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Recruiting NCT07654205

Smartphone-based Intervention for Young Adults With ADHD

No phase Interventional Attention Deficit/Hyperactivity Disorder(ADHD) Alcohol Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group, Ecological Momentary Assessment for ADHD & Substance Use - Control Group.
Who it may be relevant to
Registry conditions: Attention Deficit/Hyperactivity Disorder(ADHD), Alcohol Use. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Device 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).
  • Device 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.

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

United States · 1 center
  • University of Pittsburgh — Pittsburgh

Publications

  • 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

Identifiers

NCT: NCT07654205 · STUDY25080182 · K23AA029133

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