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Идёт набор NCT07654205

Smartphone-based Intervention for Young Adults With ADHD

Без фазы С лечением Attention Deficit/Hyperactivity Disorder(ADHD) Alcohol Use

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group, Ecological Momentary Assessment for ADHD & Substance Use - Control Group.
Кому может быть актуально
Состояния в реестре: Attention Deficit/Hyperactivity Disorder(ADHD), Alcohol Use. Базовые параметры: 18 лет — 25 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство 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).
  • Устройство 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.

Первичные конечные точки

  • Average Completion Rate [Срок оценки: Enrollment to Completion of 31-Day Intervention Period]
  • Average mHealth App Usability Questionnaire (MAUQ) Rating [Срок оценки: Within 1 month of intervention completion]
Вторичные конечные точки (3)
  • Change in past-month average alcohol quantity [Срок оценки: Enrollment to Completion of 31-Day Intervention Period,]
  • Change in number of past-month binge-drinking episodes [Срок оценки: Enrollment to Completion of 31-Day Intervention Period]
  • Change in number of past-month alcohol problems reported on the Young Adult Alcohol Consequence Questionnaire [Срок оценки: Enrollment to Completion of 31-Day Intervention Period]

Критерии участия

Критерии включения

  • 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Тройное слепое
Основная цель
Другое

Центры проведения

США · 1 центр
  • University of Pittsburgh — Pittsburgh

Публикации

  • Kennedy TM, Lee CM, Molina BSG, Pedersen SL. From Assessment to Intervention: Leveraging Ecological Momentary Assessment (EMA) to Develop a Personalized mobile-health (mHealth) Ecological Momentary Intervention (EMI) for Young Adults With ADHD and High-Risk Alcohol Use. J Stud Alcohol Drugs. 2026 Jan;87(1):34-53. doi: 10.15288/jsad.24-00449. Epub 2025 Aug 29. PMID 40880228

Идентификаторы

NCT: NCT07654205 · STUDY25080182 · K23AA029133

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