Actively Recruiting
Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems (R33)
Led by Vanderbilt University · Updated on 2025-08-20
360
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether an online mindfulness program can reduce and prevent mood and anxiety symptoms in adolescents who are at risk due to high levels of trait negative affect, a tendency to experience frequent and intense negative emotions. This randomized clinical trial compares the mindfulness program to a supportive comparison group and a no-intervention control group. The study focuses on reducing momentary negative emotions and internalizing problems in youth aged 12 to 17 years old. Participants are randomly assigned to one of three groups: the Mindfulness Program, the Supportive Active Comparison, or a Control group. The Mindfulness Program involves nine weekly 30-minute online sessions with a coach teaching mindfulness skills like calm breathing and gratitude. The Supportive Active group also meets weekly online with a coach to discuss personal thoughts and feelings, using active listening and expressive writing. The Control group completes assessments only at the same time points as the other groups. Participants will be assessed before the intervention, after the 9-week program, and again at a six-month follow-up. Assessments include measures of momentary negative affect and internalizing symptoms using ecological momentary assessment and diagnostic evaluations. The study aims to understand how mindfulness training affects emotional regulation and the development of anxiety and depression symptoms in vulnerable youth over time.
CONDITIONS
Brief Title
A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 12 to 17 years
- Parental consent is required
- Participant assent is required
- Must live in Illinois, California, or Tennessee
You will not qualify if you...
- 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 able to speak English well enough to participate in the intervention and assessments
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (remote)
Duration - 9 weeks
Participants engage in weekly remote sessions with a coach for nine weeks. Those in the Mindfulness Program learn mindfulness skills and practice exercises, while those in the Supportive Active Comparison discuss their thoughts and feelings with coaching support. Participants in the control group do not receive an intervention but complete assessments at the same time points.
Weekly remote sessions for nine weeks
Duration - Approximately 6 months
Participants complete follow-up assessments approximately 10 weeks after baseline and again at six months to evaluate momentary negative affect, internalizing symptoms, and diagnoses of anxiety and depressive disorders.
3 assessment visits (remote) at post-intervention and six-month follow-up
Trial Site Locations
Total: 3 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
Northwestern University
Evanston, Illinois, United States, 60208
Actively Recruiting
3
Vanderbilt University
Nashville, Tennessee, United States, 37203-5721
Actively Recruiting
Research Team
J
Judith A Garber, PhD
S
Steven D Hollon, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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