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Clinical Trials/NCT04718129
NCT04718129
Completed
Not Applicable

Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems - R61

Vanderbilt University1 site in 1 country110 target enrollmentMay 15, 2021
ConditionsMindfulness

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mindfulness
Sponsor
Vanderbilt University
Enrollment
110
Locations
1
Primary Endpoint
Momentary Negative Affect Assessed With Ecological Momentary Assessment
Status
Completed
Last Updated
last year

Overview

Brief 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.

Detailed Description

This is a randomized controlled trial testing a 9-session, coached, app-based mindfulness intervention on adolescents' reports of affect as measured with ecological momentary assessment (EMA). Participants will include 120 youth ages 12- to 17-years-old randomized to either the Youth Mindful Awareness Program (YMAP) or to an assessment only control condition. Participation is open to all genders and youth of all races and ethnicities.

Registry
clinicaltrials.gov
Start Date
May 15, 2021
End Date
July 5, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Judith Garber

Principal Investigator

Vanderbilt University

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.

Outcomes

Primary Outcomes

Momentary Negative Affect Assessed With Ecological Momentary Assessment

Time Frame: 5 days

Momentary negative affect (mNA) in EMA is the experience of negative emotional states in the moment. Participants complete the Ecological Momentary Assessment (EMA) 4 times a day for 5 days, at random moments across the day (usually once in the morning, once in the early afternoon, once in the late afternoon and once in the evening). The EMA affect measure includes 7 items rated on a 4-point scale; average scores range from 1.00 to 4.00; higher scores indicate more negative affect (NA).

Study Sites (1)

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