Feasibility Testing a Meditation App for Youth in the Legal System (ProjectAIM)

Reducing HIV/Sexually Transmitted Infection (STI) Risk Behaviors Among Juvenile Offenders on Probation: A Mobile Mindfulness-Based Intervention

This feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in the juvenile legal system. The primary questions it is designed to answer are:

1. Will youth adequately adhere to the 1-month meditation app?
2. Is it feasible to collect data remotely from youth on their self-reported cannabis use, sexual health, and mental health at baseline, 1, and 6 months?

Study Overview

• Status: Completed
• Conditions: Behavioral Health
• Intervention / Treatment: Behavioral: Bodhi AIM (intervention group); Behavioral: HIB (control group)

Detailed Description

The investigators aim enroll 100 youth in Cook County, IL 13-18 years old who report regular access to an Apple or Android smartphone. Following completion of a baseline questionnaire, 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. Follow-up assessments will occur at 1 and 6 months. All study activities will be remote.

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 13-18 years old
• In probation programming (i.e., in legal programming but not detained) in Cook County, IL
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bodhi AIM; Participants randomized to the intervention arm will receive the Bodhi AIM meditation app.	Behavioral: Bodhi AIM (intervention group); Bodhi AIM (Action In Mindfulness) is a smartphone-based 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 (e.g., attending a party).
Active Comparator: HIB; Participants randomized to the active control arm will receive the HIB health promotion app.	Behavioral: HIB (control group); HIB (Health In Balance) is a smartphone-based app that is matched to Bodhi 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 Bodhi AIM. Like Bodhi 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
App adherence	Days of objective app usage	1 month
Percentage of participants who complete the cannabis use measure at each time point	Cannabis use is measured with the Cannabis Use Disorders Identification Test-Revised	Baseline, 1 month, 6 months
Percentage of participants who complete the sexual health measure at each time point	Sexual health is measured with a modified version of the AIDS Risk Behavior Assessment	Baseline, 1 month, 6 months
Percentage of participants who complete the mental health symptoms measure at each time point	Mental health symptoms are measured with the Youth Self Report	Baseline, 1 month, 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who complete other substance use measures at each time point	The other substance use measures include the Young Adult Alcohol Problem Scale, the Alcohol Trouble Scale, the Hangover Symptoms Scale, and a modified Substance Use Self-Efficacy Scale	Baseline, 1 month, 6 months
Percentage of participants who complete other mental health measures at each time point	The other mental health measures include the Reactive-Proactive Aggression Questionnaire, the Short-Form Buss-Perry Aggression Questionnaire, the Negative Mood Regulation Scale, the Connor-Davidson Resilience Scale-10, and the Five Facets of Mindfulness Questionnaire-15	Baseline, 1 month, 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants who complete other outcome measures at each time point	The other outcome measures include self-reported legal system involvement (e.g., frequencies of arrests and detainments), the UCLA PTSD Rating Index, and the Digital Working Alliance Inventory (measured at 1 month and 6 months only)	Baseline, 1 month, 6 months

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Ashley D Kendall, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2022
• Primary Completion (Actual): October 15, 2025
• Study Completion (Actual): October 15, 2025

Study Registration Dates

• First Submitted: November 8, 2021
• First Submitted That Met QC Criteria: November 23, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Estimated): November 7, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Mindfulness; HIV prevention; mHealth; Juvenile justice
• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Aggression; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 2018-0889; R00DA047890 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data may be made available upon reasonable request.
• IPD Sharing Time Frame: Data sharing will generally coincide with publication of the study's main findings and is intended to take place within 1 year after acceptance of the primary manuscripts.
• IPD Sharing Access Criteria: To be determined
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No