Recruiting

Youth Mindful Awareness

Sponsor:

Vanderbilt University

Code:

NCT06526052

Conditions

Prevention

Control

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

Mindfulness Program

Active Comparator

Study Details

Brief summary:

The goal of this randomized clinical trial is to compare the effects of an online mindfulness program to an active supportive comparison condition and a no-intervention control group on reducing and preventing mood and anxiety symptoms in at-risk youth. Youth who are high on trait negative affect will be randomized to one of the three conditions. The primary outcomes of interest are reductions in momentary negative affect and internalizing problems in adolescents ages 12 to 17 years old. All participants will be evaluated prior to being randomized, after the 9-session intervention period, and at a 6-month follow-up.

The first hypothesis is that the mindfulness intervention will predict decreases in stressor-reactive momentary negative affect and internalizing symptoms. The second hypothesis is that changes in momentary negative affect will partially account for the effects of the mindfulness intervention on internalizing symptoms.

Conditions

Prevention

Control

Study ID

NCT06526052

Start date

Apr 1, 2024

Status verified date

Aug, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Ages 12, 13, 14, 15, 16, 17
  • Parental Consent
  • Participant Assent
  • Live in Illinois, California, or Tennessee

Exclusion Criteria:

  • current diagnosis of an anxiety or depressive disorder with significant clinical impairment
  • current alcohol or substance use disorder
  • current serious suicidal ideation or behavior
  • 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 Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mindfulness Program

The Mindfulness Program is an online, coached intervention that teaches mindfulness activities such as calm breathing, listening, acceptance, gratitude, and compassion. Participants meet with their coach weekly for nine 30-minute, weekly sessions in which they learn mindfulness skills and practice using the mindfulness exercises between sessions. Meetings are done remotely (e.g., Zoom).

active comparator: Supportive Active Comparison

The Supportive Active condition involves participants meeting remotely (e.g., Zoom) with a coach for nine 30-minute, weekly sessions during which teens discuss their thoughts and feelings about things going on in their life. Coaches are instructed to use active listening, open-ended questions, empathy, reflection, and unconditional positive regard. Between sessions, teens use expressive writing to describe and understand their thoughts and feelings about situations in their life.

no intervention: Control

This is an assessment only control condition. Participants complete all of the same measures as do youth in the other two conditions at the same time points (i.e., baseline, post-intervention (about 10 weeks after baseline) and at a six-month follow-up.

Interventions

Mindfulness Program

Online, coached mindfulness training program

Active Comparator

Remote meetings with a supportive coach

Primary outcome measure

  • Ecological Momentary Assessment of Momentary Negative Affect and Stress [ Time Frame: week 10 ]
  • Internalizing symptoms factor [ Time Frame: week 12 ]

Central Contacts and Locations

Central contacts

Judith A Garber, PhD

6153305605jgarber.vanderbilt@gmail.com

Steven D Hollon, PhD

6153305604steven.d.hollon@vanderbilt.edu

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Michelle G Craske, PhD

310-825-8403MCraske@mednet.ucla.edu

Denise A Chavira, PhD

310-825-8466dchavira@psych.ucla.edu

Northwestern University

Recruiting

Evanston, Illinois, United States, 60208

Contacts

Richard E Zinbarg, PhD

847-467-2290rzinbarg@northwestern.edu

Emma K Adam, PhD

847-467-2010ek-adam@northwestern.edu

Vanderbilt University

Recruiting

Nashville, Tennessee, United States, 37203-5721

Contacts

Judith A Garber, PhD

615-330-5605jgarber.vanderbilt@gmail.com

Steven D Hollon, PhD

6153305604steven.d.hollon@vanderbilt.edu

Principal Investigator:

Judith A Garber, PhD

More Information

Sponsor

Vanderbilt University

Last update posted

Aug 20, 2025

Last verified

Aug, 2025

Keywords

  • Adolescents
  • Mindfulness
  • Internalizing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Vanderbilt University on 2025-08-20.