as establishing a mentoring program, providing activities for children, and organizing community improvement activities. The proposed project addresses several of these issues and our community partners have expressed enthusiastic support of the project.

The proposed project will be achieved through the following specific aims:

Aim 1: Conduct a 4-month multi-level youth violence prevention intervention that includes an individual-level social-emotional learning program with a relationship-level mentoring component and a community-level environmental improvement component. The intervention will include 20 African American male adolescents residing in a community in Birmingham, AL.

Aim 2: Assess the feasibility and acceptability of the multi-level intervention.

1. Feasibility and Acceptability (Primary Outcome): Detailed process data will be collected to assess recruitment, retention, and acceptance. It is hypothesized that 20 African American adolescents (6th-8th grade) will be recruited, \>80% of the participants will be retained, and \>80%will accept the intervention.
2. Efficacy (Secondary Outcome): To determine the effects of the intervention on aggressive behavior and prosocial behavior (protective factors). It is hypothesized that participants will have significantly lower levels of aggressive behavior and higher levels of prosocial behavior.

This study will be a significant contribution to the multi-level violence prevention literature and lay the foundation for a larger study using an experimental design to examine effects of a violence prevention intervention on individual and community health and well-being. In addition, lessons learned from this project can serve as a model to address violence prevention in similar inner-city communities in the United States.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Violence in Adolescence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study has 2 groups of participants. Only one group, middle school boys (N=20), will receive the intervention. But, pre- and post-assessments will be conducted with 2 groups: (1) boys, (2) caregivers. Caregivers (N=20) will give their perspectives of boys' behavior pre- and post- intervention.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multi-level Violence Prevention Intervention - Boys

A study examining middle school boys who have a high potential of violence based on where they live. This arm will measure outcomes in the boys. as the result of the intervention, from the perspectives of the boys.

Group Type EXPERIMENTAL

Multi-level Violence Prevention Intervention - Boys

Intervention Type BEHAVIORAL

Comprehensive, Multi-level Violence Prevention Intervention. The intervention consists of three components: (1) a 15-week after-school program, (2) group mentoring, and (3) community enhancement activities. Adolescents and mentors will attend a 2-hour weekly session at a community center, and will conduct up to four community enhancement activities. At the end of the program, a graduation celebration will be planned, and parents/guardians and stakeholders (e.g., coalition members) will be invited.

Multi-level Violence Prevention Intervention - Caregivers

In this study examining middle school boys who have a high potential of violence based on where they live, this arm will measure caregivers' perspectives of the boys ' outcomes. Caregivers will be surveyed pre-intervention and 4- and 6-month post intervention to explore the impact of the boys' intervention.

Group Type EXPERIMENTAL

Multi-level Violence Prevention Intervention - Caregivers

Intervention Type BEHAVIORAL

This is arm is measuring the Multi-level Violence Prevention Intervention that is administered to the boys, from the perspectives of their caregivers. The caregivers themselves will not receive an intervention, but their perspectives of the impact on the interventions on the boys will be examined

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multi-level Violence Prevention Intervention - Boys

Comprehensive, Multi-level Violence Prevention Intervention. The intervention consists of three components: (1) a 15-week after-school program, (2) group mentoring, and (3) community enhancement activities. Adolescents and mentors will attend a 2-hour weekly session at a community center, and will conduct up to four community enhancement activities. At the end of the program, a graduation celebration will be planned, and parents/guardians and stakeholders (e.g., coalition members) will be invited.

Intervention Type BEHAVIORAL

Multi-level Violence Prevention Intervention - Caregivers

This is arm is measuring the Multi-level Violence Prevention Intervention that is administered to the boys, from the perspectives of their caregivers. The caregivers themselves will not receive an intervention, but their perspectives of the impact on the interventions on the boys will be examined

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male
* Identify as African American or Black
* aged 11-14 years at the time of the study enrollment
* Reside in the targeted community
* Be able to meet after school once a week for 4-months.


* Identify as the primary caregiver of a boy enrolled in the study

Exclusion Criteria

* Not English speaking


* Not English speaking
Minimum Eligible Age

11 Years

Maximum Eligible Age

14 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yu-Mei Schoenberger

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yu-Mei Schoenberger, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRB-300000551

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.