Multi-Site Feasibility Testing a Meditation App for Youth in the Legal System

Официальное название

Improving Psychological Wellbeing and Decreasing Psychological Distress Among Youth in the Legal System: Multi-Site Feasibility Trial of a Mindfulness Meditation App

Обзор

This multi-site feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in 4 heterogeneous juvenile legal systems across Oregon and New York. The primary question it is designed to answer is: Will youth adequately adhere to the 1-month meditation app across sites? Secondary feasibility outcomes pertain to recruitment, randomization, retention, and survey completion.

Подробное описание

The investigators aim to enroll 120 youth (30/site) 13-20 years old who report regular access to an Apple or Android smartphone. Following completion of a baseline survey, participants will be individually randomized at a 1:1 ratio to 1 of 2 smartphone app conditions: (1) Bodhi AIM (Action In Mindfulness), a 30-day meditation app or (2) HIB (Health In Balance), a health promotion control app matched to Bodhi AIM for time and structure. Follow-up assessments will occur at 1 and 6 months. All study activities will be remote.

Вмешательства

• Поведенческое Bodhi AIM
  Bodhi AIM (Action In Mindfulness) is a smartphone-based 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 (e.g., attending a party).
• Поведенческое HIB
  HIB (Health In Balance) is a smartphone-based app that is matched to Bodhi 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 Bodhi AIM. Like Bodhi 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

• App adherence (binary) [Срок оценки: 1 month]
• App adherence (continuous) [Срок оценки: 1 month]

Вторичные конечные точки (7)

• Enrollment [Срок оценки: Baseline]
• Randomization [Срок оценки: Baseline]
• Retention [Срок оценки: 1 month, 6 months]
• Health questionnaire completion [Срок оценки: Baseline, 1 month, 6 months]
• Acceptability of Intervention Measure (AIM) [Срок оценки: 1 month]
• Intervention Appropriateness Measure (IAM) [Срок оценки: 1 month]
• Feasibility of Intervention Measure (FIM) [Срок оценки: 1 month]

Критерии участия

Критерии включения

• 13-20 years old
• In probation or related programming (i.e., in legal programming but not detained) in Oregon or New York State
• 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 исключения

\- There are no exclusion criteria.

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 Chicago — Chicago

Идентификаторы

NCT: NCT07674303 · 2024-0437 · R01AT012892

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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