Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical Conditions
Trial of a Novel Brief Intervention on Health Behaviors for Youth With Chronic Medical
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The proposed project is a randomized control trial to assess the efficacy of an SBIRT model tailored to youth with chronic medical conditions. This trial is being built into a larger, longitudinal cohort study to assess whether a set of brief, substance specific questions can accurately predict adolescent substance use outcomes when compared to more lengthy, criterion standard assessment questions, in cross-sectional and prospective analysis. The first component of the project will consist of pre-testing an assessment battery and brief electronic intervention with a small sample of 14-17 year old youth. In the second component the investigators will randomize consented eligible participants into intervention or control arms of the study and administer the 1) Baseline Assessment Battery and the 2) Brief Intervention OR Treatment as Usual (TAU). In the third component the investigators will follow up with all participants at 6 and then 12 months after study entry to reassess rates of substance use through follow up assessment batteries.
At baseline, the investigators will also attempt to enroll parents of all participants who are present at the time of enrollment. The investigators will separately consent and administer a brief assessment battery to parents to assess their knowledge and attitudes around substance use, as well as opinions and attitudes regarding other health and risk behaviors.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Boston Children's Hospital
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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:
- 14-17 year-old youth presenting for routine medical care in the Rheumatology clinic or Endocrinology clinic at Boston Children's Hospital (BCH)
- A diagnosis of type 1 diabetes for at least a year or a diagnosis of a Rheumatologic condition for at least a year.
- Able to read and understand English at a middle school level or greater
- Consent to participation in the study and consent to the 6 month and 12 month follow up assessments.
Exclusion Criteria:
- Patients who are medically or emotionally unstable or otherwise unable to provide assent at the time of their appointment as determined by their clinician or the research team
- Unable to speak/read English at a middle school reading level
- Unable to use a computer keyboard and/or complete an interviewer-assisted questionnaire
- Do not consent to 6 month and 12 month re-assessment.
- Patients who are pregnant at baseline
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Intervention
Those in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education on substance use.
Content in the intervention will focus on health promotion and will deliver positive messages about health.
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Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.
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Sem intervenção: Control
Those in the control arm will receive treatment as usual.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Frequency and quantity of alcohol use in the past 12 months, measured using the Screen to Brief Intervention (S2BI) screening tool.
Prazo: 12 months post intervention
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We will compare changes in frequency and quantity of alcohol use over the past twelve months between the intervention and treatment as usual groups.
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12 months post intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Frequency of marijuana use in the past 12 months, measured using the S2BI Screening Tool.
Prazo: 12 months post intervention
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We will compare changes frequency of marijuana use in the past 12 months between the intervention and treatment as usual groups.
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12 months post intervention
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Perceived risk of harm of substance use
Prazo: 12 months post intervention
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We will compare self-reported perceived risk of harm of substance use between intervention and TAU groups using Monitoring the Future questions.
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12 months post intervention
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Medication Adherence measured by self-report
Prazo: 12 months post intervention
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12 months post intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sharon Levy, MD, MPH, Boston Children's Hospital
- Investigador principal: Elissa Weitzman, ScD, MSc, Boston Children's Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- P00021649
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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