Testing a Meditation App With Justice-Involved Youth on Probation (Project AIM)

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

This study is a randomized controlled trial (RCT) testing the effects of a mindfulness-based intervention delivered to justice-involved youth on probation via smartphone app on youths' emotion regulation and HIV/sexually transmitted infection (STI) risk-taking behaviors (i.e., alcohol use, cannabis use, sexual behaviors, and aggressive behaviors).

Study Overview

• Status: Recruiting
• Conditions: Aggression; Alcohol Use; Sexual Behavior; Cannabis Use; Emotion Regulation
• Intervention / Treatment: Behavioral: Bodhi AIM (intervention group); Behavioral: HIB (control group)

Detailed Description

The investigators will enroll 200 justice-involved youth on probation 13-18 years old of all genders 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 mindfulness-based intervention, 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• 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
      • Recruiting
      • University of Illinois at 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: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 13-18 years old
• On probation in the Chicago Cook County Juvenile Justice System

Exclusion Criteria:

• Unable to understand the permission/consent/assent process
• Do not speak English, due to norming of instruments
• Do not assent/consent
• Legal guardian does not give permission for youth's participation if under 18 years old
• Do not have an Apple or Android phone
• Are detained
• Are in care of DCFS

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 group will receive the Bodhi AIM 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 health promotion control group will receive the HIB 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
Changes in Negative Emotion Regulation	Changes in Negative Emotion Regulation as measured by the Negative Mood Regulation Scale [At baseline, 1-month follow-up, and 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Alcohol Use	Changes in Alcohol Use as measured by the Young Adult Alcohol Problem Scale [6-month time period at baseline, 1-month time period at 1-month follow-up, 6-month time period at 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Cannabis Use	Changes in Cannabis Use as measured by the Cannabis Use Disorders Identification Test - Revised [6-month time period at baseline, 1-month time period at 1-month follow-up, 6-month time period at 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Sexual Behavior	Changes in Sexual Behavior as measured by a modified version of the AIDS Risk Behavior Assessment [6-month time period at baseline, 1-month time period at 1-month follow-up, 6-month time period at 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Aggression	Changes in Aggression as measured by the Reactive-Proactive Aggression Questionnaire [At baseline, 1-month follow-up, and 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Positive Emotion Regulation	Changes in Positive Emotion Regulation as measured by the Connor-Davidson Resilience Scale 10 [1-month time period at baseline, 1-month follow-up, and 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Mindfulness	Changes in Mindfulness as measured by the Five Facets of Mindfulness Questionnaire [At baseline, 1-month follow-up, and 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Alcohol Trouble	Changes in Alcohol Trouble as measured by the Alcohol Trouble Scale [6-month time period at baseline, 1-month time period at 1-month follow-up, 6-month time period at 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Hangover Symptoms	Changes in Hangover Symptoms as measured by the Hangover Symptoms Scale [6-month time period at baseline, 1-month time period at 1-month follow-up, 6-month time period at 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Substance Use Attitudes and Beliefs	Changes in Substance Use Attitudes and Beliefs as measured by a modified version of the Alcohol Abstinence Self-Efficacy Scale [At baseline, 1-month follow-up, and 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Additional Facets of Aggression	Changes in Additional Facets of Aggression as measured by the Short-Form Buss-Perry Aggression Questionnaire [At baseline, 1-month follow-up, and 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Mental Health Symptoms	Changes in Mental Health Symptoms as measured by the Youth Self-Report (YSR) [6-month time period at baseline, 1-month time period at 1-month follow-up, 6-month time period at 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
Changes in Trauma Symptoms	Changes in Trauma Symptoms as measured by the UCLA PTSD Rating Index [1-month time period at baseline, 1-month follow-up, and 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up
App Usage	App Usage as assessed by objective app usage data (date/time stamps for each app feature) [Up through 6-month follow-up]	Up through 6-month follow-up
Digital Working Alliance	Digital Working Alliance as measured by the Digital Working Alliance Inventory [At 1-month follow-up]	1-month follow-up
Juvenile Justice Involvement	Juvenile Justice Involvement (i.e., number of arrests, charge(s), number of detainments) [Lifetime time period at baseline, 1-month time period at 1-month follow-up, 6-month time period at 6-month follow-up]	Baseline, 1-month follow-up, 6-month follow-up

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 (Anticipated): February 28, 2024
• Study Completion (Anticipated): February 28, 2024

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 (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 9, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; HIV prevention; mHealth; Juvenile justice
• Additional Relevant MeSH Terms: Behavioral Symptoms; Aggression
• 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 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