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Completed

NCT Number: NCT04718129

Testing the Effect of the Youth Mindful Awareness Program on Negative Affect

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.

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Key information

Conditions

Mindfulness

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Judy Garber

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Youth Mindful Awareness Program (YMAP)

Behavioral

The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions.

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Northwestern University
  • University of California, Los Angeles

Registry information

Official study title

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

Acronym: YMAP

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 22, 2021
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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