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

Not Applicable

Recruiting

• Conditions: Behavioral Health

• Registration Number: NCT06997120
• Lead Sponsor: University of Illinois at Chicago

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. 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?

Detailed Description

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-21
• Study First Posted: 2025-05-30
• Study Start: 2025-06-05
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-11
• Primary Completion: 2029-08-30
• Study Completion: 2029-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cannabis use problems	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
App adherence	1 month	App files played per objective in-app analytics data

Secondary Outcome Measures

Name	Time	Method
Sexual behaviors	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
Negative mood regulation	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
Anxiety	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
Depression	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
Self-efficacy	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
Alcohol use problems	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
Real-time mood states	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)
Real-time cannabis use	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)
Real-time alcohol use	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)

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States