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Violence in AdolescenceNCT03615716

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

A study testing Multi-level Violence Prevention Intervention - Boys and Multi-level Violence Prevention Intervention - Caregivers in people with Violence in Adolescence, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 14 years, men onlyHealthy volunteers can take part
Conditions the study is for
Violence in Adolescence
What is being tested?
Multi-level Violence Prevention Intervention - Boys and Multi-level Violence Prevention Intervention - Caregivers
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
11 Feb 2019to 12 Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

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 11 to 14 years
  • Men only
  • Healthy volunteers accepted
  • Child

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35209

Other trials in United States

About this study

Official title: A Multi-level Approach to Violence Prevention Among African American

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.

Read the 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.

  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.

Being tested
Multi-level Violence Prevention Intervention - Boys, Multi-level Violence Prevention Intervention - Caregivers
Keywords
violence, adolescence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-level Violence Prevention Intervention - BoysBehavioural

    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 - CaregiversBehavioural

    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

Study groups in NCT03615716
Study groupRoleWhat they receive
Multi-level Violence Prevention Intervention - BoysExperimentalA 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.
Receives: Behavioral: Multi-level Violence Prevention Intervention - Boys
Multi-level Violence Prevention Intervention - CaregiversExperimentalIn 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.
Receives: Behavioral: Multi-level Violence Prevention Intervention - Caregivers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: At baseline

  2. 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)

    Measured: From baseline through 4 months

  3. 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)

    Measured: From baseline through 6 months

  4. 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.

    Measured: baseline

  5. 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.

    Measured: 4 months

  6. 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.

    Measured: 6 months

Secondary outcomes (20)
  1. Perceived Satisfaction

    6-item intervention satisfaction measure

    Measured: 4 months

  2. Participant satisfaction with mentors

    adaptation of a satisfaction with patient navigator questionnaire

    Measured: 4 months

  3. Utilization - Sessions

    number of sessions attended

    Measured: 4 months

  4. Utilization - community service activities

    number of community activities attended

    Measured: 4 months

  5. Utilization - time with mentor

    total minutes spent with mentor

    Measured: 4 months

  6. Sense of Belonging Scale

    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).

    Measured: baseline

  7. Sense of Belonging Scale

    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).

    Measured: 4 months

  8. Sense of Belonging Scale

    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).

    Measured: 6 months

  9. School Safety

    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).

    Measured: baseline

  10. School Safety

    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).

    Measured: 4 months

  11. School Safety

    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).

    Measured: 6 months

  12. Neighborhood safety

    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).

    Measured: baseline

  13. Neighborhood safety

    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).

    Measured: 4 months

  14. Neighborhood safety

    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).

    Measured: 6 months

  15. Neighborhood Cohesion

    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."

    Measured: baseline

  16. Neighborhood Cohesion

    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."

    Measured: 4 months

  17. Neighborhood Cohesion

    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."

    Measured: 6 months

  18. Family Cohesion

    12-item subscale contains items related to family communication and closeness.

    Measured: baseline

  19. Family Cohesion

    12-item subscale contains items related to family communication and closeness.

    Measured: 4 months

  20. Family Cohesion

    12-item subscale contains items related to family communication and closeness.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2018
  2. Study start11 Feb 2019
  3. Primary completion12 Jun 2019
  4. Study completion12 Jun 2019

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03615716
Sponsor's protocol ID
IRB-300000551
Status last verified
Aug 2019
First submitted
9 Jul 2018
Last updated
5 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Multi-level Violence Prevention Intervention - Boys and Multi-level Violence Prevention Intervention - Caregivers in people with Violence in Adolescence, run by University of Alabama at Birmingham 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?

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: finished, as of the sponsor's last update on 5 Aug 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Evaluate behavior using the Strengths and Difficulties Questionnaire (time frame: At baseline). The study lists 6 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 5 Aug 2019.

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