Multi-Site Feasibility Testing a Meditation App for Youth in the Legal System

Improving Psychological Wellbeing and Decreasing Psychological Distress Among Youth in the Legal System: Multi-Site Feasibility Trial of a Mindfulness Meditation App

This multi-site feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in 4 heterogeneous juvenile legal systems across Oregon and New York. The primary question it is designed to answer is: Will youth adequately adhere to the 1-month meditation app across sites? Secondary feasibility outcomes pertain to recruitment, randomization, retention, and survey completion.

Study Overview

• Status: Not yet recruiting
• Conditions: Behavioral Health
• Intervention / Treatment: Behavioral: Bodhi AIM; Behavioral: HIB

Detailed Description

The investigators aim to enroll 120 youth (30/site) 13-20 years old who report regular access to an Apple or Android smartphone. Following completion of a baseline survey, 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 (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley D Kendall, PhD; Phone Number: 312-355-1836; Email: akendall@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Chicago
      • Contact: Ashley D Kendall, PhD; Phone Number: 312-355-1836; Email: akendall@uic.edu
      • Principal Investigator: Ashley D Kendall, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 13-20 years old
• In probation or related programming (i.e., in legal programming but not detained) in Oregon or New York State
• 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

Exclusion Criteria:

- There are no exclusion criteria.

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; 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; 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 (binary)	Percentage of participants who play at least one file on their study app after baseline.	1 month
App adherence (continuous)	Average number of daily app files played over the 1-month intervention period.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment	Number of participants enrolled	Baseline
Randomization	Percentage of participants randomized to each arm who play at least one app file	Baseline
Retention	Percentage of participants who attend (yes/no) each follow-up visit	1 month, 6 months
Health questionnaire completion	Percentage of participants who complete the questionnaire measures of psychological wellbeing (PROMIS Pediatric Bank v1.0 Positive Affect, NIH Toolbox Pediatric Item Bank v3.0 Self-Efficacy CAT) and psychological distress (PROMIS Pediatric Item Bank GenPop v3.0 Anxiety, PROMIS Pediatric Item Bank GenPop v3.0 Depressive Symptoms, PROMIS Pediatric Bank v 1.0 Psychological Stress Experiences) at each time point	Baseline, 1 month, 6 months
Acceptability of Intervention Measure (AIM)	Four-item scale assessing perceived acceptability of the intervention. Items are rated on a 5-point Likert scale and averaged to produce a total score ranging from 1 to 5; with higher scores indicating greater acceptability.	1 month
Intervention Appropriateness Measure (IAM)	Four-item scale assessing perceived appropriateness of the intervention. Items are rated on a 5-point Likert scale and averaged to produce a total score ranging from 1 to 5; with higher scores indicating greater appropriateness.	1 month
Feasibility of Intervention Measure (FIM)	Four-item scale assessing perceived feasibility of the intervention. Items are rated on a 5-point Likert scale and averaged to produce a total score ranging from 1 to 5; with higher scores indicating greater feasibility.	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ecological momentary assessment (EMA) completion	Percentage of EMA reports made out of total EMA prompts sent at each EMA burst	Baseline, 1 month

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 29, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2024-0437; R01AT012892 (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 placed in one or more electronic databases which could be used for other research studies.
• 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