Clinical trial NCT06997120: Testing the Effectiveness and Implementation of a Meditation App for Youth in the Legal System
Official title: Effectiveness and Implementation of a Meditation App Addressing Substance Use, Sexual Health, and Emotion Regulation Among Legal-Involved Youth
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Behavioral Health
Keywords: Juvenile legal system
Meditation
Mindfulness
Smartphone
Mobile health (mHealth)
Ecological momentary assessment (EMA)
Substance use
Mental health
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-30
Enrollment: 300
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cannabis use problems
timeFrame: baseline, 1 month, 6 months
measure: App adherence
timeFrame: 1 month
Secondary outcomes:
measure: Sexual behaviors
timeFrame: baseline, 1 month, 6 months
measure: Negative mood regulation
timeFrame: baseline, 1 month, 6 months
measure: Anxiety
timeFrame: baseline, 1 month, 6 months
measure: Depression
timeFrame: baseline, 1 month, 6 months
measure: Self-efficacy
timeFrame: baseline, 1 month, 6 months
measure: Alcohol use problems
timeFrame: baseline, 1 month, 6 months
measure: Real-time mood states
timeFrame: baseline, 1 month
measure: Real-time cannabis use
timeFrame: baseline, 1 month
measure: Real-time alcohol use
timeFrame: baseline, 1 month
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References: