Teenage Health and Wellness Study (THAW)

The Pennsylvania State University (PENNSTATE)

Status: Completed

Conditions: Depression Symptoms; Externalizing Symptoms; Anxiety; Stress

Treatments: Behavioral: The Mind in Action; Behavioral: Healthy Topics

Study type: Interventional

Funder types: Other

Identifiers

NCT03989934

R61AT009856

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 13 to 16 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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203 participants in 2 patient groups

The Mind in Action

Experimental group

Description:

The Mind in Action is a mindfulness intervention developed by the Holistic Life Foundation (HLF), a Baltimore-based non-profit organization. The curriculum will be delivered over approximately 40 sessions and will follow HLF's typical program modifications for high school students (i.e., sustained focus on breath work and meditation). Each program session will include an initial exercise of focusing on the breath to center oneself, followed by the introduction and practice of different breathing techniques (e.g., rhythmic breathing) that enhance calmness and reduce physiological arousal, and concluding with a brief guided meditation. Instructors will describe benefits of the practices for health and stress management. Participants are given assignments between sessions to reinforce lessons (e.g., breathing exercises or periods of meditation).

Treatment:

Behavioral: The Mind in Action

Healthy Topics

Active Comparator group

Description:

Adapted from the Glencoe Health Curriculum (McGraw Hill), Healthy Topics is designed to control for the effects of a positive adult, time and attention, a small group learning environment, engaged instruction, and interesting material. The Healthy Topics curriculum has been successfully implemented as an effective active control condition, with student engagement and participation comparable to the intervention arm. The curriculum includes information about nutrition, exercise, sleep, drug use, and other topics related to physical health.

Treatment:

Behavioral: Healthy Topics