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

Mindfulness Clinical Trial

— YMAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04718129
• Other study ID #: 570035
• Status: Completed
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: July 5, 2023

Study information

• Verified date: November 2023
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 5, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mindfulness

Intervention

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.

Locations

Country	Name	City	State
United States	Judy Garber	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	Northwestern University, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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