NCT06526052 A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).
| NCT ID | NCT06526052 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Vanderbilt University |
| Condition | Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2024-04-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Megan M Saylor, PhD
STUDY CHAIR
Vanderbilt University
Frequently Asked Questions
Who can join the NCT06526052 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06526052 currently recruiting?
Yes, NCT06526052 is actively recruiting participants. Contact the research team at jgarber.vanderbilt@gmail.com for enrollment information.
Where is the NCT06526052 trial being conducted?
This trial is being conducted at Los Angeles, United States, Evanston, United States, Nashville, United States.
Who is sponsoring the NCT06526052 clinical trial?
NCT06526052 is sponsored by Vanderbilt University. The principal investigator is Megan M Saylor, PhD at Vanderbilt University. The trial plans to enroll 360 participants.