NCT07713251

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Jul 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Jul 2026Jul 2028

First Submitted

Initial submission to the registry

June 17, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

July 7, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

July 20, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

June 17, 2026

Last Update Submit

July 14, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of participants who complete the 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

    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

    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)

Secondary Outcomes (3)

  • Drinks per drinking day

    Last 4 weeks of treatment (Weeks 5-8)

  • Abstinent days

    Last 4 weeks of treatment (Weeks 5-8)

  • Absence of heavy drinking

    Last 4 weeks of treatment (Weeks 5-8)

Study Arms (2)

Standard Treatment

NO INTERVENTION

Participants randomized to Standard Treatment will receive treatment as usual at a behavioral healthcare facility.

Path180

EXPERIMENTAL

Youth randomized to this condition will have unlimited access to the Path180 platform throughout the 8-week skills training period.

Behavioral: Path180

Interventions

Path180BEHAVIORAL

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.

Path180

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02912, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Robert Miranda, PhD

CONTACT

Kristin Rogers, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

July 20, 2026

Study Start

July 7, 2026

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

July 20, 2026

Record last verified: 2026-06

Locations