StressTHAWNCT03989934
Teenage Health and Wellness Study
A study testing The Mind in Action and Healthy Topics in people with Stress and Externalizing Symptoms, run by Penn State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Externalizing Symptoms, Depression Symptoms
- What is being tested?
- The Mind in Action and Healthy Topics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2019to 22 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be in the 9th grade at one of the Baltimore City Public Schools participating in the study
- Must provide parental permission and assent.
Who cannot join
- Students in foster care
- Students in self-contained special education classrooms
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore City Public Schools
Baltimore, Maryland, 21202
About this study
Official title: Optimizing a Mindful Intervention for Urban Minority Youth Via Stress Physiology
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.
Read the 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
- Being tested
- The Mind in Action, Healthy Topics
- Keywords
- mindfulness; stress physiology; urban youth
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Mind in ActionBehavioural
Mindfulness program for adolescents
Healthy TopicsBehavioural
Health education program for adolescents
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Healthy Topics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 25 minutes
Secondary outcomes (11)
Child Behavior Checklist:
CBCL/4-18 has strong internal consistency and reliability. Considered the standard in field of child psychopathology.
Measured: 10 minutes
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).
Measured: 8 minutes
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.
Measured: 6 minutes
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.
Measured: 3 minutes
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 (α = .69)
Measured: 3 minutes
Background Questionnaire
Gender, household income, ethnicity/race, mental health treatment received, coping, diet, sleep patterns, etc.
Measured: 3 minutes
Youth Risk Behavior Survey
The YRBS (CDC 2015) includes substance use items, which includes 4 items measuring lifetime use of alcohol, tobacco, and marijuana.
Measured: 10 minutes
Brief COPE
Brief COPE (Carver, 1997), a 28-item measure of various coping skills, including both adaptive and maladaptive coping strategies.
Measured: 5 minutes
Perceived Stress Scale
Perceived Stress Scale: 12 items modified from NIH toolbox (e.g. felt nervous and stressed; able to control irritations). α = 0.89
Measured: 3 minutes
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.
Measured: 3 minutes
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.
Measured: 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start5 Feb 2019
- Primary completion31 May 2022
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, University of Cincinnati, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Diana Fishbein, Penn State University
- Investigators
- Tamar Mendelson, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public HealthDiana Fishbein, PhD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989934
- Sponsor's protocol ID
- R61AT009856
- Acronym
- THAW
- Status last verified
- Jan 2023
- First submitted
- 17 Jun 2019
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40771868
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing a Mindful Intervention for Urban Minority Youth Via Stress Physiology
- ClinicalTrials.gov ID
- NCT03989934
- Acronym / sponsor ID
- THAW / R61AT009856
- Conditions
- Stress, Externalizing Symptoms, Depression Symptoms, Anxiety
- Keywords
- mindfulness; stress physiology; urban youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- Johns Hopkins Bloomberg School of Public Health, University of Cincinnati, University of North Carolina, Chapel Hill
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 18 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Mind in Action | Experimental | Behavioral: The Mind in ActionThe 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). |
| Healthy Topics | Active comparator | Behavioral: Healthy TopicsAdapted 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. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Must be in the 9th grade at one of the Baltimore City Public Schools participating in the study
- Must provide parental permission and assent.
Key exclusion criteria (2 listed)
- Students in foster care
- Students in self-contained special education classrooms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Mind in ActionMindfulness program for adolescents | Behavioural | The Mind in Action |
| Healthy TopicsHealth education program for adolescents | Behavioural | Healthy Topics |
Primary outcome
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.
11 secondary outcomes
Child Behavior Checklist:
Time frame: 10 minutes
Strengths and Difficulties Questionnaire
Time frame: 8 minutes
Patient-Reported Outcomes Measurement Information System
Time frame: 6 minutes
Child PTSD Symptom Scale
Time frame: 3 minutes
Emotion Regulation Questionnaire
Time frame: 3 minutes
Background Questionnaire
Time frame: 3 minutes
Youth Risk Behavior Survey
Time frame: 10 minutes
Brief COPE
Time frame: 5 minutes
Perceived Stress Scale
Time frame: 3 minutes
Child and Adolescent Mindfulness Measure
Time frame: 3 minutes
Adverse Childhood Experiences Checklist
Time frame: 3 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Derived from this study: PubMed 40771868Dariotis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamar Mendelson, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
Diana Fishbein, PhD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Mind in Action and Healthy Topics in people with Stress and Externalizing Symptoms, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (HRV) (time frame: 25 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03989934, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.