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Hybrid Type 1 Trial of a Parent-Based Intervention Addressing Social Media and Adolescent Alcohol Use

18 de junio de 2026 actualizado por: Dana Litt, The University of Texas at Arlington

A Hybrid Type 1 Effectiveness Implementation Trial of a Parent-Based Intervention to Address Social Media Influences on Adolescent Alcohol Outcomes

The central goal of this application is to conduct a Hybrid Type 1 effectiveness-implementation randomized controlled trial to test the comparative effectiveness of an alcohol and social media parent-based intervention (PBI), compared to both a combined approach whereby parents receive the alcohol and social media PBI and adolescents receive an alcohol and social media personalized feedback intervention (PFI) and to an efficacious alcohol PBI handbook. Additionally, we will determine key implementation determinants that are crucial to optimizing effectiveness when delivered in community settings. The proposed study will address each of these goals in turn by enrolling parent and adolescent (age 12-17) dyads and collaborating with key community members.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

900

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Dana Litt, PhD
  • Número de teléfono: 3032044109
  • Correo electrónico: dana.litt@uta.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Parents/legal guardian inclusion criteria:

  • Have a child between the ages of 12-17 who lives with them
  • Believe that their child is active on at least one social media platform
  • Live in Texas
  • Provide a valid email and phone number
  • Own a cell phone with text messaging capabilities and be okay with receiving messages
  • Provide valid contact information for their adolescent
  • Willing to participate in respective phase.

Adolescent inclusion criteria:

  • Have an eligible parent with whom they live
  • Age 12-17
  • Live in Texas
  • Active at least weekly on at least one social media platform
  • Provide a valid phone number and email address
  • Own a cell phone with text messaging capabilities and be okay with receiving text messages,
  • Willing to participate in respective phase

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Alcohol and Social Media PBI and Adolescent Alcohol and Social Media PFI
Parents will receive the alcohol and social media PBI and adolescents will receive a brief alcohol and social media PFI based on our previous work. The PFI will use data from the adolescent baseline survey to create personalized alcohol and social media intervention feedback including normative comparisons to peers and summaries of risk behaviors. Adolescents will be encouraged to complete the PFI in one sitting but can revisit as many times as they like.
Parents will receive the alcohol and social media PBI and adolescents will receive a brief alcohol and social media PFI based on our previous work (PI: Litt, R21AA024163; Litt et al., 2023; Lewis et al., 2019; Larimer et al., 2021, 2023). The PFI will use data from the adolescent baseline survey to create personalized alcohol and social media intervention feedback including normative comparisons to peers and summaries of risk behaviors. Adolescents will be encouraged to complete the PFI in one sitting but can revisit as many times as they like.
Comparador activo: Alcohol and Social Media PBI
The alcohol and social media PBI will be based on our pilot work (R34AA026332) and updated/tailored based on Aim 1 FGs. The PBI will be delivered via a web-based format such that parents will be sent an email and a text message containing a URL to the alcohol and social media PBI website along with guidelines for working through the modules (see below for overview of modules). The website will allow parents to navigate through the modules at their own pace/sequence. Each module will have interactive elements including animations, infographics, and videos to highlight key content. Parents will be sent one text message per week encouraging them to use the website.
The alcohol and social media PBI will be based on our pilot work (R34AA026332) and updated/tailored based on Aim 1 FGs. The PBI will be delivered via a web-based format such that parents will be sent an email and a text message containing a URL to the alcohol and social media PBI website along with guidelines for working through the modules (see below for overview of modules). The website will allow parents to navigate through the modules at their own pace/sequence. Each module will have interactive elements including animations, infographics, and videos to highlight key content. Parents will be sent one text message per week encouraging them to use the website.
Comparador activo: Alcohol PBI
Parents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook (Turrisi et al., 2001, 2009, 2013) housed on the MADD website offered in English and Spanish. The alcohol PBI instructs parents to use an empathic communication style while providing information about alcohol use.
Parents will be emailed a link to the Power of Parents Handbook, which is a 52- page static PBI handbook (Turrisi et al., 2001, 2009, 2013) housed on the MADD website offered in English and Spanish. The alcohol PBI instructs parents to use an empathic communication style while providing information about alcohol use.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Drinking Refusal Self-Efficacy
Periodo de tiempo: Baseline, 1, 6, 12 month assessments
The Drinking Refusal Self-Efficacy Questionnaire will assess beliefs in one's ability to resist alcohol (Young et al., 2007; α = .96). Responses range from 1 (I am very sure I would drink) to 6 (I am sure I would not drink) with higher scores indicating greater drinking refusal self-efficacy.
Baseline, 1, 6, 12 month assessments
Alcohol-related social media communication
Periodo de tiempo: Baseline, 1, 6, 12 month assessments
Alcohol-related social media communication between parents and adolescents will be assessed using the "Alcohol-related Social Media Communication Scale, which is adapted from Turrisi et al., 2000; α = .96). Participants will indicate whether they spoke about a range of topics (yes/no) in the past month with higher scores indicating greater alcohol-related social media communication.
Baseline, 1, 6, 12 month assessments
Alcohol Willingness
Periodo de tiempo: Baseline, 1, 6, 12 month assessments
The willingness measure will assess adolescent willingness to drink in certain scenarios (α = .85; Gerrard et al., 2008) using a response rage of 0 (not at all willing) to 4 (extremely willing). Higher scores indicate greater willingness to use alcohol.
Baseline, 1, 6, 12 month assessments

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Alcohol Initiation
Periodo de tiempo: Baseline, 1, 6, 12 month assessments
Alcohol initiation for those who abstain at baseline will be calculated as time-to-event from baseline date to participants' reported date of first use using timeline follow-back methods (Sobell & Sobell, 1992) and reporting the approximate date they first used alcohol, an approach used in our current work (R01AA025611).
Baseline, 1, 6, 12 month assessments

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de julio de 2027

Finalización primaria (Estimado)

1 de agosto de 2030

Finalización del estudio (Estimado)

1 de agosto de 2030

Fechas de registro del estudio

Enviado por primera vez

15 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

18 de junio de 2026

Publicado por primera vez (Actual)

24 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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