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

Not Applicable

Completed

• Conditions: Mindfulness
• Interventions: Behavioral: Youth Mindful Awareness Program (YMAP)

• Registration Number: NCT04718129
• Lead Sponsor: Vanderbilt University

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.

Study Timeline

• Study First Submitted: 2020-11-29
• Study First Submitted QC: 2021-01-15
• Study First Posted: 2021-01-22
• Study Start: 2021-05-15
• Primary Completion: 2023-06-30
• Study Completion: 2023-07-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness	Youth Mindful Awareness Program (YMAP)	Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions.

Primary Outcome Measures

Name	Time	Method
Negative Affect assessed with Ecological Momentary Assessment	Through study completion, an average of 12 weeks	The measure of momentary negative affect includes 7 items rated on a 4-point scale; average scores can range from 1.00 to 4.00. Higher scores indicate more negative affect.

Trial Locations

Locations (1)

Judy Garber; 🇺🇸 Nashville, Tennessee, United States