- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03615716
A Multi-level Approach to Violence Prevention Among African American Adolescents
A Multi-level Approach to Violence Prevention Among African American
Study Overview
Status
Conditions
Detailed Description
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.
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35209
- The University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Boys 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.
Boys Exclusion Criteria:
- Not English speaking
Caregivers Inclusion Criteria:
- Identify as the primary caregiver of a boy enrolled in the study
Caregivers Exclusion Criteria:
- Not English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Experimental: 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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate behavior using the Strengths and Difficulties Questionnaire
Time Frame: At baseline
|
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
Time Frame: From baseline through 4 months
|
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
Time Frame: From baseline through 6 months
|
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
Time Frame: baseline
|
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
Time Frame: 4 months
|
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
Time Frame: 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Satisfaction
Time Frame: 4 months
|
6-item intervention satisfaction measure
|
4 months
|
|
Participant satisfaction with mentors
Time Frame: 4 months
|
adaptation of a satisfaction with patient navigator questionnaire
|
4 months
|
|
Utilization - Sessions
Time Frame: 4 months
|
number of sessions attended
|
4 months
|
|
Utilization - community service activities
Time Frame: 4 months
|
number of community activities attended
|
4 months
|
|
Utilization - time with mentor
Time Frame: 4 months
|
total minutes spent with mentor
|
4 months
|
|
Sense of Belonging Scale
Time Frame: baseline
|
5-item 5-point likert scale measures sense of belonging in the program (i.e., connected, committed, supported, accepted).
Validated among ages 9-19 (α=.93).
|
baseline
|
|
Sense of Belonging Scale
Time Frame: 4 months
|
5-item 5-point likert scale measures sense of belonging in the program (i.e., connected, committed, supported, accepted).
Validated among ages 9-19 (α=.93).
|
4 months
|
|
Sense of Belonging Scale
Time Frame: 6 months
|
5-item 5-point likert scale measures sense of belonging in the program (i.e., connected, committed, supported, accepted).
Validated among ages 9-19 (α=.93).
|
6 months
|
|
School Safety
Time Frame: baseline
|
1-item 5-point likert scale assessing agreement with the statement, "I feel safe at my school" (strongly agree to strongly disagree).
Has been shown to have validity and reliability in terms of both predictors (e.g., sociodemographics) and predicting outcomes (e.g., well-being).
|
baseline
|
|
School Safety
Time Frame: 4 months
|
1-item 5-point likert scale assessing agreement with the statement, "I feel safe at my school" (strongly agree to strongly disagree).
Has been shown to have validity and reliability in terms of both predictors (e.g., sociodemographics) and predicting outcomes (e.g., well-being).
|
4 months
|
|
School Safety
Time Frame: 6 months
|
1-item 5-point likert scale assessing agreement with the statement, "I feel safe at my school" (strongly agree to strongly disagree).
Has been shown to have validity and reliability in terms of both predictors (e.g., sociodemographics) and predicting outcomes (e.g., well-being).
|
6 months
|
|
Neighborhood safety
Time Frame: baseline
|
4-item 5-point likert scale includes items such as "It's safe to walk around my neighborhood" and "I'm scared of people in my neighborhood" with higher scores indicating greater neighborhood safety (α=.77).
|
baseline
|
|
Neighborhood safety
Time Frame: 4 months
|
4-item 5-point likert scale includes items such as "It's safe to walk around my neighborhood" and "I'm scared of people in my neighborhood" with higher scores indicating greater neighborhood safety (α=.77).
|
4 months
|
|
Neighborhood safety
Time Frame: 6 months
|
4-item 5-point likert scale includes items such as "It's safe to walk around my neighborhood" and "I'm scared of people in my neighborhood" with higher scores indicating greater neighborhood safety (α=.77).
