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| ID | Type | Description | Link |
|---|---|---|---|
| K23AA029133 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Participants in this arm will be randomly assigned to the Experimental condition of the smartphone portion. |
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| Control Arm | Sham Comparator | Participants in this arm will be randomly assigned to the Control condition of the smartphone portion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Enrollment to Completion of 31-Day Intervention Period, |
| Change in number of past-month binge-drinking episodes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Enrollment to Completion of 31-Day Intervention Period |
| Change in awareness |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Traci Kennedy, PhD | Contact | 4122466087 | kennedytm2@upmc.edu | |
| Aiden Williard, B.S. | Contact | 4127324911 | williarda@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Traci Kennedy, PhD. | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40880228 | Background | 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. |
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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.
Data will be uploaded to NIAAADA 6 months after data collection begins with no planned end date.
Investigators who obtain permission to access this data in NIAAADA will have access to the IPD.
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D004327 | Drinking Behavior |
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| Ecological Momentary Assessment for ADHD & Substance Use - Control Group | Device | 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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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 |
| 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. | Enrollment to Completion of 31-Day Intervention Period |
A change in awareness of inhibitory control from pre- to post-intervention, as measured by the 15 item Mindful Attention Awareness Scale (MAAS) |
| 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) | 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. | 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. | Enrollment to Completion of 31-Day Intervention Period |
| D001519 | Behavior |