Alcohol Use, Attention Deficit/Hyperactivity Disorder(ADHD)
Conditions
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.
Interventions
DEVICEEcological 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).
DEVICEEcological 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.
Sponsors
Traci Kennedy
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Completion Rate | Enrollment to Completion of 31-Day Intervention Period | 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. |
| Average mHealth App Usability Questionnaire (MAUQ) Rating | Within 1 month of intervention completion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in past-month average alcohol quantity | Enrollment to Completion of 31-Day Intervention Period, | A change in past-month average alcohol quantity from pre- to post-intervention, as measured by the 31-day timeline followback interview. |
| Change in number of past-month binge-drinking episodes | Enrollment to Completion of 31-Day Intervention Period | 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. |
| Change in number of past-month alcohol problems reported on the Young Adult Alcohol Consequence Questionnaire | Enrollment to Completion of 31-Day Intervention Period | 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. |
Countries
United States
Contacts
CONTACTTraci Kennedy, PhD
CONTACTAiden Williard, B.S.
PRINCIPAL_INVESTIGATORTraci Kennedy, PhD.
University of Pittsburgh
Outcome results
None listed