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

Primary Purpose

Emotion Regulation, Alcohol Use, Cannabis Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bodhi AIM (intervention group)
HIB (control group)
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emotion Regulation focused on measuring HIV prevention, Juvenile justice, Mindfulness, mHealth

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Illinois at ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bodhi AIM

HIB

Arm Description

Participants randomized to the intervention group will receive the Bodhi AIM app

Participants randomized to the health promotion control group will receive the HIB app

Outcomes

Primary Outcome Measures

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]
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]
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]
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]
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]

Secondary Outcome Measures

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]
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]
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]
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]
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]
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]
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]
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]
App Usage
App Usage as assessed by objective app usage data (date/time stamps for each app feature) [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]
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]

Full Information

First Posted
November 8, 2021
Last Updated
January 9, 2023
Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05146167
Brief Title
Testing a Meditation App With Justice-Involved Youth on Probation
Acronym
Project AIM
Official Title
Reducing HIV/Sexually Transmitted Infection (STI) Risk Behaviors Among Juvenile Offenders on Probation: A Mobile Mindfulness-Based Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotion Regulation, Alcohol Use, Cannabis Use, Sexual Behavior, Aggression
Keywords
HIV prevention, Juvenile justice, Mindfulness, mHealth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Masking Description
Outcomes assessors will be masked to arm through completion of outcome assessments.
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bodhi AIM
Arm Type
Experimental
Arm Description
Participants randomized to the intervention group will receive the Bodhi AIM app
Arm Title
HIB
Arm Type
Active Comparator
Arm Description
Participants randomized to the health promotion control group will receive the HIB app
Intervention Type
Behavioral
Intervention Name(s)
Bodhi AIM (intervention group)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
HIB (control group)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Negative Emotion Regulation
Description
Changes in Negative Emotion Regulation as measured by the Negative Mood Regulation Scale [At baseline, 1-month follow-up, and 6-month follow-up]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Alcohol Use
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Cannabis Use
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Sexual Behavior
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Aggression
Description
Changes in Aggression as measured by the Reactive-Proactive Aggression Questionnaire [At baseline, 1-month follow-up, and 6-month follow-up]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Secondary Outcome Measure Information:
Title
Changes in Positive Emotion Regulation
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Mindfulness
Description
Changes in Mindfulness as measured by the Five Facets of Mindfulness Questionnaire [At baseline, 1-month follow-up, and 6-month follow-up]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Alcohol Trouble
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Hangover Symptoms
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Substance Use Attitudes and Beliefs
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Additional Facets of Aggression
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Mental Health Symptoms
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
Changes in Trauma Symptoms
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up
Title
App Usage
Description
App Usage as assessed by objective app usage data (date/time stamps for each app feature) [Up through 6-month follow-up]
Time Frame
Up through 6-month follow-up
Title
Digital Working Alliance
Description
Digital Working Alliance as measured by the Digital Working Alliance Inventory [At 1-month follow-up]
Time Frame
1-month follow-up
Title
Juvenile Justice Involvement
Description
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]
Time Frame
Baseline, 1-month follow-up, 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley D Kendall, PhD
Phone
(312) 355-1836
Email
akendall@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley D Kendall, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley D Kendall, PhD
Phone
312-355-1836
Email
akendall@uic.edu
First Name & Middle Initial & Last Name & Degree
Ashley D Kendall, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Testing a Meditation App With Justice-Involved Youth on Probation

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