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

Sponsor

Vanderbilt University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04718129

Collaborator

Northwestern University (Other), University of California, Los Angeles (Other)

120

Enrollment

Location

Arms

20.6

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mindfulness	Behavioral: Youth Mindful Awareness Program (YMAP)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Mindfulness vs. No intervention controlMindfulness vs. No intervention control

Masking:

Single (Outcomes Assessor)

Masking Description:

Assessors of outcomes will be masked to intervention condition

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

May 15, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness App-based, coached Mindfulness Program. Nne weekly coached sessions with practice exercises between sessions.	Behavioral: Youth Mindful Awareness Program (YMAP) The Mindfulness Intervention is an app-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.

Arm

Intervention/Treatment

Experimental: Mindfulness

App-based, coached Mindfulness Program. Nne weekly coached sessions with practice exercises between sessions.

Behavioral: Youth Mindful Awareness Program (YMAP)

The Mindfulness Intervention is an app-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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
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
estimated IQ < 75
not English speaking at a level that would allow them to participate in the intervention and assessments.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Judy Garber	Nashville	Tennessee	United States	37203

Sponsors and Collaborators

Vanderbilt University
Northwestern University
University of California, Los Angeles

Investigators

Principal Investigator: Judy Garber, PhD, Vanderbilt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Judith Garber, Principal Investigator, Vanderbilt University

ClinicalTrials.gov Identifier:

NCT04718129

Other Study ID Numbers:

570035

First Posted:

Jan 22, 2021

Last Update Posted:

Aug 12, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Judith Garber, Principal Investigator, Vanderbilt University

Mindfulness

Study Results

No Results Posted as of Aug 12, 2022