Pilot of a Drug Education Curriculum for Middle and High School Students (iDECIDE)
Development of a Drug Education Curriculum for Middle and High School Students
The goal of this pilot study is to measure the feasibility, sustainability, and acceptability of a drug education curriculum (IDECIDE) in middle and high students who have endorsed past-month substance use.The main question it aims to answer is:
1) What is the impact of iDECIDE on the the knowledge of drug effects and teen brain development, attitudes and perceptions of drug-related harms, and willingness to quit or reduce substance use?
Participants will be asked to participate in 4 sessions of the iDECIDE curriculum and complete surveys and interview questionnaires over the course of approximately 3 months.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This study will be a one-arm pilot study enrolling approximately 100 middle and high school students who have endorsed substance use in the past month. Participants will be followed over 3 months. All participants will receive iDECIDE developed to provide behavioral support and psychoeducation via videoconference or in-person visits. The purpose of iDECIDE is to provide students with the knowledge and skills they need to make healthy decisions regarding substance use. Data collection will occur during seven visits over the span of approximately three months, including one baseline visit, four weekly visits during the intervention phase of the study, and then two follow-up visits. The follow-up visits will occur at approximately one week and one month following the end-of-intervention. Participants will complete questionnaires and assessments throughout the study. Primary outcomes (Knowledge of Drug Effects and Brain Development readiness to quit, readiness to reduce, perceptions of harm) will be assessed at visit 1 (baseline), visit 6 (one week follow-up), and visit 7 (one month follow-up). Participants will be compensated for session attendance.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Children and adolescents who are currently enrolled in middle or high school;
- Have currently used (i.e., at least once in the past 30 days) any substance without a prescription;
- Have a parent or legal guardian who is able and willing to provide written informed consent for the active study phase (if under the age of 18);
- Competent and willing to provide written informed assent for the active study phase (if under the age of 18);
- Competent and able to provide written informed consent (if age 18 or older);
- Able to communicate in English language;
- Able to commit to 7 study visits in approximately 2 months;
- Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator;
- Has access to a reliable internet connection and a device that can run Zoom.
Exclusion Criteria:
- Ever been in substance use treatment;
- Ever engaged in IV drug use;
- Current daily alcohol, or daily non-medical benzodiazepine and/or opioid use.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: iDECIDE
Participants will…
|
iDECIDE is a 4-session drug education and diversion program that addresses topics such as the neurobiology and addiction, adolescent brain development, industry tactics, motives for using substances, risk and protective factors, identifying triggers, healthy alternatives, core values, and long-term goal setting. These topics are taught via facilitated discussions, videos, worksheets, and handouts. The iDECIDE drug curriculum will be delivered weekly for 4 weeks via videoconference or in-person visits. Each session typically takes 60-75 minutes. For this study, facilitators are members of study staff. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Knowledge of Drug Effects & Brain Development
Prazo: Baseline, one-week follow-up, one-month follow-up
|
Knowledge of Drug Effects and Brain Development will be measured by number of items correct on a 25-item multiple-choice questionnaire that assesses knowledge taught in the iDECIDE curriculum, including neurobiology of addiction, side effects of substance, and industry tactics to market substances to young audiences. |
Baseline, one-week follow-up, one-month follow-up
|
|
Readiness to Quit or Reduce Substance Use
Prazo: Baseline, one-week follow-up, one-month follow-up
|
Participants will complete a Readiness Ruler to determine how ready they are to quit and reduce their primary substance on a scale from 1 (not at all ready) to 10 (very ready). |
Baseline, one-week follow-up, one-month follow-up
|
|
Perceived Harm of Substance Use
Prazo: Baseline, one-week follow-up, one-month follow-up
|
The Perceived Harm of Substance Use measure was modified from the 2010 National Survey on Drug Use and Health. Participants will assess their perceived harm of various forms of substance use using four response categories that range from no risk to great risk. |
Baseline, one-week follow-up, one-month follow-up
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Frequency of Substance Use
Prazo: Baseline, one-week follow-up, one-month follow-up
|
The Timeline Follow-Back (TLFB) will be used to measure number of days the participant used a substance, which substances were used, and the frequency of which substances were used. The initial TLFB at the baseline visit will measure substances used in the past 90 days. Participants will be prompted to share their substance use since their baseline and follow-up visits during the one-week and one-month follow-up visits, respectively. |
Baseline, one-week follow-up, one-month follow-up
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Anxiety symptoms
Prazo: Baseline, one-week follow-up, one-month follow-up
|
The Screen for Child Anxiety Related Emotional Disorders Revised (SCARED-R) questionnaire is a 66-item self-report questionnaire to measure DSM child anxiety symptoms. Participants are asked to endorse how frequently they have experienced each symptom on a 3-point scale: 0 ("almost never"), 1 ("sometimes"), and 2 ("often"). A total score (0-132) and anxiety sub-scores are calculated by adding item scores. |
Baseline, one-week follow-up, one-month follow-up
|
|
Depressive symptoms
Prazo: Baseline, one-week follow-up, one-month follow-up
|
The Center for Epidemiological Studies Depression Scale for Children (CES-DC) is a 20-item questionnaire for assessing past-week depressive symptoms in children and adolescents. Responses range from 0 ("not at all") to 3 ("a lot"). Total scores can range from 0-60. |
Baseline, one-week follow-up, one-month follow-up
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Links úteis
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 (Real)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2020P000727
- INTF2300H78500224179 (Número de outro subsídio/financiamento: Massachusetts Department of Public Health)
- INTF2400H78500224455 (Número de outro subsídio/financiamento: Massachusetts Department of Public Health)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Individual participant data that underlie reported results (after de-identification [text, tables, figures, and appendices]), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@harvard.mgh.edu. To gain access, data requestors will need to sign a data access agreement.
Prazo de Compartilhamento de IPD
Beginning 3 months and ending 5 years following article publication
Critérios de acesso de compartilhamento IPD
Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data access agreement required.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .