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

ConditionBehavioral Health

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age13-20

SponsorUniversity of Illinois at Chicago

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Bodhi AIMExperimental treatment 1 intervention

Group B: HIBActive comparator 1 intervention

Trial outcomes

Primary outcomes

App adherence (binary)

Percentage of participants who play at least one file on their study app after baseline.

Time frame

1 month

App adherence (continuous)

Average number of daily app files played over the 1-month intervention period.

Time frame

1 month

Secondary outcomes

Enrollment

Number of participants enrolled

Time frame

Baseline

Randomization

Percentage of participants randomized to each arm who play at least one app file

Time frame

Baseline

Retention

Percentage of participants who attend (yes/no) each follow-up visit

Time frame

1 month, 6 months

Health questionnaire completion

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

Time frame

Baseline, 1 month, 6 months

Other outcomes

Ecological momentary assessment (EMA) completion

Percentage of EMA reports made out of total EMA prompts sent at each EMA burst

Time frame

Baseline, 1 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Illinois at Chicago

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov

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