Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress
NCT05701111 · View on ClinicalTrials.gov ↗
Study 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-in
Conditions Studied
Interventions
- BEHAVIORAL Start with the Heart Students
- BEHAVIORAL Start with the Heart Teachers
- BEHAVIORAL Cue Centered Therapy Counselors
- BEHAVIORAL Cue Centered Therapy Students
- GENETIC iSWAB-DNA
Study Locations (3)
California
- Stanford University — Palo Alto
Puerto Rico
- Centros Sor Isolina Ferre — San Juan
Other
- Department of Education Puerto Rico — San Juan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80,800 participants |
| Start Date | 2024-02-23 |
| Est. Completion | 2027-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05701111
The ClinicalTrials.gov registry entry for NCT05701111 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 80,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Stress appearing as the primary indexed condition, and to 5 interventions — of which Start with the Heart Students is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05701111 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Puerto Rico, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05701111 about?
NCT05701111 is a clinical study titled "Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress". 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 inc...
What is the current status of trial NCT05701111?
This trial is currently recruiting. It is a NA study. The enrollment target is 80,800 participants. The study started on 2024-02-23. Estimated completion is 2027-05.
What conditions does trial NCT05701111 study?
This clinical trial studies the following conditions: Stress, Post Traumatic Stress Disorder, Mental Health Issue, Burn Out, Complex Posttraumatic Stress Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05701111?
The interventions under investigation include: Start with the Heart Students (BEHAVIORAL), Start with the Heart Teachers (BEHAVIORAL), Cue Centered Therapy Counselors (BEHAVIORAL), Cue Centered Therapy Students (BEHAVIORAL), iSWAB-DNA (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05701111?
This trial is sponsored by Stanford University, which has 1,643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05701111 being conducted?
This trial has 3 study locations across California, Puerto Rico. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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