Testing a Meditation App With Justice-Involved Youth on Probation

Emotion Regulation Clinical Trial

— ProjectAIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146167
• Other study ID #: 2018-0889
• Secondary ID: R00DA047890
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2022
• Est. completion date: February 28, 2025

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: Ashley D Kendall, PhD
• Phone: (312) 355-1836
• Email: akendall[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Alcohol Use
• Cannabis Use
• Emotion Regulation
• Sexual Behavior

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Digital Working Alliance	Digital Working Alliance as measured by the Digital Working Alliance Inventory [At 1-month follow-up]	1-month follow-up
Secondary	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