N/A
N=110
Testing the Effect of the Youth Mindful Awareness Program on Negative Affect
Mindfulness
Bottom Line
View on ClinicalTrials.gov: NCT04718129 ↗Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Momentary Negative Affect Assessed With Ecological Momentary Assessment — -.17; .14 score on a scale — p=.048
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Youth Mindful Awareness Program (YMAP) (Behavioral)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Momentary Negative Affect Assessed With Ecological Momentary Assessment |
-.17; .14 | .048 sig |
Summary
Randomized controlled trial comparing a coached, app-based mindfulness intervention versus a no-intervention control condition. Primary outcome: adolescents' reports of affect as measured with ecological momentary assessment (EMA) at post-intervention. Participants will include 120 youth ages 12-17 years old.
Eligibility Criteria
Inclusion Criteria
- ages 12- to 17-years-old
- has access to a smartphone, tablet, or other mobile device on which they can access the mindfulness app and complete EMA reports. Youth without a device will be provided with one for their time in the study.
Exclusion Criteria
- current DSM5 diagnosis of an anxiety or depressive disorder with significant clinical impairment
- current alcohol or substance use disorder; currently suicidal
- lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay
- reading level below 4th grade
- not English speaking at a level that would allow them to participate in the intervention and assessments.
Data sourced from ClinicalTrials.gov (NCT04718129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.