NCT03615716

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

February 11, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2019

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

July 9, 2018

Last Update Submit

August 1, 2019

Conditions

Keywords

violenceadolescence

Outcome Measures

Primary Outcomes (6)

  • Evaluate behavior using the Strengths and Difficulties Questionnaire

    25-item self-report Strengths and Difficulties Questionnaire (SDQ) validated for ages 11-16. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (α=.73)

    At baseline

  • Evaluate behavior using the Strengths and Difficulties Questionnaire

    25-item self-report Strengths and Difficulties Questionnaire (SDQ) validated for ages 11-16. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (α=.73)

    From baseline through 4 months

  • Evaluate behavior using the Strengths and Difficulties Questionnaire

    25-item self-report Strengths and Difficulties Questionnaire (SDQ) validated for ages 11-16. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior (α=.73)

    From baseline through 6 months

  • Child aggressive behavior and prosocial skills - for parent/guardian to complete

    25-item parent Strengths and Difficulties Questionnaire (SDQ) measures child's behavior from parent perspective. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.

    baseline

  • Child aggressive behavior and prosocial skills - for parent/guardian to complete

    25-item parent Strengths and Difficulties Questionnaire (SDQ) measures child's behavior from parent perspective. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.

    4 months

  • Child aggressive behavior and prosocial skills - for parent/guardian to complete

    25-item parent Strengths and Difficulties Questionnaire (SDQ) measures child's behavior from parent perspective. It is divided into 5 scales: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior.

    6 months

Secondary Outcomes (20)

  • Perceived Satisfaction

    4 months

  • Participant satisfaction with mentors

    4 months

  • Utilization - Sessions

    4 months

  • Utilization - community service activities

    4 months

  • Utilization - time with mentor

    4 months

  • +15 more secondary outcomes

Study Arms (2)

Multi-level Violence Prevention Intervention - Boys

EXPERIMENTAL

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.

Behavioral: Multi-level Violence Prevention Intervention - Boys

Multi-level Violence Prevention Intervention - Caregivers

EXPERIMENTAL

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.

Behavioral: Multi-level Violence Prevention Intervention - Caregivers

Interventions

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 - Boys

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

Multi-level Violence Prevention Intervention - Caregivers

Eligibility Criteria

Age11 Years - 14 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Not English speaking
  • Identify as the primary caregiver of a boy enrolled in the study
  • Not English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Alabama at Birmingham

Birmingham, Alabama, 35209, United States

Location

Study Officials

  • Yu-Mei Schoenberger, PhD

    The University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 9, 2018

First Posted

August 6, 2018

Study Start

February 11, 2019

Primary Completion

June 12, 2019

Study Completion

June 12, 2019

Last Updated

August 5, 2019

Record last verified: 2019-08

Locations