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Smartphone-based Intervention for Young Adults With ADHD

14 augusti 2026 uppdaterad av: Traci Kennedy

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)?

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

70

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Förenta staterna, 15213
        • Rekrytering
        • University of Pittsburgh
        • Kontakt:
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Trippel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Intervention Arm
Participants in this arm will be randomly assigned to the Experimental condition of the smartphone portion.
Enhet: 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).
Sham Comparator: Control Arm
Participants in this arm will be randomly assigned to the Control condition of the smartphone portion.
Enhet: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Average Completion Rate
Tidsram: 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.
Enrollment to Completion of 31-Day Intervention Period
Average mHealth App Usability Questionnaire (MAUQ) Rating
Tidsram: 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.
Within 1 month of intervention completion

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in past-month average alcohol quantity
Tidsram: 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.
Enrollment to Completion of 31-Day Intervention Period,
Change in number of past-month binge-drinking episodes
Tidsram: 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.
Enrollment to Completion of 31-Day Intervention Period
Change in number of past-month alcohol problems reported on the Young Adult Alcohol Consequence Questionnaire
Tidsram: 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.
Enrollment to Completion of 31-Day Intervention Period

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in inhibitory control
Tidsram: 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.
Enrollment to Completion of 31-Day Intervention Period
Change in awareness
Tidsram: 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)
Enrollment to Completion of 31-Day Intervention Period
Change in objectively measured inhibitory control
Tidsram: 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)
Enrollment to Completion of 31-Day Intervention Period
Change in awareness of errors on mobile CuedGoNoGo task
Tidsram: 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.
Enrollment to Completion of 31-Day Intervention Period
Change in ADHD symptom severity
Tidsram: 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.
Enrollment to Completion of 31-Day Intervention Period

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Traci Kennedy

Samarbetspartners

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Utredare

  • Huvudutredare: Traci Kennedy, PhD., University of Pittsburgh

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 juli 2026

Primärt slutförande (Beräknad)

1 mars 2027

Avslutad studie (Beräknad)

1 maj 2027

Studieregistreringsdatum

Först inskickad

12 juni 2026

Först inskickad som uppfyllde QC-kriterierna

12 juni 2026

Första postat (Faktisk)

17 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 augusti 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY25080182
  • K23AA029133 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

Data will be uploaded to NIAAADA 6 months after data collection begins with no planned end date.

Kriterier för IPD Sharing Access

Investigators who obtain permission to access this data in NIAAADA will have access to the IPD.

IPD-delning som stöder informationstyp

  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Nej

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