Alcohol Use DisorderNCT07713251
Supporting Adolescent Alcohol Treatment With Computer-Based ('Path180') Skills Training
A study testing Path180 in people with Alcohol Use Disorder, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Path180
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2026to 31 Jul 2028
- 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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02912
Robert Miranda, PhD, 401 863-6658, Robert_Miranda_Jr@brown.edu
Kristin Rogers, MS, 401-863-6463, kristin_rogers@brown.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Path180
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Path180Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Path180 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who complete the active treatment phase
The number of participants who complete the active treatment phase will determine feasibility.
Measured: 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%.
Measured: 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).
Measured: Last 4 weeks of treatment (Weeks 5-8)
Secondary outcomes (3)
Drinks per drinking day
Drinks per drinking day (DDD) during the last four weeks of treatment (treatment Weeks 5-8) will be measured by the Timeline Followback interview. DDD is defined as average number of drinks consumed on drinking days. The analysis will control for baseline DDD (defined as DDD in the four weeks preceding treatment).
Measured: Last 4 weeks of treatment (Weeks 5-8)
Abstinent days
Abstinent days (proportion of days on which no alcohol consumption is reported) during the last four weeks of treatment (treatment Weeks 5-8) will be measured by the Timeline Followback interview. The analysis will control for baseline (defined as proportion of abstinent days in the four weeks preceding treatment).
Measured: Last 4 weeks of treatment (Weeks 5-8)
Absence of heavy drinking
Absence/remission of heavy drinking in the last month of treatment (treatment Weeks 5-8) will be measured by the Timeline Followback interview. Heavy drinking days are defined as consuming 5 or more drinks (for men) or 4 or more drinks (for women). The change in the proportion of participants with zero heavy drinking days from baseline (defined as the four weeks preceding treatment) to the Weeks 5-8 will be compared across treatment groups.
Measured: Last 4 weeks of treatment (Weeks 5-8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start7 Jul 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713251
- Sponsor's protocol ID
- 2023003510
- Other IDs
- 2K24AA026326-06
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Adolescent Alcohol Treatment With Computer-Based ('Path180') Skills Training
- ClinicalTrials.gov ID
- NCT07713251
- Acronym / sponsor ID
- 2023003510
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 20 Jul 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Treatment | No intervention | –Participants randomized to Standard Treatment will receive treatment as usual at a behavioral healthcare facility. |
| Path180 | Experimental | Behavioral: Path180Youth randomized to this condition will have unlimited access to the Path180 platform throughout the 8-week skills training period. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Path180Path180 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. | Behavioural | Path180 |
Primary outcome
Number of participants who complete the active treatment phase
Time frame: 8-week active treatment phase
The number of participants who complete the active treatment phase will determine feasibility.
Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8
Time frame: 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%.
Number of heavy drinking days
Time frame: 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).
3 secondary outcomes
Drinks per drinking day
Time frame: Last 4 weeks of treatment (Weeks 5-8)
Abstinent days
Time frame: Last 4 weeks of treatment (Weeks 5-8)
Absence of heavy drinking
Time frame: Last 4 weeks of treatment (Weeks 5-8)
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 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Path180 in people with Alcohol Use Disorder, run by Brown University 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 9 inclusion and 3 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 20 Jul 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. 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 Robert Miranda, PhD (401-863-6658, Robert_Miranda_Jr@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who complete the active treatment phase (time frame: 8-week active treatment phase). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.