An interventional study of Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group and Ecological Momentary Assessment for ADHD & Substance Use - Control Group in Attention Deficit/Hyperactivity Disorder(ADHD) and Alcohol Use, sponsored by Traci Kennedy. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Traci Kennedy · Not applicable, Interventional, and Other
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's planned enrollment of 70 is close to the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →This is the only study on the registry with Traci Kennedy as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will be randomly assigned to the Experimental condition of the smartphone portion.
Device: Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group
Participants in this arm will be randomly assigned to the Control condition of the smartphone portion.
Device: Ecological Momentary Assessment for ADHD & Substance Use - Control 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).
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.
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.
Time frame: 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.
Time frame: Within 1 month of intervention completion
Change in past-month average alcohol quantity
A change in past-month average alcohol quantity from pre- to post-intervention, as measured by the 31-day timeline followback interview.
Time frame: Enrollment to Completion of 31-Day Intervention Period,
Change in number of past-month binge-drinking episodes
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.
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
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.
Time frame: Enrollment to Completion of 31-Day Intervention Period
Change in inhibitory control
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.
Time frame: Enrollment to Completion of 31-Day Intervention Period
Change in awareness
A change in awareness of inhibitory control from pre- to post-intervention, as measured by the 15 item Mindful Attention Awareness Scale (MAAS)
Time frame: Enrollment to Completion of 31-Day Intervention Period
Change in objectively measured inhibitory control
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)
Time frame: Enrollment to Completion of 31-Day Intervention Period
Change in awareness of errors on mobile CuedGoNoGo task
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.
Time frame: Enrollment to Completion of 31-Day Intervention Period
Change in ADHD symptom severity
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.
Time frame: Enrollment to Completion of 31-Day Intervention Period
Plan to share: Yes — 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.
Supporting information: 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.
Data sharing details ↗ · nda.nih.gov
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