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NCT05701111 · ClinicalTrials.gov registry record · NA

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

A NA study of Stress and Post Traumatic Stress Disorder, sponsored by Stanford University.

Recruiting
Registry status
NA
Development phase
80,800
Enrollment target
3
Study locations

NCT05701111 is a NA study of Stress and Post Traumatic Stress Disorder that is actively recruiting participants, run by Stanford University. The registered enrollment target is 80,800 participants, above the 255-participant average among 152 other Stress trials with a reported enrollment target (31586% higher). The trial reports 3 study locations across 3 states.

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The verdict

NCT05701111, a NA study of Stress and Post Traumatic Stress Disorder, is actively recruiting participants, sponsored by Stanford University.

RECRUITING
Registry status
NA
Development phase
80,800 participants
Enrollment target
3
Study locations

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

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

FieldValue
Enrollment Target 80,800 participants
Start Date 2024-02-23
Est. Completion 2027-05
Phase NA

Sponsor

Stanford University

1,744 total trials

What the Registry Record Tells You About NCT05701111

The ClinicalTrials.gov registry entry for NCT05701111 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80,800 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 255-participant average among 152 other Stress trials with a reported enrollment target (31586% higher). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.

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.

NCT05701111 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Puerto Rico, Other.

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.

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).

Who is sponsoring clinical trial NCT05701111?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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