RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-23
Study Completion:2026-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05701111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Teachers and students at a participating school site, Adults and students/caregivers willing to participate in the study
  2. 2. For Cue Centered Therapy:
  3. 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.
  4. 2. Willingness to participate in therapy
  5. 3. Caregiver willing to participate in therapy
  6. 4. Perpetrator of the traumatic event is not living in the home with the child
  1. 1. For the general study and for Cue Centered Therapy:
  2. 1. Students doing current trauma-focused interventions with a mental health professional
  3. 2. Low cognitive functioning (IQ less than 70)
  4. 3. Substance dependence as defined by DSM criteria
  5. 4. Autism/Schizophrenia
  6. 5. Clinically significant medical illness

Contacts and Locations

Study Contact

Emily Lab Manager
CONTACT
(650) 724- 6598
emilywu@stanford.edu
Elizabeth Lab Administrator
CONTACT
(650) 721-3582
eliz5@stanford.edu

Principal Investigator

Victor Carrion, M.D.
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
Hilit Kletter, Ph.D.
PRINCIPAL_INVESTIGATOR
Clinical Associate Professor
Alexander Urban, Ph.D.
PRINCIPAL_INVESTIGATOR
Associate Professor

Study Locations (Sites)

Stanford University
Palo Alto, California, 94305
United States

Collaborators and Investigators

Sponsor: Stanford University

  • Victor Carrion, M.D., 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
  • Hilit Kletter, Ph.D., PRINCIPAL_INVESTIGATOR, Clinical Associate Professor
  • Alexander Urban, Ph.D., PRINCIPAL_INVESTIGATOR, Associate Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-23
Study Completion Date2026-05

Study Record Updates

Study Start Date2024-02-23
Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

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