[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07713251":3,"trial-entities:NCT07713251":104,"trial-summary:NCT07713251":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":45,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":14,"eligibility_criteria":58,"std_ages":74,"locations":77,"central_contacts":97,"overall_officials":101,"references":102,"see_also_links":103},"NCT07713251","2023003510","Supporting Adolescent Alcohol Treatment With Computer-Based ('Path180') Skills Training","RECRUITING","2028-07-31","2026-06","2026-07-20","2026-07-07","Brown University","OTHER",true,"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.","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.",[18],"Alcohol Use Disorder",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},112,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","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.",[30],[34,38,41],{"measure":35,"description":36,"timeFrame":37},"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",{"measure":39,"description":40,"timeFrame":37},"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%.",{"measure":42,"description":43,"timeFrame":44},"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)",[46,49,52],{"measure":47,"description":48,"timeFrame":44},"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).",{"measure":50,"description":51,"timeFrame":44},"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).",{"measure":53,"description":54,"timeFrame":44},"Absence of heavy drinking","Absence\u002Fremission 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.","ALL","13 Years","19 Years",{"inclusion":59,"exclusion":69,"raw_text":73},[60,61,62,63,64,65,66,67,68],"Ages 13 to 19 years, inclusive; we will exclude children \\\u003C 13 due to diversity across adolescence and youths \\> 19 because our focus is teenagers","Seeking\u002Freceiving mental health counseling and\u002For outpatient substance use disorder treatment at Bradley Hospital or another national clinic\u002Ftreatment 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\u002Fassent form, and provide written informed consent\u002Fassent","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\u002Fshe\u002Fthey will be able to attend each scheduled visit, participate in phone visits and that he\u002Fshe\u002Fthey 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.",[70,71,72],"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.","Inclusion Criteria:\n\n* Ages 13 to 19 years, inclusive; we will exclude children \\\u003C 13 due to diversity across adolescence and youths \\> 19 because our focus is teenagers\n* Seeking\u002Freceiving mental health counseling and\u002For outpatient substance use disorder treatment at Bradley Hospital or another national clinic\u002Ftreatment service\n* Self-reported alcohol use in the past year\n* 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)\n* Able to understand written and oral instructions in English, communicate understanding of the consent\u002Fassent form, and provide written informed consent\u002Fassent\n* Complete all assessments required at screening.\n* 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.\n* Agree to the schedule of visits, verbally acknowledge that he\u002Fshe\u002Fthey will be able to attend each scheduled visit, participate in phone visits and that he\u002Fshe\u002Fthey does not have any already scheduled events or a job that may substantially interfere with study participation.\n* 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.\n\nExclusion Criteria:\n\n* 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\n* DSM-5 criteria for a severe SUD besides alcohol, cannabis and tobacco\n* 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.",[75,76],"CHILD","ADULT",[78],{"facility":79,"status":7,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":94},"Brown University Center for Alcohol and Addiction Studies","Providence","Rhode Island","02912","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Robert Miranda, PhD","CONTACT","401 863-6658","Robert_Miranda_Jr@brown.edu",{"name":91,"role":87,"phone":92,"email":93},"Kristin Rogers, MS","401-863-6463","kristin_rogers@brown.edu",{"lat":95,"lon":96},41.82399,-71.41283,[98,100],{"name":86,"role":87,"phone":99,"email":89},"401-863-6658",{"name":91,"role":87,"phone":92,"email":93},[],[],[],{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Alcohol use disorder",[],{"nct_id":4,"found":14,"summary":109,"prompt_version":119},{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an interventional study with 112 participants. You would be randomly assigned to one of two groups: standard treatment or standard treatment plus Path180.","completed","Supporting Adolescent Alcohol Treatment with Path180","This 8-week study is for teenagers aged 13 to 19 who are receiving mental health counseling or outpatient substance use treatment and have used alcohol in the past year. It tests a computer-based skills training program called Path180, designed specifically for teens. You would be randomly assigned to either receive your usual treatment or your usual treatment plus Path180. Researchers want to see if Path180 helps reduce heavy drinking days and if participants find the program satisfactory. The study aims to enroll 112 participants to understand if digital tools can improve treatment for young people with alcohol use disorder.","The study measures outcomes like heavy drinking days at the end of the 8-week active treatment phase (weeks 5-8).",99,"If assigned to Path180, you would complete one module of the program at each of the first 7 weekly Check-in Visits. The active treatment phase lasts 8 weeks.","Not stated in the trial record.",[30],"v2"]