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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT05701111
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
11 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Start with the Heart Students — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.
  • iSWAB-DNA — GENETIC
    Eligible students will give DNA buccal swabs at 2-3 time points for later analysis of genetic markers.

Study Details

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.

Key Dates

Start date
Feb 23, 2024
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
80,800 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness Curriculum
    Participants will undergo a mindfulness curriculum in the classroom for 6-8 weeks and complete surveys before the start and after completion.
  • Experimental: Teachers
    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.
  • Experimental: Counselors
    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.
  • Experimental: CCT
    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.
  • Other: iSWAB-DNA
    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.

Primary Outcome Measure

Mean Change from Baseline in Resilience Score [ Time Frame: Three time points: Baseline, week 8, week 23 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Lab Administrator
[email protected]
650-721-3582

Find similar trials in Palo Alto, CA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Stanford University· Palo Alto, CA

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