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Teenage Health and Wellness Study (THAW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03989934
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : June 18, 2019
Sponsor:
Collaborators:
Johns Hopkins Bloomberg School of Public Health
University of Cincinnati
University of North Carolina, Chapel Hill
Information provided by (Responsible Party):
Diana Fishbein, Penn State University

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.

Condition or disease Intervention/treatment Phase
Stress Externalizing Symptoms Depression Symptoms Anxiety Behavioral: The Mind in Action Behavioral: Healthy Topics Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Optimizing a Mindful Intervention for Urban Minority Youth Via Stress Physiology
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: The Mind in Action
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).
Behavioral: The Mind in Action
Mindfulness program for adolescents

Active Comparator: Healthy Topics
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.
Behavioral: Healthy Topics
Health education program for adolescents




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989934


Contacts
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Contact: Diana H Fishbein, PhD 814-865-7377 dfishbein@psu.edu
Contact: Tamar Mendelson, PhD 717-475-9494 tmendel1@jhsph.edu

Locations
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United States, Maryland
Baltimore City Public Schools Recruiting
Baltimore, Maryland, United States, 21202
Contact: Tamar Mendelson, PhD    410-502-6219    tmendel1@jhu.edu   
Contact: Jessica Bair, PhD    717-475-9494    jbair@c-trans.org   
Sponsors and Collaborators
Penn State University
Johns Hopkins Bloomberg School of Public Health
University of Cincinnati
University of North Carolina, Chapel Hill
Investigators
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Principal Investigator: Tamar Mendelson, PhD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Diana Fishbein, PhD Penn State University
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Responsible Party: Diana Fishbein, Professor, Department of Human Development and Family Studies, Penn State University
ClinicalTrials.gov Identifier: NCT03989934    
Other Study ID Numbers: R61AT009856 ( U.S. NIH Grant/Contract )
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Diana Fishbein, Penn State University:
mindfulness; stress physiology; urban youth
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms