Clinical trial NCT03989934: Teenage Health and Wellness Study
Official title: Optimizing a Mindful Intervention for Urban Minority Youth Via Stress Physiology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Externalizing Symptoms
Depression Symptoms
Anxiety
Keywords: mindfulness; stress physiology; urban youth
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins Bloomberg School of Public Health
name: University of Cincinnati
name: University of North Carolina, Chapel Hill
First posted: 2019-06-18
Enrollment: 203
Sex: ALL
Minimum age (years): 13
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study evaluates the effects of mindfulness on physiological stress mechanisms implicated in externalizing behaviors and symptoms of affective and traumatic stress among urban adolescents. Program effects on stress physiology will be evaluated using pre- and post-tests of heart rate variability (HRV) during a stress task. Emotional and behavioral outcomes will be measured using student and teacher ratings.

Detailed description: Low-income urban adolescents experience high rates of adversity and trauma exposure, increasing their risk for stress-related problems, including externalizing behaviors and affective and traumatic stress symptoms. These outcomes are associated with dysregulated physiological responses to stress, both in the laboratory and real-world contexts. The neuroplasticity that typifies adolescence heightens vulnerability to stress effects on various brain and body systems. On the other hand, the same neurodevelopmental features also suggest pathways for overcoming and altering stymied trajectories through targeted interventions that leverage the brain's plasticity. Thus, adolescence affords a window of opportunity to reinforce parasympathetic modulation of stress responses, enhancing capacities for emotion regulation and, in effect, protecting against the development of behavioral and affective problems.

There is growing empirical support for the ability of mindfulness-based programs to improve stress management in adults, leading to improved well-being, coping and prosocial behavior. Evidence suggests that mindfulness influences homeostatic systems that modulate neurophysiological responses to stress in the service of emotion regulation. Indeed, neuroimaging studies in adults have established that mindfulness measurably improves brain function, demonstrating the alterability of these mechanisms. No such data have been collected for youth, nor have the psychophysiological mechanisms underlying mindfulness program effects for disadvantaged urban youth been rigorously evaluated. The proposed research thus has potential to substantively advance understanding of mindfulness mechanisms of effects and also to facilitate optimization of mindfulness programming so that it has maximum benefits for urban youth.

This study evaluates the effects of mindfulness on physiological stress mechanisms implicated in externalizing behaviors and symptoms of affective and traumatic stress among urban adolescents. Program effects on stress physiology will be evaluated using pre- and post-tests of heart rate variability (HRV) during a stress task. Emotional and behavioral outcomes will be measured using student and teacher ratings.

Eligibility criteria: Inclusion Criteria:

* Must be in the 9th grade at one of the Baltimore City Public Schools participating in the study
* Must provide parental permission and assent.

Exclusion Criteria:

* Students in foster care
* Students in self-contained special education classrooms

Primary outcomes:
measure: Heart rate variability (HRV)
timeFrame: 25 minutes
Secondary outcomes:
measure: Child Behavior Checklist:
timeFrame: 10 minutes
measure: Strengths and Difficulties Questionnaire
timeFrame: 8 minutes
measure: Patient-Reported Outcomes Measurement Information System
timeFrame: 6 minutes
measure: Child PTSD Symptom Scale
timeFrame: 3 minutes
measure: Emotion Regulation Questionnaire
timeFrame: 3 minutes
measure: Background Questionnaire
timeFrame: 3 minutes
measure: Youth Risk Behavior Survey
timeFrame: 10 minutes
measure: Brief COPE
timeFrame: 5 minutes
measure: Perceived Stress Scale
timeFrame: 3 minutes
measure: Child and Adolescent Mindfulness Measure
timeFrame: 3 minutes
measure: Adverse Childhood Experiences Checklist
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore City Public Schools
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Tamar Mendelson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State University
name: Diana Fishbein, PhD
role: PRINCIPAL_INVESTIGATOR
References: