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Supporting Adolescent Alcohol Treatment With Computer-Based ('Path180') Skills Training

14. juli 2026 opdateret af: Brown University
This 8-week clinical trial will test a computer-based skills training program called Path180 with 112 adolescents aged 13 to 19 who are receiving mental health counseling or outpatient substance use treatment. Participants will be randomly assigned to either standard treatment (treatment as usual) or standard treatment plus Path180. The study will use ecological momentary assessment (EMA) to closely track how Path180 may influence the use of CBT skills and clinical outcomes in daily life. The goal is to help make evidence-based treatment more accessible for underserved youth in the early stages of alcohol use disorder.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Adolescent alcohol use remains a major public health issue worldwide. Clinical trials of psychosocial interventions for young people have shown only modest short-term results. New digital tools, such as computer-based programs, may improve treatment. Path180 is a computer-based program designed to help reduce alcohol use among teenagers by offering engaging, evidence-based content. However, few studies have examined the effectiveness of digital interventions such as Path180 for young people. This gap raises important questions about whether computer-based programs can help adolescents. The goal of this study is to assess how well teenagers accept Path180 as a way to reduce alcohol use. The study will also examine whether using Path180 leads to lower alcohol use among teenagers already getting professional help for mental health or alcohol-related issues.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

112

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02912

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Ages 13 to 19 years, inclusive; we will exclude children < 13 due to diversity across adolescence and youths > 19 because our focus is teenagers
  • Seeking/receiving mental health counseling and/or outpatient substance use disorder treatment at Bradley Hospital or another national clinic/treatment service
  • Self-reported alcohol use in the past year
  • Meets criteria for a current DSM-5 alcohol use disorder assessed using the Schedule for Affective Disorders and Schizophrenia for School-Age Children: Present and Lifetime Version (K-SADS)
  • Able to understand written and oral instructions in English, communicate understanding of the consent/assent form, and provide written informed consent/assent
  • Complete all assessments required at screening.
  • Provide contact information of someone, such as a parent or other family member, who may be able to contact the participant in case of a missed study appointment or follow-up assessment.
  • Agree to the schedule of visits, verbally acknowledge that he/she/they will be able to attend each scheduled visit, participate in phone visits and that he/she/they does not have any already scheduled events or a job that may substantially interfere with study participation.
  • If younger than 18 years, permission from the minor's legal authorized representative (e.g., caregiver, parent) is required, herein referred to as parent permission.

Exclusion Criteria:

  • Current significant alcohol withdrawal symptoms (score > 10) on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-AR); those with current significant alcohol withdrawal may be re-screened after stabilization
  • DSM-5 criteria for a severe SUD besides alcohol, cannabis and tobacco
  • Psychosis NOTE: Prospective participants diagnosed with psychiatric disorders not specifically excluded above may be included at the discretion of the principal investigator as long as the concurrent treatment for the comorbid psychiatric condition does not compromise the study integrity by virtue of its type, duration, or intensity.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Standard Treatment
Participants randomized to Standard Treatment will receive treatment as usual at a behavioral healthcare facility.
Eksperimentel: Path180
Youth randomized to this condition will have unlimited access to the Path180 platform throughout the 8-week skills training period.
Adfærdsmæssigt: Path180
Path180 is a 7-module computer-based skills training program designed specifically for teenagers. Whenever possible, participants assigned to this group will complete one module of Path180 at each of the first 7 weekly Check-in Visits. By educating teenagers about alcohol, boosting their motivation to change, and teaching a series of coping skills, Path180 was created to help youth cut back or stop drinking alcohol. Each module is brief (~20 minutes) and uses a variety of strategies and interactive exercises to help teenagers learn new skills and apply them in their daily lives. Youth randomized to this condition will have unlimited access to the Path180 platform throughout the 8-week skills training period.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of participants who complete the active treatment phase
Tidsramme: 8-week active treatment phase
The number of participants who complete the active treatment phase will determine feasibility.
8-week active treatment phase
Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8
Tidsramme: 8-week active treatment phase
The Client Satisfaction Questionnaire (CSQ-8), which ranges in scores from 8 to 32 (higher scores indicate higher satisfaction), will determine acceptability. Treatment satisfaction will be considered acceptable if the number and percentage of subjects who rate their treatment experience in the "satisfactory" or "highly satisfactory" range on the CSQ-8 is ≥ 80%.
8-week active treatment phase
Number of heavy drinking days
Tidsramme: Last 4 weeks of treatment (Weeks 5-8)
Number of heavy drinking days (NHDD) during the last four weeks of treatment (treatment Weeks 5-8), as measured by the Timeline Followback interview. NHDD is defined as the total number of days on which participants consumed 5 or more drinks (for males) or 4 or more drinks (for females). The analysis of NHDD will control for baseline NHDD (defined as NHDD in the four weeks preceding treatment).
Last 4 weeks of treatment (Weeks 5-8)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Drinks pr. Drikkedag
Tidsramme: Sidste 4 ugers behandling (uger 5-8)
Drikkevarer pr. Drikkedag (DDD) i løbet af de sidste fire uger af behandlingen (behandlingsuger 5-8) måles ved tidslinjetilfældeinterview. DDD er defineret som et gennemsnitligt antal drikkevarer, der forbruges på drikkedage. Analysen vil kontrollere for baseline DDD (defineret som DDD i de fire uger forud for behandlingen).
Sidste 4 ugers behandling (uger 5-8)
Abstinent dage
Tidsramme: Sidste 4 ugers behandling (uger 5-8)
Abstinent Days (andel af dage, hvor der ikke rapporteres om noget alkoholforbrug) i løbet af de sidste fire ugers behandling (behandling uger 5-8) måles ved tidslinjetilfældningsintervjuet. Analysen vil kontrollere for baseline (defineret som andel af abstinente dage i de fire uger forud for behandlingen).
Sidste 4 ugers behandling (uger 5-8)
Fravær af kraftig drikning
Tidsramme: Sidste 4 ugers behandling (uger 5-8)
Fravær/remission af kraftig drikning i den sidste behandlingsmåned (behandling uger 5-8) måles ved tidslinje efterfølgende interview. Tunge drikkedage defineres som forbrug af 5 eller flere drinks (til mænd) eller 4 eller flere drinks (til kvinder). Ændringen i andelen af ​​deltagere med nul tunge drikkedage fra baseline (defineret som de fire uger forud for behandlingen) til ugerne 5-8 vil blive sammenlignet på tværs af behandlingsgrupper.
Sidste 4 ugers behandling (uger 5-8)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Brown University

Samarbejdspartnere

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. juli 2026

Primær færdiggørelse (Anslået)

31. juli 2028

Studieafslutning (Anslået)

31. juli 2028

Datoer for studieregistrering

Først indsendt

17. juni 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

20. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2023003510
  • 2K24AA026326-06 (U.S. NIH-bevilling/kontrakt)

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