Testing a Meditation App With Justice-Involved Youth on Probation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Emotion Regulation, Alcohol Use, Cannabis Use, Sexual Behavior, Aggression

Intervention / Treatment
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* Behavioral: Bodhi AIM (intervention group)
* Behavioral: HIB (control group)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bodhi AIM<br>Participants randomized to the intervention group will receive the Bodhi AIM app | Behavioral: Bodhi AIM (intervention group)<br>* 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).<br>|
| Active Comparator: HIB<br>Participants randomized to the health promotion control group will receive the HIB app | Behavioral: HIB (control group)<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, Juvenile justice, Mindfulness, mHealth