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

NCT05701111 | Recruiting FDA Device

• 1 other identifier: IRB-67441
• Study Type: interventional
• Target: 80,800
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Mean Change from Baseline in Resilience Score

  Resilience is assessed using the Child/Youth and Adult Resilience Measure on a 5- point Likert scale. Score range 1 to 5 (1=Not at all, 5=A lot). The total score is summed. Changes in scores will be assessed between all time points.

  Three time points: Baseline, week 8, week 23

• Mean Change from Baseline in Work Self-Efficacy Score

  Work Self-Efficacy is assessed on a 5- point Likert scale. Score range 1 to 5 (1=Not well at all, 5=Very Well). The total score is summed. Changes in scores will be assessed between all time points.

  Teachers: Baseline, week 8; Counselors: Baseline, week 23

• Mean Change from Baseline in Anxiety Score

  Generalized Anxiety Disorder (GAD) symptoms are assessed using the GAD-7 on a 4- point Likert scale. Score range 0 to 3 (0=Not at all, 3=Nearly every day). Total score is summed. Changes in scores will be assessed between all time points.

  Three time points: Baseline, week 8, week 23

• Mean Change from Baseline in Depression Score

  Depression is assessed using the Patient Health Questionnaire (PHQ)-8 on a 4- point Likert scale. Score range 0 to 3 (0=Not at all, 3=Nearly every day). Total score is summed. Changes in scores will be assessed between all time points.

  Three time points: Baseline, week 8, week 23

• Mean Change from Baseline in Somatic Symptoms Score

  Somatic symptoms are assessed using the PHQ-15 on a 3- point Likert scale. Score range 0 to 2 (0=Not bothered at all, 2=Bothered a lot). Total score is summed. Changes in scores will be assessed between all time points.

  Three time points: Baseline, week 8, week 23

• Changes in Methylation Pattern of Genes

  Using DNA methylation to analyze DNA samples from buccal swabs to investigate genetic markers of resilience. Genetic markers to be analyzed include: CTNNB1, ITGB8, CSRP2, WTAP, TSC22D1, HNRNPH1, NTRK2, DCX, CDK14, PTNN, SLC1A3, IGFBP2, ERBB4. Changes in genetic expressions will be assessed between all time points.

  Three time points: Baseline, week 8, week 23

Secondary Outcomes (2)

• Mean Change from Baseline in Family Functioning Score

  Three time points: Baseline, week 8, week 23

• Mean Change from Baseline in Sleep Quality Score

  Three time points: Baseline, week 8, week 23

Study Arms (5)

Mindfulness Curriculum

EXPERIMENTAL

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

Behavioral: Start with the Heart Students

Teachers

EXPERIMENTAL

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.

Behavioral: Start with the Heart Teachers

Counselors

EXPERIMENTAL

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.

Behavioral: Cue Centered Therapy Counselors

CCT

EXPERIMENTAL

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.

Behavioral: Cue Centered Therapy Students

iSWAB-DNA

OTHER

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.

Behavioral: Start with the Heart Students; Behavioral: Cue Centered Therapy Students; Genetic: iSWAB-DNA

Interventions

Start with the Heart Students 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.

Mindfulness Curriculum; iSWAB-DNA

Start with the Heart Teachers 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.

Teachers

Cue Centered Therapy Counselors 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.

Counselors

Cue Centered Therapy Students 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.

CCT; iSWAB-DNA

iSWAB-DNA GENETIC

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

iSWAB-DNA

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Teachers and students at a participating school site, Adults and students/caregivers willing to participate in the study
• For Cue Centered Therapy:
• 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.
• Willingness to participate in therapy
• Caregiver willing to participate in therapy
• Perpetrator of the traumatic event is not living in the home with the child

You may not qualify if:

• \. For the general study and for Cue Centered Therapy:
• Students doing current trauma-focused interventions with a mental health professional
• Low cognitive functioning (IQ less than 70)
• Substance dependence as defined by DSM criteria
• Autism/Schizophrenia
• Clinically significant medical illness

Sponsors & Collaborators

• Stanford University: lead
• Pure Edge Inc.: collaborator
• Iowa State University: collaborator
• Ponce Health Sciences University: collaborator

Study Sites (3)

Stanford University

Palo Alto, California, 94305, United States

NOT YET RECRUITING

Centros Sor Isolina Ferre

San Juan, Puerto Rico, 00926, Puerto Rico

SUSPENDED

Department of Education Puerto Rico

San Juan, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Victor Carrion, M.D.

  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

  PRINCIPAL INVESTIGATOR

• Alexander Urban, Ph.D.

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lab Adminstrator

CONTACT

(650) 721-3582; elsrp_contact@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice-Chair of Psychiatry and Behavioral Sciences

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 27, 2023
• Study Start: February 23, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PR (2); US (1)