Testing the Effectiveness and Implementation of a Meditation App for Youth in the Legal System

Официальное название

Effectiveness and Implementation of a Meditation App Addressing Substance Use, Sexual Health, and Emotion Regulation Among Legal-Involved Youth

Обзор

The goals of this hybrid type 2 randomized controlled trial (RCT) are to evaluate the effectiveness and individual-level implementation of a 1-month app-based meditation program with youth on probation in Cook County, IL. The primary questions it is designed to answer are: 1. Is the meditation app associated with improvements in behavioral health outcomes including cannabis use problems? 2. Do improvements in emotion regulation appear to mediate the effects of the meditation app on these behavioral health outcomes? 3. Will youth adequately adhere to the meditation app?

Подробное описание

This remote study will enroll 300 youth on probation in Cook County, IL, which encompasses Chicago and its surrounding suburbs. Youth will be individually randomized to use either the meditation app or an active control app matched for time/structure daily for 30 days. Health outcomes will be self-reported at baseline, 1 month, and 6 months, and in real time via 1-week "bursts" of ecological momentary assessment (EMA) at baseline and 1 month (i.e., approximately overlapping with the last week of app use). Objective adherence to both apps will be captured automatically via in-app analytics.

Вмешательства

• Поведенческое Bodhi AIM (intervention group)
  AIM (Action In Mindfulness) is a smartphone app that teaches users to establish a daily meditation practice via a 30-day "path," with each day consisting of a brief audio- or video-guided file. In addition to the 30 daily path files, users have access to a menu of "to go" audio-guided meditation practices that they may access any time to prepare for particular situations.
• Поведенческое HIB (control group)
  HIB (Health In Balance) is a smartphone app that is matched to AIM for time and structure, but includes health promotion content (e.g., educational information on substance use) in place of the meditation content featured in AIM. Like AIM, HIB includes a 30-day "path" of audio and video files, along with a menu of "to go" audio files that users may access any time to review key intervention concepts.

Первичные конечные точки

• Cannabis use problems [Срок оценки: baseline, 1 month, 6 months]
• App adherence [Срок оценки: 1 month]

Вторичные конечные точки (9)

• Sexual behaviors [Срок оценки: baseline, 1 month, 6 months]
• Negative mood regulation [Срок оценки: baseline, 1 month, 6 months]
• Anxiety [Срок оценки: baseline, 1 month, 6 months]
• Depression [Срок оценки: baseline, 1 month, 6 months]
• Self-efficacy [Срок оценки: baseline, 1 month, 6 months]
• Alcohol use problems [Срок оценки: baseline, 1 month, 6 months]
• Real-time mood states [Срок оценки: baseline, 1 month]
• Real-time cannabis use [Срок оценки: baseline, 1 month]
• Real-time alcohol use [Срок оценки: baseline, 1 month]

Критерии участия

Критерии включения

• 13-20 years old
• In probation programming (i.e., in legal programming but not detained) in Cook County
• Have access to an Apple/Android smartphone
• Understand and provide assent/consent
• Have legal guardian permission (if under 18 years old)
• English-speaking, due to norming of instruments

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

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Illinois at Chicago — Chicago

Идентификаторы

NCT: NCT06997120 · 2025-0066 · R01DA061795

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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