- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00612482
Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education
Youth Substance Use Prevention/Reduction Through Science-based Drug Abuse Education: A High School Pilot Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
NIDA, in recent years, has put resources into summarizing and synthesizing cutting-edge medical and basic science research discoveries about the short-term and long-term effects of drug use on the developing brain. One outcome of this results was the production of a science-based drug education program entitled "The Brain: Understanding Neurobiology Through the Study of Addiction." This is a 5-lesson module for high school science classes that teaches about brain structure and function, how drugs affect and change the biology and chemistry of the brain, how addiction occurs in the brain, and that addiction is a chronic, recurring disease. However, the effect of receipt of this program on students' substance use knowledge, attitudes, perceived risk of harm, and behavior has not been systematically evaluated to date.
The specific aims of this project are:
- To evaluate the effects of receipt of the curriculum on specific cognitive contributors to substance use including a)students' knowledge about the short- and long-term effects of substance use on the brain; b)perceived risk of harm from substance use; and c)intention to use substances in the next 3 months.
- To evaluate the effects of the intervention on actual substance use behavior. We hypothesize that the effectiveness of this approach may be modified by the students' level of prior and current substance use, with the effect being stronger among those who have not already initiated use, or among those who have very low use. Therefore, we will specifically examine whether the intervention a)prevents substance use initiation among students who had no previous use, b)stops use among students with low lifetime use, and c) reduces use among those with higher levels of use.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital Boston
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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:
- Student in 9th/10th/11th grade science classes at Fenway High School at start of study or student in 11th grade science classes at Boston Arts Academy at start of study
- Parental permission to participate
Exclusion Criteria:
- No parental permission to participate
- Unable to read English
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 1
Participants in the "no intervention" condition will receive the usual high school science curriculum.
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Experimental: 2
Participants in the "experimental" arm will receive the 5-lesson, science-based substance abuse prevention curriculum in their science classes.
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Participants in the "experimental" arm of the study will receive the 5-lesson, science-based drug prevention curriculum in their science classes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Lifetime, past 6 month and past 30 day use of substances
Periodo de tiempo: Pre-intervention, immediate post-intervention, 6-7 month post-intervention
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Pre-intervention, immediate post-intervention, 6-7 month post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Frequency and quantity of substance use
Periodo de tiempo: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
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Pre-intervention, immediate post-intervention, 6-7 months post-intervention
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Knowledge about effects of substance use on the brain
Periodo de tiempo: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
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Pre-intervention, immediate post-intervention, 6-7 months post-intervention
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Perceived risk of harm of substance use
Periodo de tiempo: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
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Pre-intervention, immediate post-intervention, 6-7 months post-intervention
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Intention to use substances in the next 3 months
Periodo de tiempo: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
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Pre-intervention, immediate post-intervention, 6-7 months post-intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sion Kim Harris, PhD, Boston Children's Hospital
Publicaciones y 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
- 06120537
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .