Teenage Health and Wellness Study

NCT ID: NCT03989934

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 203 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-05
• Study Completion Date: 2022-06-22

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.

Conditions

Stress; Externalizing Symptoms; Depression Symptoms; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

The Mind in Action

Intervention Type: BEHAVIORAL

Mindfulness program for adolescents

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.

Group Type: ACTIVE_COMPARATOR

Healthy Topics

Intervention Type: BEHAVIORAL

Health education program for adolescents

Interventions

The Mind in Action

Mindfulness program for adolescents

Intervention Type: BEHAVIORAL

Healthy Topics

Health education program for adolescents

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

Diana Fishbein

Professor, Department of Human Development and Family Studies

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tamar Mendelson, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Diana Fishbein, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Baltimore City Public Schools

Baltimore, Maryland, United States

Countries

United States

References

Dariotis JK, Mabisi K, Jackson-Gordon R, Rose EJ, Fishbein DH, Mendelson T. Perceived Benefits of Mindfulness and Health Education Programs for Minoritized Adolescents: A Qualitative Analysis. Mindfulness (N Y). 2023 Jun;14(6):1346-1361. doi: 10.1007/s12671-023-02147-y. Epub 2023 Jun 8.

Reference Type: DERIVED

PMID: 40771868 (View on PubMed)

Other Identifiers

R61AT009856

Identifier Type: NIH

Identifier Source: org_study_id

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