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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Mean Change from Baseline in Resilience Score [Срок оценки: Three time points: Baseline, week 8, week 23]
• Mean Change from Baseline in Work Self-Efficacy Score [Срок оценки: Teachers: Baseline, week 8; Counselors: Baseline, week 23]
• Mean Change from Baseline in Anxiety Score [Срок оценки: Three time points: Baseline, week 8, week 23]
• Mean Change from Baseline in Depression Score [Срок оценки: Three time points: Baseline, week 8, week 23]
• Mean Change from Baseline in Somatic Symptoms Score [Срок оценки: Three time points: Baseline, week 8, week 23]
• Changes in Methylation Pattern of Genes [Срок оценки: Three time points: Baseline, week 8, week 23]

Вторичные конечные точки (2)

• Mean Change from Baseline in Family Functioning Score [Срок оценки: Three time points: Baseline, week 8, week 23]
• Mean Change from Baseline in Sleep Quality Score [Срок оценки: Three time points: Baseline, week 8, week 23]

Критерии участия

Критерии включения

• 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

Критерии исключения

1\. 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пуэрто-Рико · 2 центра

• Centros Sor Isolina Ferre — San Juan
• Department of Education Puerto Rico — San Juan

США · 1 центр

• Stanford University — Palo Alto

Идентификаторы

NCT: NCT05701111 · IRB-67441

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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