NCT05146167

Brief Summary

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. 1.Will youth adequately adhere to the 1-month meditation app?
  2. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 6, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

April 5, 2022

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2025

Completed
Last Updated

November 10, 2025

Status Verified

April 1, 2025

Enrollment Period

3.5 years

First QC Date

November 8, 2021

Last Update Submit

November 5, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Percentage of participants who complete other substance use measures at each time point

    Baseline, 1 month, 6 months

  • Percentage of participants who complete other mental health measures at each time point

    Baseline, 1 month, 6 months

Other Outcomes (1)

  • Percentage of participants who complete other outcome measures at each time point

    Baseline, 1 month, 6 months

Study Arms (2)

Bodhi AIM

EXPERIMENTAL

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

Behavioral: Bodhi AIM (intervention group)

HIB

ACTIVE COMPARATOR

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

Behavioral: HIB (control group)

Interventions

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 (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

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ashley D Kendall, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

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 assessment. Condition will become apparent to both participants and assessors at the time of app download, but will not be revealed to assessors at either of the follow-up time points until after the quantitative measures are complete.
Purpose
PREVENTION
Intervention Model
PARALLEL
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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 8, 2021

First Posted

December 6, 2021

Study Start

April 5, 2022

Primary Completion

October 15, 2025

Study Completion

October 15, 2025

Last Updated

November 10, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

De-identified data may be made available upon reasonable request.

Locations