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

NCT06526052 | Recruiting DMC

• 2 other identifiers: R33MH1192704R33MH119270-03
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

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

Keywords

Adolescents; Mindfulness; Internalizing

Outcome Measures

Primary Outcomes (2)

• Ecological Momentary Assessment of Momentary Negative Affect and Stress

  EMA involves assessments four times a day for 7 days. The measures of momentray negative affect (mNA) from the EMA are Stressor-Independent (mNA-SI), Stressor-Reactive (mNA-SR), and average mNA.

  week 10

• Internalizing symptoms factor

  The internalizing symptoms factor is based on a principal components analyses (PCAs) of the change scores for child symptom scales including the Negative Affectivity (NA-15), the Patient Health Question 9 (PHQ9 - measure of depressive symptoms), Generalized Anxiety Disorder 7 (GAD7 - measure of symptoms of anxiety), and the Screen for Child Anxiety Related Disorders (SCARED).

  week 12

Secondary Outcomes (3)

• Internalizing symptoms factor

  Six-months

• Diagnoses of Anxiety and Depressive Disorders

  week 12

• Diagnoses of Anxiety and Depressive Disorders

  Six-months

Study Arms (3)

Mindfulness Program

EXPERIMENTAL

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).

Behavioral: Mindfulness Program

Supportive Active Comparison

ACTIVE COMPARATOR

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.

Behavioral: Active Comparator

Control

NO INTERVENTION

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 BEHAVIORAL

Online, coached mindfulness training program

Mindfulness Program

Active Comparator BEHAVIORAL

Remote meetings with a supportive coach

Also known as: Supportive Active Comparison

Supportive Active Comparison

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (3)

University of California, Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Northwestern University

Evanston, Illinois, 60208, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37203-5721, United States

RECRUITING

Study Officials

• Megan M Saylor, PhD

  Vanderbilt University

  STUDY CHAIR

Central Study Contacts

Judith A Garber, PhD

CONTACT

6153305605; jgarber.vanderbilt@gmail.com

Steven D Hollon, PhD

CONTACT

6153305604; steven.d.hollon@vanderbilt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators will be unaware (masked) of the condition to which participants are randomized.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to one of three conditions in parallel for the duration of the study

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)