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Completed

NCT Number: NCT03989934

Teenage Health and Wellness Study

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.

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Key information

Age range

13 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore City Public Schools

Baltimore, Maryland, 21202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The Mind in Action

Behavioral

Mindfulness program for adolescents

Healthy Topics

Behavioral

Health education program for adolescents

Primary outcomes

  1. Heart rate variability (HRV)

    Time frame: 25 minutes

    HRV is a biomarker of neural regulation of the autonomic nervous system (ANS) and reflects activity in the parasympathetic (PNS) division. HRV is perturbed by stress and can be altered long-term when adversity is prevalent. As such, it has been associated with symptoms of affective and traumatic stress disorders and externalizing behaviors. We will non-invasively monitor the reactivity of HRV using an earlobe sensor to index the PNS. Participants will complete the Trier Social Stress Task (TSST), which is a standard protocol for inducing moderate psychosocial stress in laboratory settings, and has been widely used with preadolescents and adolescents (Gunnar, Wewerka, Frenn, Long, & Griggs, 2009; Kirschbaum, Pirke, & Hellhammer, 1993). The protocol involves preparing and delivering a speech by the participant in the presence of an adult experimenter and while being videotaped. The trained research assistant is instructed to be as non-responsive as possible during the task.

Secondary outcomes

  1. Child Behavior Checklist:

    Time frame: 10 minutes

    CBCL/4-18 has strong internal consistency and reliability. Considered the standard in field of child psychopathology.

  2. Strengths and Difficulties Questionnaire

    Time frame: 8 minutes

    A 31-item teacher-rated measure assessing aspects of students' social-emotional functioning. We will administer scales for dysregulation and social-emotional competence (13 items total).

  3. Patient-Reported Outcomes Measurement Information System

    Time frame: 6 minutes

    PROMIS is well established and widely used. Includes Depression, Anxiety, Emotional and Behavioral Dyscontrol, Sleep Disturbance, Well Being and Cognitive Function Scales for pediatric samples, from 8-17.

  4. Child PTSD Symptom Scale

    Time frame: 3 minutes

    The CPSS (Foa et al., 2001), which is a 25-item measure of trauma symptoms that has been shown to have good reliability and validity in Baltimore City youth, and has been used in prior studies conducted in Baltimore City public schools.

  5. Emotion Regulation Questionnaire

    Time frame: 3 minutes

    ERQ has 10 items rated on 7-point scale tap individual differences in habitual use of 2 emotion regulation strategies: cognitive reappraisal & expressive suppression (α = .69)

  6. Background Questionnaire

    Time frame: 3 minutes

    Gender, household income, ethnicity/race, mental health treatment received, coping, diet, sleep patterns, etc.

  7. Youth Risk Behavior Survey

    Time frame: 10 minutes

    The YRBS (CDC 2015) includes substance use items, which includes 4 items measuring lifetime use of alcohol, tobacco, and marijuana.

  8. Brief COPE

    Time frame: 5 minutes

    Brief COPE (Carver, 1997), a 28-item measure of various coping skills, including both adaptive and maladaptive coping strategies.

  9. Perceived Stress Scale

    Time frame: 3 minutes

    Perceived Stress Scale: 12 items modified from NIH toolbox (e.g. felt nervous and stressed; able to control irritations). α = 0.89

  10. Child and Adolescent Mindfulness Measure

    Time frame: 3 minutes

    Child and Adolescent Mindfulness Measure (CAMM) (Greco et al., 2011), a brief (10-item) measure of mindfulness that has been found to be reliable and valid in a sample of Baltimore City adolescents. This measure would be given at baseline and post-program, as well as the midpoint of the intervention.

  11. Adverse Childhood Experiences Checklist

    Time frame: 3 minutes

    Adverse Childhood Experiences Checklist (ACEs) (Felitti et al., 1998), a brief (8-item) checklist of trauma exposures adapted from a longer version to exclude items that would require reporting.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • Johns Hopkins Bloomberg School of Public Health
  • University of Cincinnati
  • University of North Carolina, Chapel Hill

Registry information

Official study title

Optimizing a Mindful Intervention for Urban Minority Youth Via Stress Physiology

Acronym: THAW

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 18, 2019
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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