Clinical trial NCT06526052: A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).
Official title: Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems (R33)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prevention
Control
Keywords: Adolescents
Mindfulness
Internalizing
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-07-29
Enrollment: 360
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of three conditions in parallel for the duration of the study
Primary purpose: PREVENTION

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.

Detailed description: Rates of anxiety and depression in youth are substantial, causing a major unmet need for effective prevention and treatment. A salient risk factor for anxiety and depression is negative affectivity - a partially heritable propensity to experience and express more frequent, intense, and enduring aversive emotional states. Prior longitudinal studies have shown that elevated trait negative affectivity (tNA) during mid-adolescence predicted internalizing disorders later in adolescence and early adulthood, and this relation was partially mediated by changes in momentary negative affect (mNA) measured with ecological momentary assessment (EMA). The conceptual rationale for this investigation is as follows: Trait negative affectivity (tNA) is a risk factor for internalizing symptoms and disorders. tNA also predicts higher levels of momentary negative affect (mNA), measured with EMA, which in turn partially accounts for the prospective association between tNA and symptoms of anxiety and depression. Mindfulness interventions reduce both mNA and internalizing symptoms. Given these empirical relations, this study will test whether in youth with high levels of tNA, an online, coached mindfulness program reduces mNA, as measured with EMA, and whether significantly reducing mNA via a mindfulness intervention then prevents the worsening or onset of internalizing problems.

Mindfulness-based interventions have been found to reduce negative affect and internalizing symptoms in children and adolescents. This study will evaluate changes in mNA as a transdiagnostic target of mindfulness-based training in youth at high risk (i.e., high tNA) for internalizing problems, and the degree to which reductions in such mNA partially account for the effects of mindfulness training on internalizing outcomes in youth. This randomized controlled prevention trial will test the extent to which youth assigned to an online, coached mindfulness program as compared to youth in a supportive attention comparison intervention and a no-intervention control condition will show reduced mNA and its two components -- stressor-independent and stressor-reactive momentary negative affect. The mindfulness training will be implemented through mobile technology (e.g., online program). Investigating the efficacy of an online mode of delivery of mindfulness with support of a coach can advance the prevention of internalizing psychopathology in a manner that could be disseminated broadly. Such technology would improve access to care for youth who can be easily identified as being vulnerable to internalizing problems due to having high levels of tNA.

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

Primary outcomes:
measure: Ecological Momentary Assessment of Momentary Negative Affect and Stress
timeFrame: week 10
measure: Internalizing symptoms factor
timeFrame: week 12
Secondary outcomes:
measure: Internalizing symptoms factor
timeFrame: Six-months
measure: Diagnoses of Anxiety and Depressive Disorders
timeFrame: week 12
measure: Diagnoses of Anxiety and Depressive Disorders
timeFrame: Six-months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Megan M Saylor, PhD
role: STUDY_CHAIR
References: