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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06593652
Evaluación de la participación del cuidador en intervenciones breves basadas en atención primaria para problemas de consumo de alcohol en adolescentes
Intervention for mild severity alcohol use among U.S. teens is crucial, as alcohol is the most commonly used substance in this age group, yet few receive the necessary interventions. Primary care, where over 90% of youth regularly visit, is an ideal setting for identifying and addressing mild alcohol use disorder (AUD) through brief interventions like motivational interviewing (MI) and cognitive-behavioral therapy (CBT). However, for teens with mild AUD, a single brief session may not be sufficient, raising questions about the role of caregiver involvement. This study seeks to determine the most effective level of caregiver involvement-no involvement, a single live session, or an online self-paced program-in reducing alcohol use or other substance use among adolescents with mild AUD/SUD in primary care/adolescent clinic settings. The study also explores the impact of these interventions on other outcomes such as substance use, psychosocial functioning, behavioral health services engagement, as well as the factors influencing treatment response. The results will guide the selection and implementation of effective, scalable interventions in primary care to address youth alcohol use and other substance use disorders.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Detailed Description
Intervention for mild severity alcohol use is needed in primary care. Alcohol is the most commonly used substance among U.S. teens (lifetime use: 62% of 12th graders) and contributes to myriad harms, yet few youth who may benefit from intervention ever receive it. Primary care is an ideal setting for identifying and delivering brief interventions to youth with mild severity alcohol problems since over 90% of youth attend primary care visits routinely and substance use screening is standard practice. For youth with infrequent, low-risk use, brief (15-30 minute) motivational conversations may be sufficient to reduce risk. In contrast, youth with moderate to severe alcohol problems typically require more intensive interventions delivered by behavioral health specialists (e.g., intensive outpatient, residential treatment). A critical decision faced in primary care settings is what to do for youth who fall between these ends of the spectrum-namely, youth who show early signs of problematic use, meeting criteria for mild severity alcohol use disorder (AUD) (i.e., 2-3 symptoms; estimated to be approximately 3% of youth aged 12-17). Strong evidence supports individual-level brief interventions that incorporate motivational interviewing (MI) and basic cognitive-behavioral therapy (CBT) skills to help youth reduce substance use frequency, volume, and related impairment among youth with mild AUD.
Caregiver involvement in brief interventions for mild severity AUD may improve outcomes. Systematic reviews support interventions that address family-level factors (e.g., parents' attitudes, parenting behavior). When and how to involve parents or other primary caregivers in interventions for youth with mild severity AUD remains unclear. For instance, in a large school-based trial, brief MI+CBT without a caregiver session was equivalent to brief MI+CBT with a caregiver session on alcohol outcomes and drug consequences, whereas the MI+CBT with a caregiver session modestly outperformed the adolescent-only condition on cannabis-related outcomes.
Directly intervening with caregivers can be difficult and impractical. Despite the potential benefits of caregiver involvement, many caregivers see their child's behavior and choices as the main concern and therefore may be less inclined to participate in services focused exclusively on parenting practices. Caregivers may also have to miss work for parenting-dedicated sessions, which can disproportionately impact economically disadvantaged families. Asynchronous online programming may address some of these barriers-and preliminary findings support acceptability and efficacy of this approach-but such programs remain understudied relative to more traditional program structures. Identifying the relative effectiveness of online versus in-person caregiver components compared to youth-only interventions is critical to support decisions and eventual cost-benefit analyses about which programs to offer to different patients.
The primary research question this study aims to address is, "What type and level of caregiver involvement in a brief youth-focused intervention (i.e., Teen Intervene) results in the greatest reductions in alcohol and other substance use among adolescents with mild alcohol use disorder/ substance use disorder when delivered in a primary care/other adolescent clinic context: no caregiver involvement, a single dedicated parent session, or a self-paced online parenting program?" Secondary research questions are "What is the relative impact of the three intervention models on other substance, academic, and behavioral health outcomes?" and "Do youth (i.e., personality, alcohol/substance risk perceptions, etc.) and family factors (i.e., parental monitoring) moderate treatment response?" Understanding implementation factors associated with each intervention is also of interest, as engaging caregivers in youth SUD services can be challenging. Thus, the outcomes of the current project will help inform the selection and delivery of interventions that are both effective and reasonable to implement in primary care contexts, where most youth receive healthcare services. When delivered at scale, such interventions could help address the alcohol and other substance use disorders affecting the U.S. today.
Specific Aims
A Type 1 hybrid effectiveness-implementation trial is proposed to compare the effectiveness of an individual skill-building MI+CBT brief intervention (Teen Intervene, TI) with varying caregiver involvement: a) no caregiver involvement, b) a single live caregiver session, and c) an online, self-paced parenting program (Family Check-Up Online, FCU). These brief intervention programs will be tested as a first-level intervention to address mild SUD and prevent progression to more severe AUD/SUD symptoms or patterns of use. The aims are two-fold:
Aim 1: Compare the effectiveness of a youth-focused brief intervention (TI) when delivered without caregiver involvement (TI-A) versus with an added caregiver session (TI-A+P) versus with an online caregiver component (TI-A+FCU) in reducing substance use in adolescents with mild AUD/SUD in primary care. The overall magnitude of response and percentage of youth in each condition with clinically meaningful changes (i.e., % responders) will be measured. It is predicted that TI-A+P > TI-A+FCU > TI-A. Secondary outcomes will include AUD/SUD symptoms, general psychosocial functioning, engagement in youth behavioral health services.
Aim 2: Identify youth and family factors associated with intervention response versus non-response in each treatment condition, such as baseline substance use intensity (frequency, volume, duration, type), youth and caregiver perception of substance use risk, youth personality factors (impulsivity, emotion dysregulation), and baseline parenting practices. Intervention implementation factors will also be examined. This aim will be accomplished through both quantitative and qualitative measures.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: SPARC Research Team
- Número de teléfono: (317) 274-7715
- Correo electrónico: sparc@iu.edu
Copia de seguridad de contactos de estudio
- Nombre: Zachary Adams, PhD, HSPP
- Número de teléfono: 317-278-0591
- Correo electrónico: zwadams@iu.edu
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46112
- Reclutamiento
- IU Health/Indiana University School of Medicine
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Investigador principal:
- Zack Adams, PhD, HSPP
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Investigador principal:
- Tamika Zapolski, PhD, HSPP
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Contacto:
- SPARC Research Team
- Número de teléfono: (317) 274-7715
- Correo electrónico: sparc@iu.edu
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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:
- 12-18 years old;
- Mild to moderate severity for substance use (based on screeners such as AUDIT, CUDIT, BSTAD, KCAT SUD, S2BI, CRAFFT, etc.)
- English language fluency
Exclusion Criteria:
- N/A
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Teen Intervene - Adolescent Only
Only the youth will participate in brief intervention, Teen Intervene (3 sessions). The youth will participate in manual-standardized Teen Intervene sessions. |
Teen Intervene (TI) is delivered over two or three, 45- to 60-minute sessions (2 teen sessions +/- 1 caregiver session) to reduce youth substance use, increase motivation for abstinence, and promote use of existing coping strategies. TI is an adolescent-appropriate adaptation of motivational enhancement therapy (MET), and includes a discussion of readiness to change, goal setting, personal feedback, a functional analysis of substance use, and a review of coping skills. |
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Experimental: Teen Intervene - Caregiver Involvement
The youth will participate in three Teen Intervene sessions. Additionally, the caregiver(s) will participate in a single, caregiver-only Teen Intervene session. |
Teen Intervene (TI) is delivered over two or three, 45- to 60-minute sessions (2 teen sessions +/- 1 caregiver session) to reduce youth substance use, increase motivation for abstinence, and promote use of existing coping strategies. TI is an adolescent-appropriate adaptation of motivational enhancement therapy (MET), and includes a discussion of readiness to change, goal setting, personal feedback, a functional analysis of substance use, and a review of coping skills. In this condition, the caregiver session will address caregiver expectations around youth substance use and strategies for promoting positive youth behavior change including reduced substance use. |
|
Experimental: Teen Intervene - Online Caregiver Support Tool
Only the youth will participate in the brief intervention, Teen Intervene. The youth will participate in three Teen Intervene sessions. Caregiver(s) will be provided with an online tool (Family Checkup Online) that addresses parenting strategies to support their youth. |
Family Check-Up Online (FCU-O) is a self-paced, parent-driven, fully HIPAA compliant online version of the Family Check-Up (FCU), a brief intervention that integrates assessment, motivation-enhancement, and skill building to help parents effectively manage behavior and build positive relationships with their children aged 2-17 in order to reduce emotional and behavioral problems among youth. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Timeline Follow-Back
Periodo de tiempo: *0-at time of baseline, post intervention, *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
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Primary outcome: 30 items that assess daily alcohol usage over the past month will be administered to all participants. Participants will be queried about # of use days, # drinks/times, # binge episodes for 30 days. |
*0-at time of baseline, post intervention, *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
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Timeline Follow-Back
Periodo de tiempo: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
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Co-primary outcome: 30 items that assess daily substance (cannabis, nicotine, and other illicit substances) usage over the past month will be administered to all participants. Participants will be queried about #of use days, #times, #binge episodes for 30 days. |
*0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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DAST
Periodo de tiempo: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
28 items that review drug use symptoms will be administered to all participants. |
*0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
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Youth Services Engagement
Periodo de tiempo: *0-at time of baseline, *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
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2 items that review youth services received by the participant (e.g., mental health treatment, substance use treatment, hospitalization) over the past 3 months per caregiver report. This will be asked to all participant caregivers. |
*0-at time of baseline, *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
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PROMIS Surveys
Periodo de tiempo: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
37 items that review Psychosocial Functioning (Peer Relationships, Life Satisfaction, Depression, Anxiety, Anger/Irritability, and Psychological Stress Experiences). These items will be administered to all participants. |
*0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
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AUDIT for Teen
Periodo de tiempo: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
12 item measure used to assess alcohol consumption levels among adolescents. |
*0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
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DUDIT for Teen
Periodo de tiempo: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
11 item measure used to assess level of drug use among adolescents |
*0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
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CUDIT for Teen
Periodo de tiempo: *0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
8 item measure used to assess cannabis misuse among adolescents |
*0-at time of baseline, post-intervention; *3 months after baseline; *6 months after baseline; *9 months after baseline; *12 months after baseline
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Zachary Adams, PhD, HSPP, Indiana University
- Investigador principal: Tamika Zapolski, PhD, HSPP, Indiana University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
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
- 23394
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Though the researchers are not required to provide information about plans to share individual participant data (IPD), we plan to withhold individual participant data from sharing. This decision aligns with university policy and the terms outlined in our participants' consent forms, which stipulate that patient information will not be shared publicly.
Información sobre medicamentos y dispositivos, documentos del estudio
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