- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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.
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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.
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Sin intervención: 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in depressive symptoms and anxiety symptoms
Periodo de tiempo: 61 weeks
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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.
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61 weeks
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Change in trauma symptoms
Periodo de tiempo: 61 weeks
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Trauma Symptom Checklist for Children: Examining Posttraumatic Stress T-score (ranging from 26 to >80), where higher scores indicated greater PTSD symptoms.
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61 weeks
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Change in Youth Reporting Substance Use
Periodo de tiempo: 61 weeks
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Youth Risk Behavior Survey.
We will examine dichotomous use of tobacco, alcohol, cannabis, and other drugs
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61 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in Resiliency
Periodo de tiempo: 61 weeks
|
Resiliency Scale; range from 0 to 14 with higher scores representing more resiliency
|
61 weeks
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Change in Levels of Help-Seeking
Periodo de tiempo: 61 weeks
|
Attitudes Toward Seeking Professional Help; scores range from 0 to 30 with higher scores indicated more positive views of help-seeking
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61 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Anticipado)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- APP-18-07635
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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