- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Children's Hospital Boston
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Lifetime, past 6 month and past 30 day use of substances
Prazo: 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 resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Frequency and quantity of substance use
Prazo: Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
Pre-intervention, immediate post-intervention, 6-7 months post-intervention
|
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Knowledge about effects of substance use on the brain
Prazo: 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
Prazo: 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
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 06120537
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .