Supporting Adolescent Alcohol Treatment With Computer-Based ('Path180') Skills Training
ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-19
SponsorBrown University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Path180
BehavioralPath180 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.
Treatment groups
112 Participants
are divided into 2 treatment groupsGroup A: Standard TreatmentNo intervention 0 interventions
Group B: Path180Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants who complete the active treatment phase
The number of participants who complete the active treatment phase will determine feasibility.
Time frame
8-week active treatment phase2
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%.
Time frame
8-week active treatment phase3
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).
Time frame
Last 4 weeks of treatment (Weeks 5-8)Secondary outcomes
1
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).
Time frame
Last 4 weeks of treatment (Weeks 5-8)2
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).
Time frame
Last 4 weeks of treatment (Weeks 5-8)3
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.
Time frame
Last 4 weeks of treatment (Weeks 5-8)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brown University
Lead sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Source ClinicalTrials.gov