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NCT Number: NCT06997120

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

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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Key information

Conditions

Behavioral Health Behavior Chemically-Induced Disorders Mental Disorders Personal Satisfaction Psychological Well-Being Substance-Related Disorders

Age range

13 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Ashley D Kendall, PhD

CONTACT

[email protected]

312-355-1836

Ashley D Kendall, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 legal guardian permission (if under 18 years old)
  • English-speaking, due to norming of instruments

Treatment and study plan

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.

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.

Primary outcomes

  1. Cannabis use problems

    Time frame: baseline, 1 month, 6 months

    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

  2. App adherence

    Time frame: 1 month

    App files played per objective in-app analytics data

Secondary outcomes

  1. Sexual behaviors

    Time frame: baseline, 1 month, 6 months

    A modified AIDS Risk Behavior Assessment (ARBA) will be used to create a sexual behavior summary score; higher scores indicate more sexual risk behaviors

  2. Negative mood regulation

    Time frame: baseline, 1 month, 6 months

    The Negative Mood Regulation (NMR) scale includes 14 items, each rated on a 5-point scale; higher total scores indicate greater beliefs one can regulate negative mood states

  3. Anxiety

    Time frame: baseline, 1 month, 6 months

    The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of anxiety; higher total scores indicate greater anxiety symptoms

  4. Depression

    Time frame: baseline, 1 month, 6 months

    The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of depression; higher total scores indicate greater depression symptoms

  5. Self-efficacy

    Time frame: baseline, 1 month, 6 months

    The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of self-efficacy; higher total scores indicate greater sense of self-efficacy

  6. Alcohol use problems

    Time frame: baseline, 1 month, 6 months

    The Alcohol Trouble Scale (ATS) includes 10 items, each rated on a binary (yes/no) scale; higher scores indicate greater alcohol use problems

  7. Real-time mood states

    Time frame: baseline, 1 month

    The International Positive Affect Negative Affect Schedule Short Form (I-PANAS-SF) includes 10 items, each rated on a 5-point scale; higher total scores indicate greater positive or negative moods, respectively at the time of ecological momentary assessment (EMA)

  8. Real-time cannabis use

    Time frame: baseline, 1 month

    2 items indicating yes/no to cannabis use (1) now and (2) in the past 3 hours at the time of ecological momentary assessment (EMA)

  9. Real-time alcohol use

    Time frame: baseline, 1 month

    2 items indicating yes/no to alcohol use (1) now and (2) in the past 3 hours at the time of ecological momentary assessment (EMA)

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
May 30, 2025
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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