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

NCT07674303 — Not applicable, Recruiting, 120 participants, University of Illinois at Chicago

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

RegistryNCT07674303
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, prevention
Enrollment120 (Estimated)
SponsorUniversity of Illinois at Chicago (Other); collaborators: National Center for Complementary and Integrative Health (NCCIH)
ConditionsBehavioral Health
InterventionsBodhi AIM, HIB (Behavioral)
Datesstart 2026-07-30, primary completion 2028-06-01 (estimated), completion 2028-06-01 (estimated), first posted 2026-06-29, last updated 2026-08-07
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Behavioral Health All trials of Bodhi AIM All trials of HIB

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Bodhi AIMExperimentalBehavioral: Bodhi AIMParticipants randomized to the intervention arm will receive the Bodhi AIM meditation app.
HIBActive comparatorBehavioral: HIBParticipants randomized to the active control arm will receive the HIB health promotion app.
  • Bodhi AIM (Behavioral): 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).
  • HIB (Behavioral): 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 outcomes

  • App adherence (binary) [1 month]: Percentage of participants who play at least one file on their study app after baseline.
  • App adherence (continuous) [1 month]: Average number of daily app files played over the 1-month intervention period.

Secondary outcomes

  • Enrollment [Baseline]: Number of participants enrolled
  • Randomization [Baseline]: Percentage of participants randomized to each arm who play at least one app file
  • Retention [1 month, 6 months]: Percentage of participants who attend (yes/no) each follow-up visit
  • Health questionnaire completion [Baseline, 1 month, 6 months]: Percentage of participants who complete the questionnaire measures of psychological wellbeing (PROMIS Pediatric Bank v1.0 Positive Affect, NIH Toolbox Pediatric Item Bank v3.0 Self-Efficacy CAT) and psychological distress (PROMIS Pediatric Item Bank GenPop v3.0 Anxiety, PROMIS Pediatric Item Bank GenPop v3.0 Depressive Symptoms, PROMIS Pediatric Bank v 1.0 Psychological Stress Experiences) at each time point
  • Acceptability of Intervention Measure (AIM) [1 month]: Four-item scale assessing perceived acceptability of the intervention. Items are rated on a 5-point Likert scale and averaged to produce a total score ranging from 1 to 5; with higher scores indicating greater acceptability.
  • Intervention Appropriateness Measure (IAM) [1 month]: Four-item scale assessing perceived appropriateness of the intervention. Items are rated on a 5-point Likert scale and averaged to produce a total score ranging from 1 to 5; with higher scores indicating greater appropriateness.
  • Feasibility of Intervention Measure (FIM) [1 month]: Four-item scale assessing perceived feasibility of the intervention. Items are rated on a 5-point Likert scale and averaged to produce a total score ranging from 1 to 5; with higher scores indicating greater feasibility.

Other outcomes

  • Ecological momentary assessment (EMA) completion [Baseline, 1 month]: Percentage of EMA reports made out of total EMA prompts sent at each EMA burst

+Eligibility

Sex: All, ages: 13 Years to 20 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
University of Illinois ChicagoChicago, IllinoisUnited StatesRecruiting

+Funding

NIH grants: R01AT012892