Clinical trial NCT05146167: Feasibility Testing a Meditation App With Justice-Involved Youth on Probation
Official title: Reducing HIV/Sexually Transmitted Infection (STI) Risk Behaviors Among Juvenile Offenders on Probation: A Mobile Mindfulness-Based Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotion Regulation
Alcohol Use
Cannabis Use
Sexual Behavior
Aggression
Keywords: HIV prevention
Juvenile justice
Mindfulness
mHealth
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-12-06
Enrollment: 107
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in Negative Emotion Regulation
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Alcohol Use
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Cannabis Use
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Sexual Behavior
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Aggression
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Changes in Positive Emotion Regulation
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Mindfulness
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Alcohol Trouble
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Hangover Symptoms
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Substance Use Attitudes and Beliefs
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Additional Facets of Aggression
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Mental Health Symptoms
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: Changes in Trauma Symptoms
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
measure: App Usage
timeFrame: Up through 6-month follow-up
measure: Digital Working Alliance
timeFrame: 1-month follow-up
measure: Juvenile Justice Involvement
timeFrame: Baseline, 1-month follow-up, 6-month follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Ashley D Kendall, PhD
role: PRINCIPAL_INVESTIGATOR
References: