Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Smartphone-based Intervention for Young Adults With ADHD

12 de junio de 2026 actualizado por: Traci Kennedy

Training Inhibitory Control Using Personalized Strategies (TIPS): A Randomized Controlled Feasibility Trial of a Smartphone-Based Intervention for Alcohol Use in Young Adults With ADHD

The primary goal of this clinical trial is to test if a smartphone-based intervention is feasible & acceptable among young adults with ADHD who also engage in risky drinking behaviors. A secondary aim is to test preliminary intervention efficacy. The main questions it aims to answer are:

Is the smartphone intervention feasible & acceptable for participants (e.g., are they responding regularly, is there a low level of burden reported)?

Does the smartphone intervention improve symptom awareness, inhibitory control, and problematic alcohol use?

Participants will:

Attend a virtual baseline visit to assess ADHD, alcohol use, and other life experiences.

Complete either the TIPS smartphone intervention or a control smartphone protocol over the course of 31-days, starting the first Friday after the baseline visit.

Attend a virtual follow-up visit, where many of the same questions from the baseline visit will be asked again.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

70

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: Traci Kennedy, PhD
  • Número de teléfono: 4122466087
  • Correo electrónico: kennedytm2@upmc.edu

Copia de seguridad de contactos de estudio

  • Nombre: Aiden Williard, B.S.
  • Número de teléfono: 4127324911
  • Correo electrónico: williarda@upmc.edu

Ubicaciones de estudio

  • Estados Unidos
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Reclutamiento
        • University of Pittsburgh
        • Contacto:
        • Contacto:
          • Aiden Williard, B.S.
          • Número de teléfono: 4127324911
          • Correo electrónico: williarda@upmc.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

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age 18-25
  • Current diagnosis of Attention Deficit/Hyperactivity Disorder-Combined Type according to the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM 5)
  • Drinks at least 4 (for females) / 5 (for males) alcoholic drinks in a single drinking session at least once per week
  • Owns a smartphone
  • Reads and understands English

Exclusion Criteria:

  • Currently in high school
  • Actively in treatment for Alcohol Use Disorder
  • Alcohol use disorder-severe

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: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Triple

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention Arm
Participants in this arm will be randomly assigned to the Experimental condition of the smartphone portion.
Dispositivo: Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group
Participants will rate their ADHD symptoms and impairment 4 times daily. Feedback on changes in ADHD symptoms will be provided visually via a graph at each prompt. They will also be texted suggestions following each survey to try behavioral strategies intended to help with their inhibitory control ADHD symptoms and related problems, with a particular focus on alcohol use and problems).
Comparador falso: Control Arm
Participants in this arm will be randomly assigned to the Control condition of the smartphone portion.
Dispositivo: Ecological Momentary Assessment for ADHD & Substance Use - Control Group
Participants will receive 4 prompts per day in the same time windows as participants in the intervention group. However, participants in the control conditions will not be given the 3 TIPS intervention components (symptom monitoring, symptom feedback, and tailored strategy suggestions) and instead will report about their drinking behaviors. They will also answer several "neutral" questionnaires that have been designed by the study team to keep intervention prompt length similar between groups.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Average Completion Rate
Periodo de tiempo: Enrollment to Completion of 31-Day Intervention Period
Completion rate will be defined as number of surveys completed out of the 124 that will be sent during the 31-day smartphone intervention period. 4 surveys will be sent every day. An average completion rate of 80% in the intervention group would indicate good feasibility.
Enrollment to Completion of 31-Day Intervention Period
Average mHealth App Usability Questionnaire (MAUQ) Rating
Periodo de tiempo: Within 1 month of intervention completion
The usability of the smartphone intervention will be assessed using the 18-item mHealth App Usability Questionnaire (MAUQ), rated from 1-disagree to 7-agree, with an average of at least 5 indicating good usability.
Within 1 month of intervention completion

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in past-month average alcohol quantity
Periodo de tiempo: Enrollment to Completion of 31-Day Intervention Period,
A change in past-month average alcohol quantity from pre- to post-intervention, as measured by the 31-day timeline followback interview.
Enrollment to Completion of 31-Day Intervention Period,
Change in number of past-month binge-drinking episodes
Periodo de tiempo: Enrollment to Completion of 31-Day Intervention Period

A change in number of past-month binge-drinking episodes from pre- to post- intervention, as measured by the timeline followback interview.

