Teenage Health and Wellness Study

NCT03989934 | Completed DMC

• 1 other identifier: R61AT009856
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Externalizing Symptoms; Depression Symptoms; Anxiety

Keywords

mindfulness; stress physiology; urban youth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Child Behavior Checklist:

  10 minutes

• Strengths and Difficulties Questionnaire

  8 minutes

• Patient-Reported Outcomes Measurement Information System

  6 minutes

• Child PTSD Symptom Scale

  3 minutes

• Emotion Regulation Questionnaire

  3 minutes

Study Arms (2)

The Mind in Action

EXPERIMENTAL

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

Healthy Topics

ACTIVE COMPARATOR

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

Interventions

The Mind in Action BEHAVIORAL

Mindfulness program for adolescents

The Mind in Action

Healthy Topics BEHAVIORAL

Health education program for adolescents

Healthy Topics

Eligibility Criteria

• Age: 13 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Must be in the 9th grade at one of the Baltimore City Public Schools participating in the study
• Must provide parental permission and assent.

You may not qualify if:

• Students in foster care
• Students in self-contained special education classrooms

Sponsors & Collaborators

• Penn State University: lead
• Johns Hopkins Bloomberg School of Public Health: collaborator
• University of Cincinnati: collaborator
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Baltimore City Public Schools

Baltimore, Maryland, 21202, United States

Location

Related Publications (1)

• 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.

  PMID: 40771868 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Tamar Mendelson, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Diana Fishbein, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Human Development and Family Studies

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 18, 2019
• Study Start: February 5, 2019
• Primary Completion: May 31, 2022
• Study Completion: June 22, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)