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

NCT06997120 | Recruiting DMC

• 2 other identifiers: 2025-0066R01DA061795
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Is the meditation app associated with improvements in behavioral health outcomes including cannabis use problems?
2. 2.Do improvements in emotion regulation appear to mediate the effects of the meditation app on these behavioral health outcomes?
3. 3.Will youth adequately adhere to the meditation app?

Conditions

Behavioral Health

Keywords

Juvenile legal system; Meditation; Mindfulness; Smartphone; Mobile health (mHealth); Ecological momentary assessment (EMA); Substance use; Mental health

Outcome Measures

Primary Outcomes (2)

• Cannabis use problems

  The Cannabis Use Disorder Identification Test - Revised (CUDIT-R) includes 8 items, each rated on a 4-point scale; higher total scores indicate greater cannabis use problems

  baseline, 1 month, 6 months

• App adherence

  App files played per objective in-app analytics data

  1 month

Secondary Outcomes (9)

• Sexual behaviors

  baseline, 1 month, 6 months

• Negative mood regulation

  baseline, 1 month, 6 months

• Anxiety

  baseline, 1 month, 6 months

• Depression

  baseline, 1 month, 6 months

• Self-efficacy

  baseline, 1 month, 6 months

Study Arms (2)

Bodhi AIM

EXPERIMENTAL

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

Behavioral: Bodhi AIM (intervention group)

HIB

ACTIVE COMPARATOR

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

Behavioral: HIB (control group)

Interventions

HIB (control group) 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.

HIB

Bodhi AIM (intervention group) 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.

Bodhi AIM

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders; Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 30, 2025
• Study Start: June 5, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): May 31, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data sharing will generally coincide with publication of the study's main findings and is intended to take place within 1 year after acceptance of the primary manuscripts.
• Access Criteria: To be determined

Locations

US (1)