Attention Deficit/Hyperactivity Disorder(ADHD)NCT07654205
Smartphone-based Intervention for Young Adults With ADHD
A study testing Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group in people with Attention Deficit/Hyperactivity Disorder(ADHD) and Alcohol Use, run by Traci Kennedy at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder(ADHD), Alcohol Use
- What is being tested?
- Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2026to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Currently in high school
- Actively in treatment for Alcohol Use Disorder
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Traci Kennedy, PhD, 4122466087, kennedytm2@upmc.edu
Aiden Williard, B.S., 4127324911, williarda@upmc.edu
About this study
Official 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
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)?
Read more
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.
- Being tested
- Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group, Ecological Momentary Assessment for ADHD & Substance Use - Control Group
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological Momentary Assessment for ADHD and Substance Use - Intervention GroupDevice
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 GroupDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants in this arm will be randomly assigned to the Experimental condition of the smartphone portion. Receives: Device: Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group |
| Control Arm | Sham comparator | Participants in this arm will be randomly assigned to the Control condition of the smartphone portion. Receives: Device: Ecological Momentary Assessment for ADHD & Substance Use - Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 1 month of intervention completion
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Enrollment to Completion of 31-Day Intervention Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2026
- Study start15 Jul 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit/Hyperactivity Disorder(ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Traci Kennedy
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Traci Kennedy, University of Pittsburgh
- Investigators
- Traci Kennedy, PhD., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07654205
- Sponsor's protocol ID
- STUDY25080182
- Other IDs
- K23AA029133
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All collected IPD will be shared with the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA). Analytic code may be shared on an open science platform at the time of publication of results.
Publications
Kennedy TM, Lee CM, Molina BSG, Pedersen SL. From Assessment to Intervention: Leveraging Ecological Momentary Assessment (EMA) to Develop a Personalized mobile-health (mHealth) Ecological Momentary Intervention (EMI) for Young Adults With ADHD and High-Risk Alcohol Use. J Stud Alcohol Drugs. 2026 Jan;87(1):34-53. doi: 10.15288/jsad.24-00449. Epub 2025 Aug 29.
PubMed 40880228
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07654205
- Acronym / sponsor ID
- STUDY25080182
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Traci KennedyUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 17 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Device: Ecological Momentary Assessment for ADHD and Substance Use - Intervention GroupParticipants in this arm will be randomly assigned to the Experimental condition of the smartphone portion. |
| Control Arm | Sham comparator | Device: Ecological Momentary Assessment for ADHD & Substance Use - Control GroupParticipants in this arm will be randomly assigned to the Control condition of the smartphone portion. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Currently in high school
- Actively in treatment for Alcohol Use Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ecological Momentary Assessment for ADHD and Substance Use - Intervention GroupParticipants 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 | Intervention Arm |
| Ecological Momentary Assessment for ADHD & Substance Use - Control GroupParticipants 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. | Device | Control Arm |
Primary outcome
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.
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.
3 secondary outcomes
Change in past-month average alcohol quantity
Time frame: Enrollment to Completion of 31-Day Intervention Period,
Change in number of past-month binge-drinking episodes
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
Time frame: Enrollment to Completion of 31-Day Intervention Period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 40880228Kennedy TM, Lee CM, Molina BSG, Pedersen SL. From Assessment to Intervention: Leveraging Ecological Momentary Assessment (EMA) to Develop a Personalized mobile-health (mHealth) Ecological Momentary Intervention (EMI) for Young Adults With ADHD and High-Risk Alcohol Use. J Stud Alcohol Drugs. 2026 Jan;87(1):34-53. doi: 10.15288/jsad.24-00449. Epub 2025 Aug 29.
- Individual participant dataSharing planned: Yes. All collected IPD will be shared with the National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA). Analytic code may be shared on an open science platform at the time of publication of results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Traci Kennedy, PhD. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological Momentary Assessment for ADHD and Substance Use - Intervention Group in people with Attention Deficit/Hyperactivity Disorder(ADHD) and Alcohol Use, run by Traci Kennedy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Traci Kennedy, PhD (4122466087, kennedytm2@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Completion Rate (time frame: Enrollment to Completion of 31-Day Intervention Period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07654205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.