Smartphone-based Intervention for Young Adults With ADHD

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.

Conditions

• Attention Deficit/Hyperactivity Disorder(ADHD)
• Alcohol Use

Interventions

DEVICE

Ecological 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).

DEVICE

Ecological 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 & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Traci Kennedy

  lead OTHER

Principal Investigators

• Traci Kennedy, PhD. · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-15

Primary Completion

2027-03-01

Completion

2027-05-01

FDA Device

Yes

Countries

• United States

Study Locations