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Recruiting NCT07674303

Multi-Site Feasibility Testing a Meditation App for Youth in the Legal System

No phase Interventional Behavioral Health

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bodhi AIM, HIB.
Who it may be relevant to
Registry conditions: Behavioral Health. Basic parameters: 13 years — 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Improving Psychological Wellbeing and Decreasing Psychological Distress Among Youth in the Legal System: Multi-Site Feasibility Trial of a Mindfulness Meditation App

Overview

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.

Interventions

  • Behavioral Bodhi AIM
    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).
  • Behavioral HIB
    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 measures

  • App adherence (binary) [Time frame: 1 month]
  • App adherence (continuous) [Time frame: 1 month]
Secondary outcome measures (7)
  • Enrollment [Time frame: Baseline]
  • Randomization [Time frame: Baseline]
  • Retention [Time frame: 1 month, 6 months]
  • Health questionnaire completion [Time frame: Baseline, 1 month, 6 months]
  • Acceptability of Intervention Measure (AIM) [Time frame: 1 month]
  • Intervention Appropriateness Measure (IAM) [Time frame: 1 month]
  • Feasibility of Intervention Measure (FIM) [Time frame: 1 month]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Illinois Chicago — Chicago

Identifiers

NCT: NCT07674303 · 2024-0437 · R01AT012892

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