Depression, AnxietyEarly Phase 1BYMNCT03804242
Black Youth M.A.T.T.E.R: Positive Youth Development Group Intervention
A Early Phase 1 study testing Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and Resilience in people with Depression, Anxiety, run by Children's Hospital Los Angeles.
Trial summary
One in three Black boys born today in the United States will be incarcerated at some point in their lifetime, compared to one in 17 White boys. Black males are more likely to be arrested, convicted, and given unfair sentences. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and Resilience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Aug 2020
- Phase
- Early Phase 1
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Black adolescents attending Youth Justice Coalition Free LA High School who have been suspended or expelled from their respective schools due to behavioral problems
Who cannot join
- Active psychosis or suicidal ideation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Controlled Trial of a Positive Youth Development Group
One in three Black boys born today in the United States will be incarcerated at some point in their lifetime, compared to one in 17 White boys. Black males are more likely to be arrested, convicted, and given unfair sentences. Black youth comprise of 16% of the Nation's public schools, but account for 32% of suspended students. For over 30 years, research has consistently highlighted the disproportionately severe disciplinary practices used with Black male students.Consistent research demonstrates that students who are suspended or expelled tend to drop out of school and/or become incarcerated in a juvenile detention center. Black students may relate their racial-ethnic identity, such as their understanding of their race and ethnicity, to academic success. Moreover, their attitudes may result from the expectation of their teachers. It is imperative that advocates devoted to positive youth development intervene to this issue negatively affecting the well-being of Black youth. Under the mentorship of Caitlin Sayegh, Ph.D., postdoctoral fellow Tierra Ellis, Ph.D., has developed a 9-session group intervention called Black Youth M.A.T.T.E.R. (BYM), which aims to debunk mental health stigma, help children shift their cognitive distortions about education, and normalize their experiences through group activities, while introducing them to advocacy and self-empowerment. This intervention may decrease mental health symptoms, increase motivation to approach goal-oriented outcomes, and reverse internalized beliefs and attitudes which may foster more positive perceptions related to school.
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and Resilience
- Keywords
- positive youth development, school-to-prison pipeline, mental health stigma, help-seeking, identity
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and ResilienceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Black Youth M.A.T.T.E.R. | Experimental | 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. Receives: Behavioral: Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and Resilience |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in depressive symptoms and anxiety symptoms
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.
Measured: 61 weeks
Change in trauma symptoms
Trauma Symptom Checklist for Children: Examining Posttraumatic Stress T-score (ranging from 26 to >80), where higher scores indicated greater PTSD symptoms.
Measured: 61 weeks
Change in Youth Reporting Substance Use
Youth Risk Behavior Survey. We will examine dichotomous use of tobacco, alcohol, cannabis, and other drugs
Measured: 61 weeks
Secondary outcomes (2)
Change in Resiliency
Resiliency Scale; range from 0 to 14 with higher scores representing more resiliency
Measured: 61 weeks
Change in Levels of Help-Seeking
Attitudes Toward Seeking Professional Help; scores range from 0 to 30 with higher scores indicated more positive views of help-seeking
Measured: 61 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study startApr 2019 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- More trials run by Children's Hospital Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled pilot trial of intervention versus usual care
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin Sayegh, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804242
- Sponsor's protocol ID
- APP-18-07635
- Acronym
- BYM
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Positive Youth Development Group
- ClinicalTrials.gov ID
- NCT03804242
- Acronym / sponsor ID
- BYM / APP-18-07635
- Conditions
- Depression, Anxiety
- Keywords
- positive youth development, school-to-prison pipeline, mental health stigma, help-seeking, identity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- Apr 2019 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
One in three Black boys born today in the United States will be incarcerated at some point in their lifetime, compared to one in 17 White boys. Black males are more likely to be arrested, convicted, and given unfair sentences. Black youth comprise of 16% of the Nation's public schools, but account for 32% of suspended students. For over 30 years, research has consistently highlighted the disproportionately severe disciplinary practices used with Black male students.Consistent research demonstrates that students who are suspended or expelled tend to drop out of school and/or become incarcerated in a juvenile detention center. Black students may relate their racial-ethnic identity, such as their understanding of their race and ethnicity, to academic success. Moreover, their attitudes may result from the expectation of their teachers. It is imperative that advocates devoted to positive youth development intervene to this issue negatively affecting the well-being of Black youth. Under the mentorship of Caitlin Sayegh, Ph.D., postdoctoral fellow Tierra Ellis, Ph.D., has developed a 9-session group intervention called Black Youth M.A.T.T.E.R. (BYM), which aims to debunk mental health stigma, help children shift their cognitive distortions about education, and normalize their experiences through group activities, while introducing them to advocacy and self-empowerment. This intervention may decrease mental health symptoms, increase motivation to approach goal-oriented outcomes, and reverse internalized beliefs and attitudes which may foster more positive perceptions related to school.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled pilot trial of intervention versus usual care
| Arm | Type | Receives |
|---|---|---|
| Black Youth M.A.T.T.E.R. | Experimental | Behavioral: Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and ResilienceThe 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. |
| Usual Care | No intervention | –All participants already participate in Youth Justice Coalition's Free LA High School. Those in control condition will participate in educational activities as usual. |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Black adolescents attending Youth Justice Coalition Free LA High School who have been suspended or expelled from their respective schools due to behavioral problems
Key exclusion criteria (1 listed)
- Active psychosis or suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and ResilienceThis 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. | Behavioural | Black Youth M.A.T.T.E.R. |
Primary outcome
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.
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.
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
2 secondary outcomes
Change in Resiliency
Time frame: 61 weeks
Change in Levels of Help-Seeking
Time frame: 61 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and Resilience in people with Depression, Anxiety, run by Children's Hospital Los Angeles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caitlin S Sayegh, Ph.D. (323-361-7748, cssayegh@chla.usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depressive symptoms and anxiety symptoms (time frame: 61 weeks). The study lists 3 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 15 Jan 2019.