NCT04718129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

May 15, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 1, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

November 29, 2020

Results QC Date

July 28, 2024

Last Update Submit

March 31, 2025

Conditions

Mindfulness

Keywords

Mindfulness

Outcome Measures

Primary Outcomes (1)

  • Momentary Negative Affect Assessed With Ecological Momentary Assessment

    Momentary negative affect (mNA) in EMA is the experience of negative emotional states in the moment. Participants complete the Ecological Momentary Assessment (EMA) 4 times a day for 5 days, at random moments across the day (usually once in the morning, once in the early afternoon, once in the late afternoon and once in the evening). The EMA affect measure includes 7 items rated on a 4-point scale; average scores range from 1.00 to 4.00; higher scores indicate more negative affect (NA).

    5 days

Study Arms (2)

Mindfulness

EXPERIMENTAL

Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions.

Behavioral: Youth Mindful Awareness Program (YMAP)

Control

NO INTERVENTION

Participants in this arm are randomly assigned to an assessment-only, no intervention control condition.

Interventions

Youth Mindful Awareness Program (YMAP)BEHAVIORAL

The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions.

Mindfulness

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Judy Garber

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • Garber J, Chavira DA, Adam EK, Craske MG, McMahon T, Williams A, Abitante G, Lanser I, Pashtunyar DS, Chen S, Zinbarg R. A randomized controlled trial of an online mindfulness program for adolescents at risk for internalizing problems. J Consult Clin Psychol. 2025 Apr;93(4):226-237. doi: 10.1037/ccp0000921. Epub 2024 Dec 2.

    PMID: 39621373DERIVED

Results Point of Contact

Title
Principal Investigator
Organization
Vanderbilt University
jgarber.vanderbilt@gmail.com
615-330-5605

Study Officials

  • Judy Garber, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors of outcomes will be masked to intervention condition
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Mindfulness vs. No intervention control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2020

First Posted

January 22, 2021

Study Start

May 15, 2021

Primary Completion

June 30, 2023

Study Completion

July 5, 2023

Last Updated

April 1, 2025

Results First Posted

April 1, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Data will be available after study completion and publications of study results.
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.

Locations

US(1)