Supporting Adolescent Alcohol Treatment With Computer-Based ('Path180') Skills Training

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 interac

Первичные конечные точки

• Number of participants who complete the active treatment phase [Срок оценки: 8-week active treatment phase]
• Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8 [Срок оценки: 8-week active treatment phase]
• Number of heavy drinking days [Срок оценки: Last 4 weeks of treatment (Weeks 5-8)]

Вторичные конечные точки (3)

• Drinks per drinking day [Срок оценки: Last 4 weeks of treatment (Weeks 5-8)]
• Abstinent days [Срок оценки: Last 4 weeks of treatment (Weeks 5-8)]
• Absence of heavy drinking [Срок оценки: Last 4 weeks of treatment (Weeks 5-8)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brown University Center for Alcohol and Addiction Studies — Providence

Идентификаторы

NCT: NCT07713251 · 2023003510 · 2K24AA026326-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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