About this trial
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?
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Bodhi AIM (intervention group)
BehavioralAIM (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)
BehavioralHIB (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.
Treatment groups
Trial outcomes
Primary outcomes
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
App adherence
App files played per objective in-app analytics data
Secondary outcomes
Sexual behaviors
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
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
The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of anxiety; higher total scores indicate greater anxiety symptoms
Depression
The PROMIS Pediatric Item Bank GenPop v3.0 is a computer adaptive measure of depression; higher total scores indicate greater depression symptoms
Sponsors and contacts
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University of Illinois at Chicago
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator