Smartphone-based Intervention for Young Adults With ADHD

ConditionsAttention Deficit/Hyperactivity Disorder(ADHD)Alcohol Use

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-25

SponsorTraci Kennedy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Currently in high school

Actively in treatment for Alcohol Use Disorder

Trial design

Design model

Parallel

Treatments tested in this trial

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).
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.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Intervention ArmExperimental treatment 1 intervention

Group B: Control ArmSham comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Traci Kennedy

Lead sponsor

University of Pittsburgh

Sponsor institution

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov

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