A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).

Part of paid clinical trials in Los Angeles, California.

Sponsor
Vanderbilt University
Study ID
NCT06526052
Status
Recruiting
Apply to this trial

Conditions

  • Control
  • Prevention

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Mindfulness Program — BEHAVIORAL
    Online, coached mindfulness training program
  • Active Comparator — BEHAVIORAL
    Remote meetings with a supportive coach

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Aug 2025
Primary completion
Mar 31, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

Ecological Momentary Assessment of Momentary Negative Affect and Stress [ Time Frame: week 10 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Michelle G Craske, PhD
[email protected]
310-825-8403
Denise A Chavira, PhD
[email protected]
310-825-8466
Northwestern UniversityEvanstonIllinois60208
Richard E Zinbarg, PhD
[email protected]
847-467-2290
Emma K Adam, PhD
[email protected]
847-467-2010
Vanderbilt UniversityNashvilleTennessee37203-5721
Judith A Garber, PhD
[email protected]
615-330-5605
Steven D Hollon, PhD
[email protected]
6153305604
Judith A Garber, PhD (PRINCIPAL_INVESTIGATOR)
Steven D Hollon, PhD (SUB_INVESTIGATOR)

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University of California, Los Angeles· Los Angeles, CANorthwestern University· Evanston, ILVanderbilt University· Nashville, TN

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