- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00071513
Middle School to High School Transition Project: Depression and Substance Abuse Prevention (CAST-T/HSTS)
Middle School to High School Transition Project
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The transition from middle school to high school presents important challenges for adolescents. Programs that enhance personal efficacy and social support resources may prevent at-risk students from developing behaviors that can lead to substance use, academic failure, and depression. This study will implement a skills-based program called Coping and Support Training for the Transition (CAST-T) as a preventive intervention for at-risk students.
At-risk students in eighth grade will be randomly assigned to receive either CAST-T or school as usual. The CAST-T program will initially be delivered in twelve sessions over 6 weeks in the middle school setting. The program includes booster sessions, case management, structured home-based parent education, and support and skills training throughout the transition period. Participants will be assessed from the beginning of eighth grade to the end of ninth grade. Vulnerability to academic problems and depression will be assessed with school records and self-report scale scores.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98195
- University of Washington
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- At-risk for substance abuse, academic failure, and depression
- Enrolled in eighth grade in Seattle Public Schools
- English-speaking
Exclusion Criteria:
- Score above the clinical cutoff on the Youth Self Report Aggressive subscale
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 |
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Experimental: CAST-T/HSTS
The CAST-T/HSTS condition combined the Brief Intervention and 12 school based small group sessions which taught skills to enhance personal control (to manage depression, anger, stress), self-esteem, decision making and interpersonal communications.
HSTS skills groups were held in the spring of 8th grade with 4 one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents also participated in 4 sessions.
HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.
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Skills training small group.
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Comparador activo: Brief Intervention
Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support.
The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents.
Feedback call to parents reviewed concerns and made recommendations for services as needed.
A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.
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Assessment of needs and referral to services as needed.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Short Moods and Feelings Questionnaire (SMFQ)
Periodo de tiempo: Baseline to 18 months
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The Short Moods and Feelings Questionnaire is a 13 item measure of level of self reported depressive symptoms.
Each item in scored on a 3-point Likert scale as follows: "True" (0), "Sometimes" (1), and "Not True" (2) rated within the timeframe of the previous two weeks.
A total score is obtained; scores can range from 0 to 26.
Total scores of 12 or higher may signify that a child/adolescent is suffering from depression.
Higher scores on this scale suggest a worse outcome or greater endorsement of depressive symptoms.
Change is measured based on two time points baseline to the 18 months follow-up assessment.
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Baseline to 18 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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School Attachment
Periodo de tiempo: 18 months
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School attachment measure consisted of 4 items. Item responses range from 0 (unsatisfied, rarely attended, not involved, etc.) to 6 (highly satisfied, regularly attended, very involved, etc). Scores could range from 0 to 36 with higher scores indicating more positive school attachment. Item were: My overall satisfaction with classes was… Overall, how safe did school feel last semester… Overall, how friendly did school feel… How involved were you in school activities… |
18 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Elizabeth McCauley, PhD, University of Washington
- Investigador principal: Ann Vander Stoep, PhD, University of Washington
Publicaciones y enlaces útiles
Publicaciones Generales
- Lyon AR, Ludwig KA, Stoep AV, Gudmundsen G, McCauley E. Patterns and Predictors of Mental Healthcare Utilization in Schools and other Service Sectors among Adolescents at Risk for Depression. School Ment Health. 2013 Aug 1;5(3):10.1007/s12310-012-9097-6. doi: 10.1007/s12310-012-9097-6.
- Banh MK, Crane PK, Rhew I, Gudmundsen G, Stoep AV, Lyon A, McCauley E. Measurement equivalence across racial/ethnic groups of the mood and feelings questionnaire for childhood depression. J Abnorm Child Psychol. 2012 Apr;40(3):353-67. doi: 10.1007/s10802-011-9569-4.
- Rhew IC, Simpson K, Tracy M, Lymp J, McCauley E, Tsuang D, Stoep AV. Criterion validity of the Short Mood and Feelings Questionnaire and one- and two-item depression screens in young adolescents. Child Adolesc Psychiatry Ment Health. 2010 Feb 9;4(1):8. doi: 10.1186/1753-2000-4-8.
- Kuo E, Vander Stoep A, McCauley E, Kernic MA. Cost-effectiveness of a school-based emotional health screening program. J Sch Health. 2009 Jun;79(6):277-85. doi: 10.1111/j.1746-1561.2009.00410.x.
- McCormick E, Thompson K, Stoep AV, McCauley E. The Case for School-Based Depression Screening: Evidence From Established Programs. Rep Emot Behav Disord Youth. 2009 Fall;9(4):91-96.
- Blossom JB, Adrian MC, Stoep AV, McCauley E. Mechanisms of Change in the Prevention of Depression: An Indicated School-Based Prevention Trial at the Transition to High School. J Am Acad Child Adolesc Psychiatry. 2020 Apr;59(4):541-551. doi: 10.1016/j.jaac.2019.05.031. Epub 2019 Jun 20.
- Makover H, Adrian M, Wilks C, Read K, Stoep AV, McCauley E. Indicated Prevention for Depression at the Transition to High School: Outcomes for Depression and Anxiety. Prev Sci. 2019 May;20(4):499-509. doi: 10.1007/s11121-019-01005-5.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 21484-EG
- R01MH061984 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
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