Multi-Site Feasibility Testing a Meditation App for Youth in the Legal System
4. august 2026 opdateret af: Ashley D Kendall, University of Illinois at Chicago
Improving Psychological Wellbeing and Decreasing Psychological Distress Among Youth in the Legal System: Multi-Site Feasibility Trial of a Mindfulness Meditation App
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ashley D Kendall, PhD
- Telefonnummer: 312-355-1836
- E-mail: akendall@uic.edu
Studiesteder
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60612
- Rekruttering
- University of Illinois Chicago
-
Kontakt:
- Ashley D Kendall, PhD
- Telefonnummer: 312-355-1836
- E-mail: akendall@uic.edu
-
Ledende efterforsker:
- Ashley D Kendall, PhD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Bodhi mål
Deltagerne, der er randomiseret til interventionsarmen, vil modtage Bodhi AIM -meditationsappen.
|
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).
|
|
Aktiv komparator: Hib
Deltagerne, der er randomiseret til den aktive kontrolarm, vil modtage HIB Health Promotion -appen.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
App adherence (binary)
Tidsramme: 1 month
|
Percentage of participants who play at least one file on their study app after baseline.
|
1 month
|
|
App adherence (continuous)
Tidsramme: 1 month
|
Average number of daily app files played over the 1-month intervention period.
|
1 month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Enrollment
Tidsramme: Baseline
|
Number of participants enrolled
|
Baseline
|
|
Randomization
Tidsramme: Baseline
|
Percentage of participants randomized to each arm who play at least one app file
|
Baseline
|
|
Retention
Tidsramme: 1 month, 6 months
|
Percentage of participants who attend (yes/no) each follow-up visit
|
1 month, 6 months
|
|
Health questionnaire completion
Tidsramme: 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
|
Baseline, 1 month, 6 months
|
|
Acceptability of Intervention Measure (AIM)
Tidsramme: 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.
|
1 month
|
|
Intervention Appropriateness Measure (IAM)
Tidsramme: 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.
|
1 month
|
|
Feasibility of Intervention Measure (FIM)
Tidsramme: 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.
|
1 month
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ecological momentary assessment (EMA) completion
Tidsramme: Baseline, 1 month
|
Percentage of EMA reports made out of total EMA prompts sent at each EMA burst
|
Baseline, 1 month
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
30. juli 2026
Primær færdiggørelse (Anslået)
1. juni 2028
Studieafslutning (Anslået)
1. juni 2028
Datoer for studieregistrering
Først indsendt
3. juni 2026
Først indsendt, der opfyldte QC-kriterier
23. juni 2026
Først opslået (Faktiske)
29. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. august 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2024-0437
- R01AT012892 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified data may be placed in one or more electronic databases which could be used for other research studies.
IPD-delingstidsramme
Data sharing will generally coincide with publication of the study's main findings and is intended to take place within 1 year after acceptance of the primary manuscripts.
IPD-delingsadgangskriterier
To be determined
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
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