Behavioral Health
Conditions
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.
Interventions
BEHAVIORALBodhi 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).
BEHAVIORALHIB
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.
Sponsors
University of Illinois at Chicago
National Center for Complementary and Integrative Health (NCCIH)
Study design
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.
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 meditation app, or (2) HIB (Health In Balance), a health promotion control app matched to Bodhi AIM for time and structure.
Eligibility
Sex/Gender
ALL
Age
13 Years to 20 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTAshley D Kendall, PhD
Outcome results
None listed