Clinical trial NCT05701111: Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress
Official title: Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Complex Posttraumatic Stress Disorder
Stress
Burn Out
Mental Health Issue
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Pure Edge Inc.
name: Iowa State University
name: Ponce Health Sciences University
First posted: 2023-01-27
Enrollment: 80800
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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 purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change from Baseline in Resilience Score
timeFrame: Three time points: Baseline, week 8, week 23
measure: Mean Change from Baseline in Work Self-Efficacy Score
timeFrame: Teachers: Baseline, week 8; Counselors: Baseline, week 23
measure: Mean Change from Baseline in Anxiety Score
timeFrame: Three time points: Baseline, week 8, week 23
measure: Mean Change from Baseline in Depression Score
timeFrame: Three time points: Baseline, week 8, week 23
measure: Mean Change from Baseline in Somatic Symptoms Score
timeFrame: Three time points: Baseline, week 8, week 23
measure: Changes in Methylation Pattern of Genes
timeFrame: Three time points: Baseline, week 8, week 23
Secondary outcomes:
measure: Mean Change from Baseline in Family Functioning Score
timeFrame: Three time points: Baseline, week 8, week 23
measure: Mean Change from Baseline in Sleep Quality Score
timeFrame: Three time points: Baseline, week 8, week 23
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Juan
country: Puerto Rico
facility: Centros Sor Isolina Ferre
Study officials:
affiliation: 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
name: Victor Carrion, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Alexander Urban, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: