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NCT Number: NCT07654205

Smartphone-based Intervention for Young Adults With ADHD

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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Key information

Conditions

Attention Deficit/Hyperactivity Disorder(ADHD) Alcohol Drinking Alcohol Use Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Behavior Drinking Behavior Mental Disorders Neurodevelopmental Disorders

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Alcohol use disorder-severe

Treatment and study plan

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.

Primary outcomes

  1. Average Completion Rate

    Time frame: 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.

  2. Average mHealth App Usability Questionnaire (MAUQ) Rating

    Time frame: 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 outcomes

  1. Change in past-month average alcohol quantity

    Time frame: 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.

  2. Change in number of past-month binge-drinking episodes

    Time frame: 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.

  3. Change in number of past-month alcohol problems reported on the Young Adult Alcohol Consequence Questionnaire

    Time frame: 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.

Other outcomes

  1. Change in inhibitory control

    Time frame: Enrollment to Completion of 31-Day Intervention Period

    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.

  2. Change in awareness

    Time frame: 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)

  3. Change in objectively measured inhibitory control

    Time frame: Enrollment to Completion of 31-Day Intervention Period

    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)

  4. Change in awareness of errors on mobile CuedGoNoGo task

    Time frame: Enrollment to Completion of 31-Day Intervention Period

    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.

  5. Change in ADHD symptom severity

    Time frame: Enrollment to Completion of 31-Day Intervention Period

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aiden Williard, B.S.

CONTACT

[email protected]

4127324911

Traci Kennedy, PhD

CONTACT

[email protected]

4122466087

Sponsors and collaborators

Lead sponsor

Traci Kennedy

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Training Inhibitory Control Using Personalized Strategies (TIPS): A Randomized Controlled Feasibility Trial of a Smartphone-Based Intervention for Alcohol Use in Young Adults With ADHD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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