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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Recruiting
CT.gov ID
NCT05146167
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
200
1
2
31.9
6.3

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Bodhi AIM (intervention group)
  • Behavioral: HIB (control group)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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.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 (Outcomes Assessor)
Masking Description:
Outcomes assessors will be masked to arm through completion of outcome assessments.
Primary Purpose:
Prevention
Official Title:
Reducing HIV/Sexually Transmitted Infection (STI) Risk Behaviors Among Juvenile Offenders on Probation: A Mobile Mindfulness-Based Intervention
Actual Study Start Date :
Apr 5, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Changes in Negative Emotion Regulation [Baseline, 1-month follow-up, 6-month follow-up]

    Changes in Negative Emotion Regulation as measured by the Negative Mood Regulation Scale [At baseline, 1-month follow-up, and 6-month follow-up]

  2. Changes in Alcohol Use [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  3. Changes in Cannabis Use [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  4. Changes in Sexual Behavior [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  5. Changes in Aggression [Baseline, 1-month follow-up, 6-month follow-up]

    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

  1. Changes in Positive Emotion Regulation [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  2. Changes in Mindfulness [Baseline, 1-month follow-up, 6-month follow-up]

    Changes in Mindfulness as measured by the Five Facets of Mindfulness Questionnaire [At baseline, 1-month follow-up, and 6-month follow-up]

  3. Changes in Alcohol Trouble [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  4. Changes in Hangover Symptoms [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  5. Changes in Substance Use Attitudes and Beliefs [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  6. Changes in Additional Facets of Aggression [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  7. Changes in Mental Health Symptoms [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  8. Changes in Trauma Symptoms [Baseline, 1-month follow-up, 6-month follow-up]

    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]

  9. App Usage [Up through 6-month follow-up]

    App Usage as assessed by objective app usage data (date/time stamps for each app feature) [Up through 6-month follow-up]

  10. Digital Working Alliance [1-month follow-up]

    Digital Working Alliance as measured by the Digital Working Alliance Inventory [At 1-month follow-up]

  11. Juvenile Justice Involvement [Baseline, 1-month follow-up, 6-month follow-up]

    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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois at Chicago Chicago Illinois United States 60612

Sponsors and Collaborators

  • University of Illinois at Chicago
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Ashley D Kendall, PhD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ashley D Kendall, Assistant Professor, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT05146167
Other Study ID Numbers:
  • 2018-0889
  • R00DA047890
First Posted:
Dec 6, 2021
Last Update Posted:
Apr 7, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ashley D Kendall, Assistant Professor, University of Illinois at Chicago
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 7, 2022