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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701111
• Other study ID #: IRB-67441
• Status: Recruiting
• Phase: N/A
• Start date: February 23, 2024
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: Stanford University
• Contact: Emily Lab Manager
• Phone: (650) 724- 6598
• Email: emilywu[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80800
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Out
• Mental Health Issue
• Post Traumatic Stress Disorder
• Stress
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• 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.
• 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.
• 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.
• 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.

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

Locations

Country	Name	City	State
Puerto Rico	Centros Sor Isolina Ferre	San Juan
United States	Stanford University	Palo Alto	California

Sponsors (4)

Lead Sponsor	Collaborator
Stanford University	Iowa State University, Ponce Health Sciences University, Pure Edge Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Mean Change from Baseline in Family Functioning Score	Family functioning are assessed using the Family Assessment Device on a 4- point Likert scale. Score range 1 to 4 (1=Strongly Agree, 4=Strongly Disagree). Unhealthy responses are reverse-scored and each subscale is averaged. Only the General Functioning subscale will be used for the study. Changes in scores will be assessed between all time points.	Three time points: Baseline, week 8, week 23
Secondary	Mean Change from Baseline in Sleep Quality Score	Sleep quality is assessed using the Brief-Pittsburgh Sleep Quality Index. Questions are open answer (i.e. When have you usually gone to bed at night? How many hours of actual sleep did you get at night?). Total score is calculated by summing subscores of sleep duration, latency, day dysfunction, sleep efficiency, sleep quality, and meds. Changes in scores will be assessed between all time points.	Three time points: Baseline, week 8, week 23