- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03804242
Black Youth M.A.T.T.E.R: Positive Youth Development Group Intervention (BYM)
A Randomized Controlled Trial of a Positive Youth Development Group
Study Overview
Status
Conditions
Detailed Description
The proposed study is a randomized control trial mixed-methods pilot study of BYM. We aim to finalize the intervention protocol, assess feasibility and acceptability of the intervention, and evaluate the potential impact of BYM on pilot participants. The mixed-methods research design approach will be used within a single study for the collection, analyzing, and merging of qualitative and quantitative data. The purpose of a convergent parallel mixed methods research design is to simultaneously collect qualitative and quantitative data for a more comprehensive analysis.
Research Questions: (1) What do Black adolescents and other community stakeholders perceive as the most effective approaches for the BYM project? (2) What are BYM participants' perceptions of the intervention? (3) Is there a decrease in mental health symptoms (e.g., depression, anxiety, trauma) for BYM participants? (3) Is there an increase in resiliency for BYM participants? (4) Is there an increase in positive attitudes toward seeking mental health treatment for BYM participants? (5) Is there a difference in motivation to approach goal-oriented outcomes for BYM participants? (6) Is there an increase in perceived positive self-concept for BYM participants? (7) Is there a decrease in risk behaviors for BYM participants? Intervention Description: The session topics are as follows: (1) Debunking the Stigma of Mental Health in the Black Community, (2) School to Prison Pipeline, (3) Achievement Gap, (4) Cultural Barrier that Black Students Experience with Teachers, (5) Trauma 101, (6) Trauma 102, (7) Actions of Today, Blueprints for Tomorrow: Youth Organizing to Transform Education film, (8) My Voice Will Be Heard (Part I), and (9) My Voice Will Be Heard (Part II). The intervention will be conducted in 2-hour weekly group sessions.
Study Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Caitlin S Sayegh, Ph.D.
- Phone Number: 323-361-7748
- Email: cssayegh@chla.usc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Black adolescents attending Youth Justice Coalition Free LA High School who have been suspended or expelled from their respective schools due to behavioral problems
Exclusion Criteria:
- Active psychosis or suicidal ideation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Black Youth M.A.T.T.E.R.
The session topics are as follows: (1) Debunking the Stigma of Mental Health in the Black Community, (2) School to Prison Pipeline, (3) Achievement Gap, (4) Cultural Barrier that Black Students Experience with Teachers, (5) Trauma 101, (6) Trauma 102, (7) Actions of Today, Blueprints for Tomorrow: Youth Organizing to Transform Education film, (8) My Voice Will Be Heard (Part I), and (9) My Voice Will Be Heard (Part II).
The intervention will be conducted in 2-hour weekly group sessions.
|
This is a group psychoeducational and positive youth development intervention for students who have been expelled from school and are now enrolled in a specialized school at Youth Justice Coalition.
|
No Intervention: Usual Care
All participants already participate in Youth Justice Coalition's Free LA High School.
Those in control condition will participate in educational activities as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in depressive symptoms and anxiety symptoms
Time Frame: 61 weeks
|
Revised Children's Anxiety and Depression Scale.
The T-score related to Total Anxiety and Depression score will be examined (ranging from 26 to >80).
Higher scores indicate increased depression and anxiety symptoms.
|
61 weeks
|
Change in trauma symptoms
Time Frame: 61 weeks
|
Trauma Symptom Checklist for Children: Examining Posttraumatic Stress T-score (ranging from 26 to >80), where higher scores indicated greater PTSD symptoms.
|
61 weeks
|
Change in Youth Reporting Substance Use
Time Frame: 61 weeks
|
Youth Risk Behavior Survey.
We will examine dichotomous use of tobacco, alcohol, cannabis, and other drugs
|
61 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Resiliency
Time Frame: 61 weeks
|
Resiliency Scale; range from 0 to 14 with higher scores representing more resiliency
|
61 weeks
|
Change in Levels of Help-Seeking
Time Frame: 61 weeks
|
Attitudes Toward Seeking Professional Help; scores range from 0 to 30 with higher scores indicated more positive views of help-seeking
|
61 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- APP-18-07635
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.
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