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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-20
SponsorUniversity of Illinois at Chicago

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Bodhi AIMExperimental treatment 1 intervention
Group B: HIBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
baseline, 1 month, 6 months
2

App adherence

App files played per objective in-app analytics data

Time frame
1 month

Secondary outcomes

1

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

Time frame
baseline, 1 month, 6 months
2

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

Time frame
baseline, 1 month, 6 months
3

Anxiety

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

Time frame
baseline, 1 month, 6 months
4

Depression

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

Time frame
baseline, 1 month, 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator