Smartphone-based Intervention for Young Adults With ADHD
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
2 other identifiers
interventional
70
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2026
CompletedFirst Submitted
Initial submission to the registry
June 12, 2026
CompletedFirst Posted
Study publicly available on registry
June 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2027
June 17, 2026
June 1, 2026
9 months
June 12, 2026
June 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Average Completion Rate
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
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
Secondary Outcomes (3)
Change in past-month average alcohol quantity
Enrollment to Completion of 31-Day Intervention Period,
Change in number of past-month binge-drinking episodes
Enrollment to Completion of 31-Day Intervention Period
Change in number of past-month alcohol problems reported on the Young Adult Alcohol Consequence Questionnaire
Enrollment to Completion of 31-Day Intervention Period
Other Outcomes (5)
Change in inhibitory control
Enrollment to Completion of 31-Day Intervention Period
Change in awareness
Enrollment to Completion of 31-Day Intervention Period
Change in objectively measured inhibitory control
Enrollment to Completion of 31-Day Intervention Period
- +2 more other outcomes
Study Arms (2)
Intervention Arm
EXPERIMENTALParticipants in this arm will be randomly assigned to the Experimental condition of the smartphone portion.
Control Arm
SHAM COMPARATORParticipants in this arm will be randomly assigned to the Control condition of the smartphone portion.
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Currently in high school
- Actively in treatment for Alcohol Use Disorder
- Alcohol use disorder-severe
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Related Publications (1)
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: 40880228BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Traci Kennedy, PhD.
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 12, 2026
First Posted
June 17, 2026
Study Start
June 1, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
May 1, 2027
Last Updated
June 17, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ANALYTIC CODE
- Time Frame
- Data will be uploaded to NIAAADA 6 months after data collection begins with no planned end date.
- Access Criteria
- Investigators who obtain permission to access this data in NIAAADA will have access to the 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.