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

NCT07674303 | Not Yet Recruiting DMC

• 2 other identifiers: 2024-0437R01AT012892
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Behavioral Health

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Enrollment

  Baseline

• Randomization

  Baseline

• Retention

  1 month, 6 months

• Health questionnaire completion

  Baseline, 1 month, 6 months

• Acceptability of Intervention Measure (AIM)

  1 month

Other Outcomes (1)

• Ecological momentary assessment (EMA) completion

  Baseline, 1 month

Study Arms (2)

Bodhi AIM

EXPERIMENTAL

Participants randomized to the intervention arm will receive the Bodhi AIM meditation app.

Behavioral: Bodhi AIM

HIB

ACTIVE COMPARATOR

Participants randomized to the active control arm will receive the HIB health promotion app.

Behavioral: HIB

Interventions

Bodhi AIM BEHAVIORAL

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).

Bodhi AIM

HIB BEHAVIORAL

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.

HIB

Eligibility Criteria

• Age: 13 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

Location

Central Study Contacts

Ashley D Kendall, PhD

CONTACT

312-355-1836; akendall@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Both participants and outcome assessors will be blind to condition through completion of the baseline assessments. Condition will become apparent to both participants and assessors at the time of app download, but will not be revealed to assessors at any of the follow-up time points until after the quantitative measures are complete.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: To be determined

Locations

US (1)