|
6 months
|
|
Neighborhood Cohesion
Time Frame: baseline
|
5-item 5-point likert scale measuring how much they agree with statements regarding their neighborhood and neighbors such as "people in this neighborhood can be trusted," "people in this neighborhood do not share the same values," and "there are people I can count on in this neighborhood."
|
baseline
|
|
Neighborhood Cohesion
Time Frame: 4 months
|
5-item 5-point likert scale measuring how much they agree with statements regarding their neighborhood and neighbors such as "people in this neighborhood can be trusted," "people in this neighborhood do not share the same values," and "there are people I can count on in this neighborhood."
|
4 months
|
|
Neighborhood Cohesion
Time Frame: 6 months
|
5-item 5-point likert scale measuring how much they agree with statements regarding their neighborhood and neighbors such as "people in this neighborhood can be trusted," "people in this neighborhood do not share the same values," and "there are people I can count on in this neighborhood."
|
6 months
|
|
Family Cohesion
Time Frame: baseline
|
12-item subscale contains items related to family communication and closeness.
|
baseline
|
|
Family Cohesion
Time Frame: 4 months
|
12-item subscale contains items related to family communication and closeness.
|
4 months
|
|
Family Cohesion
Time Frame: 6 months
|
12-item subscale contains items related to family communication and closeness.
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yu-Mei Schoenberger, PhD, The University of Alabama at Birmingham
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-300000551
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Violence in Adolescence
-
University of PittsburghCompletedViolence in Adolescence | Domestic ViolenceUnited States
-
Virginia Commonwealth UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingViolence in AdolescenceUnited States
-
Virginia Commonwealth UniversityCenters for Disease Control and PreventionTerminatedViolence in AdolescenceUnited States
-
University of AlicanteEuropean CommissionCompleted
-
University of MichiganCenters for Disease Control and PreventionCompletedViolence in AdolescenceUnited States
-
University of PittsburghCenters for Disease Control and PreventionRecruitingViolence, Domestic | Violence in Adolescence | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Social Cohesion | Violence, Structural | Community ViolenceUnited States
-
University of PittsburghEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedCoping Skills | Violence in Adolescence | Adolescent Behavior | Social InteractionUnited States
-
University of PittsburghCenters for Disease Control and PreventionCompletedViolence, Domestic | Coping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Group, Peer | Emotional Abuse | Communication, PersonalUnited States
-
University of PittsburghThe Grable Foundation; Department Human Services, Pennsylvania; Fisa FoundationCompletedViolence, Domestic | Coping Skills | Violence in Adolescence | Adolescent Behavior | Violence, Sexual | Violence, Physical | Violence, Non-accidental | Group, Peer | Emotional Abuse | Communication, PersonalUnited States
-
University of Colorado, Colorado SpringsUniversity of Nebraska LincolnRecruitingAlcohol Drinking | Violence in AdolescenceUnited States
Clinical Trials on Multi-level Violence Prevention Intervention - Boys
-
Inonu UniversityCompleted
-
US Department of Veterans AffairsCompletedSubstance-related Disorders | ViolenceUnited States
-
Emory UniversityNational AIDS Research Institute, IndiaCompleted
-
London School of Hygiene and Tropical MedicineInternational Rescue CommitteeCompletedDomestic ViolenceCôte D'Ivoire
-
The University of Hong KongCompleted
-
Aomori University of Health and WelfareCompleted
-
Chiba UniversityNovo Nordisk A/S; Delivery Associates; The Behavioural Insights TeamNot yet recruitingObesity | Physical Activity | Childhood Obesity | Nutrition | Quality of Life (QOL)Japan
-
Karnataka Health Promotion TrustLondon School of Hygiene and Tropical Medicine; University of ManitobaCompletedHIV | Violence | Sexual BehaviourIndia
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH); St. Jude...Not yet recruitingPediatric CancerUnited States
-
Fred Hutchinson Cancer CenterNational Institute on Minority Health and Health Disparities (NIMHD)CompletedObesity, ChildhoodUnited States