Improving Psychological Wellbeing and Decreasing Psychological Distress Among Youth in the Legal System: Multi-Site Feasibility Trial of a Mindfulness Meditation App
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- App adherence (binary)
Study Overview
Brief Summary
This multi-site feasibility clinical trial aims to assess the feasibility of implementing a 1-month app-based meditation program with youth in 4 heterogeneous juvenile legal systems across Oregon and New York. The primary question it is designed to answer is: Will youth adequately adhere to the 1-month meditation app across sites? Secondary feasibility outcomes pertain to recruitment, randomization, retention, and survey completion.
Detailed Description
The investigators aim to enroll 120 youth (30/site) 13-20 years old who report regular access to an Apple or Android smartphone. Following completion of a baseline survey, 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 meditation app 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. All study activities will be remote.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Masking Description
Both participants and outcome assessors will be blind to condition through completion of the baseline assessments. Condition will become apparent to both participants and assessors at the time of app download, but will not be revealed to assessors at any of the follow-up time points until after the quantitative measures are complete.
Eligibility Criteria
- Ages
- 13 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •13-20 years old
- •In probation or related programming (i.e., in legal programming but not detained) in Oregon or New York State
- •Have access to an Apple/Android smartphone
- •Understand and provide assent/consent
- •Have legal guardian permission (if under 18 years old)
- •English-speaking, due to norming of instruments
Exclusion Criteria
- •- There are no exclusion criteria.
Arms & Interventions
Bodhi AIM
Participants randomized to the intervention arm will receive the Bodhi AIM meditation app.
Intervention: Bodhi AIM (Behavioral)
HIB
Participants randomized to the active control arm will receive the HIB health promotion app.
Intervention: HIB (Behavioral)
Outcomes
Primary Outcomes
App adherence (binary)
Time Frame: 1 month
Percentage of participants who play at least one file on their study app after baseline.
App adherence (continuous)
Time Frame: 1 month
Average number of daily app files played over the 1-month intervention period.
Secondary Outcomes
- Enrollment(Baseline)
- Randomization(Baseline)
- Retention(1 month, 6 months)
- Health questionnaire completion(Baseline, 1 month, 6 months)
- Acceptability of Intervention Measure (AIM)(1 month)
- Intervention Appropriateness Measure (IAM)(1 month)
- Feasibility of Intervention Measure (FIM)(1 month)
Investigators
Ashley D Kendall
Principal Investigator
University of Illinois at Chicago