Recruiting

TIPS

Sponsor:

Traci Kennedy

Code:

NCT07654205

Conditions

Attention Deficit/Hyperactivity Disorder(ADHD)

Alcohol Use

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

Interventions

Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group

Ecological Momentary Assessment for ADHD & Substance Use - Control Group

Study Details

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.

Conditions

Attention Deficit/Hyperactivity Disorder(ADHD)

Alcohol Use

Study ID

NCT07654205

Start date

Jul 15, 2026

Status verified date

Jul, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Participants in this arm will be randomly assigned to the Experimental condition of the smartphone portion.

sham comparator: Control Arm

Participants in this arm will be randomly assigned to the Control condition of the smartphone portion.

Interventions

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).

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.

Primary outcome measure

  • Average Completion Rate [ Time Frame: Enrollment to Completion of 31-Day Intervention Period ]
  • Average mHealth App Usability Questionnaire (MAUQ) Rating [ Time Frame: Within 1 month of intervention completion ]

Central Contacts and Locations

Central contacts

Traci Kennedy, PhD

4122466087kennedytm2@upmc.edu

Aiden Williard, B.S.

4127324911williarda@upmc.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Traci Kennedy, PhD

4122466087kennedytm2@upmc.edu

Aiden Williard, B.S.

4127324911williarda@upmc.edu

More Information

Sponsor

Traci Kennedy

Last update posted

Aug 18, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Traci Kennedy on 2026-08-18.