Binge-drinking is defined as drinking 4 or more drinks in assigned female at birth participants, or 5 or more drinks in assigned male at birth participants within a 2-hour period.
Enrollment to Completion of 31-Day Intervention Period
Change in number of past-month alcohol problems reported on the Young Adult Alcohol Consequence Questionnaire
Periodo de tiempo: Enrollment to Completion of 31-Day Intervention Period
Participants will complete the 23-item Young Adult Alcohol Consequence Questionnaire at baseline (pre-intervention) and follow-up (post-intervention). For each item, participants will indicate whether the item is something they have experienced in the past month.
Enrollment to Completion of 31-Day Intervention Period

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in inhibitory control
Periodo de tiempo: Enrollment to Completion of 31-Day Intervention Period
Participants and collateral reported will complete the 8-item Inhibit subscale of the Behavior Rating Inventory of Executive Function Adult Version (BRIEF-A) at baseline (pre-intervention) and post-intervention follow-up.
Enrollment to Completion of 31-Day Intervention Period
Change in awareness
Periodo de tiempo: Enrollment to Completion of 31-Day Intervention Period
A change in awareness of inhibitory control from pre- to post-intervention, as measured by the 15 item Mindful Attention Awareness Scale (MAAS)
Enrollment to Completion of 31-Day Intervention Period
Change in objectively measured inhibitory control
Periodo de tiempo: Enrollment to Completion of 31-Day Intervention Period
A change in objectively measured inhibitory control based on mobile CuedGoNoGo responses (rate of commission errors, i.e., when the participant tapped their screen when they weren't supposed to)
Enrollment to Completion of 31-Day Intervention Period
Change in awareness of errors on mobile CuedGoNoGo task
Periodo de tiempo: Enrollment to Completion of 31-Day Intervention Period
A change in awareness of errors made on the mobile CuedGoNoGo task (i.e., accuracy of participant's guess of how many commission errors they made), assessed immediately after completion of the task.
Enrollment to Completion of 31-Day Intervention Period
Change in ADHD symptom severity
Periodo de tiempo: Enrollment to Completion of 31-Day Intervention Period
A change from baseline to post-intervention follow-up in ADHD symptom severity, as measured by clinician-administered and collateral informant-reported ADHD Rating Scale scores.
Enrollment to Completion of 31-Day Intervention Period

Colaboradores e Investigadores

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

Patrocinador

Traci Kennedy

Colaboradores

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigadores

  • Investigador principal: Traci Kennedy, PhD., University of Pittsburgh

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

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 junio de 2026

Finalización primaria (Estimado)

1 de marzo de 2027

Finalización del estudio (Estimado)

1 de mayo de 2027

Fechas de registro del estudio

Enviado por primera vez

12 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

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

12 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY25080182
  • K23AA029133 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

All collected IPD will be shared with the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA).

Analytic code may be shared on an open science platform at the time of publication of results.

Marco de tiempo para compartir IPD

Data will be uploaded to NIAAADA 6 months after data collection begins with no planned end date.

Criterios de acceso compartido de IPD

Investigators who obtain permission to access this data in NIAAADA will have access to the IPD.

Tipo de información de apoyo para compartir IPD

  • CÓDIGO_ANALÍTICO

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.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Consumo de alcohol

Buscar ensayos similares

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

CROs by country

CROs in Slovakia

Condiciones

Enfermedades Raras

Intervenciones de drogas

Suplementos dietéticos

Patrocinador / Colaboradores

Localizaciones

Suscribir