Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP)

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

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.

Study Overview

• Status: Completed
• Conditions: Mindfulness
• Intervention / Treatment: Behavioral: Youth Mindful Awareness Program (YMAP)

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Judy Garber, PhD; Phone Number: 1-615-343-8714; Email: judy.garber@vanderbilt.edu
• Study Contact Backup: Name: Jennifer Fuller, M.A.; Phone Number: 1-615-343-8714; Email: jennifer.fuller@vanderbilt.edu

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Judy Garber

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions.	Behavioral: Youth Mindful Awareness Program (YMAP); The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions.
No Intervention: Control; Participants in this arm are randomly assigned to an assessment-only, no intervention control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Negative Affect assessed with Ecological Momentary Assessment	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.	Through study completion, an average of 12 weeks

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: University of California, Los Angeles; Northwestern University
• Investigators: Principal Investigator: Judy Garber, PhD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: November 29, 2020
• First Submitted That Met QC Criteria: January 15, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness
• Other Study ID Numbers: 570035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Results will be shared through Clinical Trials.gov, and by the study PIs at scientific conferences and publications in scientific journals. IPD will be available upon request.
• IPD Sharing Time Frame: Data will be available after study completion and publications of study results.
• IPD Sharing Access Criteria: Access to study data will require a written request to the PIs. The request should include a description of the research question(s), planned analyses, and data requested.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No