Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02912, United States
Location status: Recruiting
Location contact
Kristin Rogers, MS
CONTACT
Robert Miranda, PhD
CONTACT
NCT Number: NCT07713251
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.
Interested in participating?
Request Info13 year–19 year
All sexes
Interventional
Not applicable
Providence, Rhode Island, 02912, United States
Location status: Recruiting
Kristin Rogers, MS
CONTACT
Robert Miranda, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 8-week active treatment phase
The number of participants who complete the active treatment phase will determine feasibility.
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%.
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).
Time frame: Last 4 weeks of treatment (Weeks 5-8)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
Kristin Rogers, MS
CONTACT
Robert Miranda, PhD
CONTACT
Brown University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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