Smartphone-based Intervention for Young Adults With ADHD
12. juni 2026 oppdatert 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.
Studieoversikt
Status
Rekruttering
Studietype
Intervensjonell
Registrering (Antatt)
70
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Traci Kennedy, PhD
- Telefonnummer: 4122466087
- E-post: kennedytm2@upmc.edu
Studer Kontakt Backup
- Navn: Aiden Williard, B.S.
- Telefonnummer: 4127324911
- E-post: williarda@upmc.edu
Studiesteder
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Rekruttering
- University of Pittsburgh
-
Ta kontakt med:
- Traci Kennedy, PhD
- Telefonnummer: 4122466087
- E-post: kennedytm2@upmc.edu
-
Ta kontakt med:
- Aiden Williard, B.S.
- Telefonnummer: 4127324911
- E-post: williarda@upmc.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention Arm
Participants in this arm will be randomly assigned to the Experimental condition of the smartphone portion.
|
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-komparator: Control Arm
Participants in this arm will be randomly assigned to the Control condition of the smartphone portion.
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Average Completion Rate
Tidsramme: 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
|
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Average mHealth App Usability Questionnaire (MAUQ) Rating
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in past-month average alcohol quantity
Tidsramme: 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
Tidsramme: 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
|
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Change in number of past-month alcohol problems reported on the Young Adult Alcohol Consequence Questionnaire
Tidsramme: 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
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in inhibitory control
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
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Change in ADHD symptom severity
Tidsramme: 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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Traci Kennedy, PhD., University of Pittsburgh
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. mars 2027
Studiet fullført (Antatt)
1. mai 2027
Datoer for studieregistrering
Først innsendt
12. juni 2026
Først innsendt som oppfylte QC-kriteriene
12. juni 2026
Først lagt ut (Faktiske)
17. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
17. juni 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY25080182
- K23AA029133 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
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.
IPD-delingstidsramme
Data will be uploaded to NIAAADA 6 months after data collection begins with no planned end date.
Tilgangskriterier for IPD-deling
Investigators who obtain permission to access this data in NIAAADA will have access to the IPD.
IPD-deling Støtteinformasjonstype
- ANALYTIC_CODE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Ja
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .