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

Stanford University

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05701111

IRB-67441

Details and patient eligibility

About

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.

Enrollment: 80,800 estimated patients

Sex: All

Ages: 11 to 17 years old

Volunteers: Accepts Healthy Volunteers

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:

2. Students doing current trauma-focused interventions with a mental health professional

3. Low cognitive functioning (IQ less than 70)

4. Substance dependence as defined by DSM criteria

5. Autism/Schizophrenia

6. Clinically significant medical illness

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

80,800 participants in 5 patient groups

Mindfulness Curriculum

Experimental group

Description:

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

Treatment:

Behavioral: Start with the Heart Students

Teachers

Experimental group

Description:

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.

Treatment:

Behavioral: Start with the Heart Teachers

Counselors

Experimental group

Description:

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.

Treatment:

Behavioral: Cue Centered Therapy Counselors

CCT

Experimental group

Description:

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.

Treatment:

Behavioral: Cue Centered Therapy Students

iSWAB-DNA

Other group

Description:

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.

Treatment:

Behavioral: Cue Centered Therapy Students

Behavioral: Start with the Heart Students

Genetic: iSWAB-DNA