Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-23

Study Completion Date

2027-05-31

Brief Summary

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In the last four years alone, residents of Puerto Rico have experienced a slew of natural disasters including Hurricane Maria in 2017, earthquakes in 2019 and 2020, the continued COVID-19 pandemic from 2020-2022, and most recently Hurricane Fiona. This series of distressing events can lead to an increased need for mental health resources and trauma treatment. Furthermore, the unique single-district structure of the Puerto Rican education system allows for the efficient dissemination of potential interventions and treatment to all students.

The purpose of this study is to examine two treatment conditions for educators and school-aged children in Puerto Rico experiencing burnout, fatigue, and high stress: delivery of a mindfulness-based educator curriculum and, for children who report Post Traumatic Stress Disorder (PTSD) symptomatology, delivery of the mindfulness curriculum with the additional intervention of Cue-Centered Therapy (CCT). The study has two aims: 1) To assess the efficacy of the mindfulness curriculum and of CCT in a population of students, counselors, and teachers, characterized by high stress over the last few years of natural disasters and pandemic challenges and 2) To identify genetic contributions to resilience by analyzing gene expression in students before and after the intervention.

The overarching goals of the investigators' research collaboration are to improve educators' psychological well-being and children's socioemotional development when faced with high stress and adversity and to improve mental health clinicians' competence and confidence in treating children exposed to trauma by training them in CCT. The investigators' research will identify critical biopsychosocial components responsible for the cognitive, behavioral, and emotional improvement and effective implementation strategies in a large but geographically dispersed school district. The knowledge base that will result from this study will inform the implementation of trauma-informed care in school settings and with populations experiencing stress and adversity, and contribute to the investigators' understanding of the underlying biology of these interventions to provide a rationale for further development and dissemination.

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Detailed Description

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Conditions

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Post Traumatic Stress Disorder Complex Posttraumatic Stress Disorder Stress Burn Out Mental Health Issue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

At Time 1, all participating students undergo a mindfulness curriculum in the classroom, and a subset that reports PTSD symptomatology will continue to receive Cue Centered Therapy at TIme 2 after completing the mindfulness curriculum. A subset of Time 1 students will be randomly selected for DNA buccal swabs at all three time points. All participating teachers undergo training for and implementation of the mindfulness curriculum. All participating counselors undergo training for and implementation of Cue-Centered Therapy.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness Curriculum

Participants will undergo a mindfulness curriculum in the classroom for 6-8 weeks and complete surveys before the start and after completion.

Group Type EXPERIMENTAL

Start with the Heart Students

Intervention Type BEHAVIORAL

The Start with the Heart curriculum includes psychoeducation, lessons, and activities, on mindfulness, neurobiology, meditation, positive thinking, movement, and nutrition to promote well-being. The curriculum will be taught in the classroom to students for 15-20 min per day for 6-8 weeks.

Teachers

Participants will be trained in the mindfulness curriculum and implement it in the classroom for 6-8 weeks. They will complete surveys before training and after implementation.

Group Type EXPERIMENTAL

Start with the Heart Teachers

Intervention Type BEHAVIORAL

Pure Edge Inc will train teachers to deliver the Start with the Heart curriculum. The training emphasizes the neuroscience of stress and educator self-care. The teachers will implement the training in their respective classrooms for 6-8 weeks.

Counselors

Participants will be trained in Cue-Centered Therapy and implement the treatment with student clients for 15-18 weeks. They will complete surveys before training and after 3 months after the start of implementation.

Group Type EXPERIMENTAL

Cue Centered Therapy Counselors

Intervention Type BEHAVIORAL

The Early Life Stress and Resilience Program team members will train school counselors on Cue-Centered Therapy through self-paced online modules, virtual and in-person live training, and office hours as needed. Counselors will implement the intervention with eligible students for 15-18 weeks.

CCT

Participants that report PTSD symptomatology during the mindfulness curriculum surveys will be eligible to participate in Cue-Centered Therapy treatment for 15-18 weeks. They will complete surveys before and after treatment.

