About this trial

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

This trial accepts healthy volunteers

Qualifiers

Ages 12, 13, 14, 15, 16, 17

Parental Consent

Participant Assent

Live in Illinois, California, or Tennessee

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

360 Participants

are divided into 3 treatment groups

Group A: Mindfulness ProgramExperimental treatment 1 intervention

Group B: Supportive Active ComparisonActive comparator 1 intervention

Group C: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame

week 10

2

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).

Time frame

week 12

Secondary outcomes

1

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).

Time frame

Six-months

2

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).

Time frame

week 12

3

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.

Time frame

Six-months

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts