Teenage Health and Wellness Study

Anxiety Clinical Trial

— THAW  

Official title:

Optimizing a Mindful Intervention for Urban Minority Youth Via Stress Physiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03989934
• Other study ID #: R61AT009856
• Status: Completed
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: June 22, 2022

Study information

• Verified date: January 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: June 22, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depression Symptoms
• Externalizing Symptoms
• Stress

Intervention

Behavioral:
• The Mind in Action
Mindfulness program for adolescents
• Healthy Topics
Health education program for adolescents

Locations

Country	Name	City	State
United States	Baltimore City Public Schools	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Penn State University	Johns Hopkins Bloomberg School of Public Health, University of Cincinnati, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability (HRV)	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.	25 minutes
Secondary	Child Behavior Checklist:	CBCL/4-18 has strong internal consistency and reliability. Considered the standard in field of child psychopathology.	10 minutes
Secondary	Strengths and Difficulties Questionnaire	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).	8 minutes
Secondary	Patient-Reported Outcomes Measurement Information System	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.	6 minutes
Secondary	Child PTSD Symptom Scale	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.	3 minutes
Secondary	Emotion Regulation Questionnaire	ERQ has 10 items rated on 7-point scale tap individual differences in habitual use of 2 emotion regulation strategies: cognitive reappraisal & expressive suppression (a = .69)	3 minutes
Secondary	Background Questionnaire	Gender, household income, ethnicity/race, mental health treatment received, coping, diet, sleep patterns, etc.	3 minutes
Secondary	Youth Risk Behavior Survey	The YRBS (CDC 2015) includes substance use items, which includes 4 items measuring lifetime use of alcohol, tobacco, and marijuana.	10 minutes
Secondary	Brief COPE	Brief COPE (Carver, 1997), a 28-item measure of various coping skills, including both adaptive and maladaptive coping strategies.	5 minutes
Secondary	Perceived Stress Scale	Perceived Stress Scale: 12 items modified from NIH toolbox (e.g. felt nervous and stressed; able to control irritations). a = 0.89	3 minutes
Secondary	Child and Adolescent Mindfulness Measure	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.	3 minutes
Secondary	Adverse Childhood Experiences Checklist	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.	3 minutes