Purpose

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

Eligibility

Eligible Ages
Between 12 Years and 17 Years
Eligible Genders
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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Mindfulness vs. No intervention control
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)
Masking Description
Assessors of outcomes will be masked to intervention condition

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Mindfulness
App-based, coached Mindfulness Program. Eight 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 8 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.

Recruiting Locations

Judy Garber
Nashville, Tennessee 37203
Contact:
Judy Garber, PhD
615-343-8714
jgarber.vanderbilt@gmail.com

More Details

Status
Recruiting
Sponsor
Vanderbilt University

Study Contact

Judy Garber, PhD
1-615-343-8714
judy.garber@vanderbilt.edu

Detailed Description

This is a randomized controlled trial testing an 8-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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.