Smartphone-based Intervention for Young Adults With ADHD
12 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Recrutamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
70
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Traci Kennedy, PhD
- Número de telefone: 4122466087
- E-mail: kennedytm2@upmc.edu
Estude backup de contato
- Nome: Aiden Williard, B.S.
- Número de telefone: 4127324911
- E-mail: williarda@upmc.edu
Locais de estudo
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Recrutamento
- University of Pittsburgh
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Contato:
- Traci Kennedy, PhD
- Número de telefone: 4122466087
- E-mail: kennedytm2@upmc.edu
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Contato:
- Aiden Williard, B.S.
- Número de telefone: 4127324911
- E-mail: williarda@upmc.edu
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Intervention Arm
Participants in this arm will be randomly assigned to the Experimental condition of the smartphone portion.
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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).
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Comparador Falso: Control Arm
Participants in this arm will be randomly assigned to the Control condition of the smartphone portion.
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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.
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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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Average Completion Rate
Prazo: Enrollment to Completion of 31-Day Intervention Period
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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.
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Enrollment to Completion of 31-Day Intervention Period
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Average mHealth App Usability Questionnaire (MAUQ) Rating
Prazo: Within 1 month of intervention completion
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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.
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Within 1 month of intervention completion
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in past-month average alcohol quantity
Prazo: Enrollment to Completion of 31-Day Intervention Period,
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A change in past-month average alcohol quantity from pre- to post-intervention, as measured by the 31-day timeline followback interview.
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Enrollment to Completion of 31-Day Intervention Period,
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Change in number of past-month binge-drinking episodes
Prazo: Enrollment to Completion of 31-Day Intervention Period
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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
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Change in number of past-month alcohol problems reported on the Young Adult Alcohol Consequence Questionnaire
Prazo: Enrollment to Completion of 31-Day Intervention Period
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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.
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Enrollment to Completion of 31-Day Intervention Period
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in inhibitory control
Prazo: 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.
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Enrollment to Completion of 31-Day Intervention Period
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Change in awareness
Prazo: Enrollment to Completion of 31-Day Intervention Period
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A change in awareness of inhibitory control from pre- to post-intervention, as measured by the 15 item Mindful Attention Awareness Scale (MAAS)
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Enrollment to Completion of 31-Day Intervention Period
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Change in objectively measured inhibitory control
Prazo: Enrollment to Completion of 31-Day Intervention Period
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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)
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Enrollment to Completion of 31-Day Intervention Period
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Change in awareness of errors on mobile CuedGoNoGo task
Prazo: Enrollment to Completion of 31-Day Intervention Period
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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.
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Enrollment to Completion of 31-Day Intervention Period
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Change in ADHD symptom severity
Prazo: Enrollment to Completion of 31-Day Intervention Period
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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.
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Enrollment to Completion of 31-Day Intervention Period
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Traci Kennedy, PhD., University of Pittsburgh
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de junho de 2026
Conclusão Primária (Estimado)
1 de março de 2027
Conclusão do estudo (Estimado)
1 de maio de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
12 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de junho de 2026
Primeira postagem (Real)
17 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
17 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STUDY25080182
- K23AA029133 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Data will be uploaded to NIAAADA 6 months after data collection begins with no planned end date.
Critérios de acesso de compartilhamento IPD
Investigators who obtain permission to access this data in NIAAADA will have access to the IPD.
Tipo de informação de suporte de compartilhamento de IPD
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Sim
produto fabricado e exportado dos EUA
Não
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 .