Group Type EXPERIMENTAL

Cue Centered Therapy Students

Intervention Type BEHAVIORAL

Students who report a threshold of PTSD symptoms will be offered participation in Cue-Centered Therapy with their school counselors. They will have one-on-one therapy that targets trauma experiences through cognitive behavioral tools, narrative therapy, exposure therapy, psychoeducation, and more. Their caregivers will be involved as needed. They will enroll in treatment for 15-18 weeks.

iSWAB-DNA

Students that give prior consent to participating in DNA buccal swabs and the mindfulness curriculum are randomly selected to give buccal swabs prior to and after the mindfulness curriculum intervention. A subset of those students that qualify for CCT will give another buccal swab after CCT completion. DNA will be sent to Dr. Urban's lab for analysis of genetic resilience markers.

Group Type OTHER

Start with the Heart Students

Intervention Type BEHAVIORAL

The Start with the Heart curriculum includes psychoeducation, lessons, and activities, on mindfulness, neurobiology, meditation, positive thinking, movement, and nutrition to promote well-being. The curriculum will be taught in the classroom to students for 15-20 min per day for 6-8 weeks.

Cue Centered Therapy Students

Intervention Type BEHAVIORAL

Students who report a threshold of PTSD symptoms will be offered participation in Cue-Centered Therapy with their school counselors. They will have one-on-one therapy that targets trauma experiences through cognitive behavioral tools, narrative therapy, exposure therapy, psychoeducation, and more. Their caregivers will be involved as needed. They will enroll in treatment for 15-18 weeks.

iSWAB-DNA

Intervention Type GENETIC

Eligible students will give DNA buccal swabs at 2-3 time points for later analysis of genetic markers.

Interventions

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Start with the Heart Students

The Start with the Heart curriculum includes psychoeducation, lessons, and activities, on mindfulness, neurobiology, meditation, positive thinking, movement, and nutrition to promote well-being. The curriculum will be taught in the classroom to students for 15-20 min per day for 6-8 weeks.

Intervention Type BEHAVIORAL

Start with the Heart Teachers

Pure Edge Inc will train teachers to deliver the Start with the Heart curriculum. The training emphasizes the neuroscience of stress and educator self-care. The teachers will implement the training in their respective classrooms for 6-8 weeks.

Intervention Type BEHAVIORAL

Cue Centered Therapy Counselors

The Early Life Stress and Resilience Program team members will train school counselors on Cue-Centered Therapy through self-paced online modules, virtual and in-person live training, and office hours as needed. Counselors will implement the intervention with eligible students for 15-18 weeks.

Intervention Type BEHAVIORAL

Cue Centered Therapy Students

Students who report a threshold of PTSD symptoms will be offered participation in Cue-Centered Therapy with their school counselors. They will have one-on-one therapy that targets trauma experiences through cognitive behavioral tools, narrative therapy, exposure therapy, psychoeducation, and more. Their caregivers will be involved as needed. They will enroll in treatment for 15-18 weeks.

Intervention Type BEHAVIORAL

iSWAB-DNA

Eligible students will give DNA buccal swabs at 2-3 time points for later analysis of genetic markers.

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

1. Teachers and students at a participating school site, Adults and students/caregivers willing to participate in the study
2. For Cue Centered Therapy:

1. Youth aged 11-17 with exposure to at least one Diagnostic Statistical Manual (DSM) 5-defined traumatic event and meeting threshold criteria for posttraumatic symptoms per the University of California Los Angeles (UCLA) PTSD scale.
2. Willingness to participate in therapy
3. Caregiver willing to participate in therapy
4. Perpetrator of the traumatic event is not living in the home with the child

Exclusion Criteria

1\. For the general study and for Cue Centered Therapy:

1. Students doing current trauma-focused interventions with a mental health professional
2. Low cognitive functioning (IQ less than 70)
3. Substance dependence as defined by DSM criteria
4. Autism/Schizophrenia
5. Clinically significant medical illness

Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Victor Carrion

Professor and Vice-Chair of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Victor Carrion, M.D.

Role: PRINCIPAL_INVESTIGATOR

John A. Turner, M.D. Professor and Vice-Chair of Psychiatry and Behavioral Sciences at Stanford University and Director of the Stanford Early Life Stress and Resilience Program