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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2029-08-30

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Behavioral Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Both participants and outcome assessors will be blind to condition through completion of the baseline assessment including the first week-long EMA burst. Condition will become apparent to both participants and assessors at the time of app download, but will not be revealed to assessors at either of the follow-up time points until after the quantitative measures are complete.

Study Groups

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Bodhi AIM

Participants randomized to the intervention arm will receive the Bodhi AIM meditation app.

Group Type EXPERIMENTAL

Bodhi AIM (intervention group)

Intervention Type BEHAVIORAL

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.

HIB

Participants randomized to the active control arm will receive the HIB health promotion app.

Group Type ACTIVE_COMPARATOR

HIB (control group)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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 parental consent (if under 18 years old)
* English-speaking, due to norming of instruments

Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes