A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).
NCT Number: NCT06526052
Acronym: YMAP2
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Prevention|Control
Interventions: BEHAVIORAL: Mindfulness Program|BEHAVIORAL: Active Comparator
Sponsor: Vanderbilt University
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: CHILD
Enrollment: 360
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-04-01
Completion Date: 2027-04
Locations: University of California, Los Angeles, Los Angeles, California, 90095, United States|Northwestern University, Evanston, Illinois, 60208, United States|Vanderbilt University, Nashville, Tennessee, 37203-5721, United States

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.

Primary Outcome Measures: 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 Outcome Measures: 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)., Six-months|Diagnoses of Anxiety and Depressive Disorders, The Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version assesses diagnoses at and since baseline and screens for exclusion criteria at baseline (Kaufman et al., 1997)., week 12|Diagnoses of Anxiety and Depressive Disorders, The Schedule for Affective Disorders and Schizophrenia for School-Age Children - Present and Lifetime Version (KSADs-PL) assesses diagnoses of anxiety and depressive disorders since the post-intervention assessment., Six-months