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

Primary Purpose

Post Traumatic Stress Disorder, Complex Posttraumatic Stress Disorder, Stress

Status
Not yet recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Start with the Heart Students
Start with the Heart Teachers
Cue Centered Therapy Counselors
Cue Centered Therapy Students
iSWAB-DNA
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Stanford University
  • Puerto Rico Department of Education School District

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Mindfulness Curriculum

Teachers

Counselors

CCT

iSWAB-DNA

Arm Description

Participants will undergo a mindfulness curriculum in the classroom for 6-8 weeks and complete surveys before the start and after completion.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 19, 2022
Last Updated
August 12, 2023
Sponsor
Stanford University
Collaborators
Pure Edge Inc., Iowa State University, Ponce Health Sciences University
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1. Study Identification

Unique Protocol Identification Number
NCT05701111
Brief Title
Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress
Official Title
Building Resilience at Schools: Emotional and Biological Assessment and Treatment of Traumatic Stress
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Pure Edge Inc., Iowa State University, Ponce Health Sciences University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder, Complex Posttraumatic Stress Disorder, Stress, Burn Out, Mental Health Issue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
At Time 1, all participating students undergo a mindfulness curriculum in the classroom, and a subset that reports PTSD symptomatology will continue to receive Cue Centered Therapy at TIme 2 after completing the mindfulness curriculum. A subset of Time 1 students will be randomly selected for DNA buccal swabs at all three time points. All participating teachers undergo training for and implementation of the mindfulness curriculum. All participating counselors undergo training for and implementation of Cue-Centered Therapy.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Curriculum
Arm Type
Experimental
Arm Description
Participants will undergo a mindfulness curriculum in the classroom for 6-8 weeks and complete surveys before the start and after completion.
Arm Title
Teachers
Arm Type
Experimental
Arm Description
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.
Arm Title
Counselors
Arm Type
Experimental
Arm Description
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.
Arm Title
CCT
Arm Type
Experimental
Arm Description
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.
Arm Title
iSWAB-DNA
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Start with the Heart Students
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Start with the Heart Teachers
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cue Centered Therapy Counselors
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cue Centered Therapy Students
Intervention Description
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.
Intervention Type
Genetic
Intervention Name(s)
iSWAB-DNA
Intervention Description
Eligible students will give DNA buccal swabs at 2-3 time points for later analysis of genetic markers.
Primary Outcome Measure Information:
Title
Mean Change from Baseline in Resilience Score
Description
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.
Time Frame
Three time points: Baseline, week 8, week 23
Title
Mean Change from Baseline in Work Self-Efficacy Score
Description
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.
Time Frame
Teachers: Baseline, week 8; Counselors: Baseline, week 23
Title
Mean Change from Baseline in Anxiety Score
Description
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.
Time Frame
Three time points: Baseline, week 8, week 23
Title
Mean Change from Baseline in Depression Score
Description
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.
Time Frame
Three time points: Baseline, week 8, week 23
Title
Mean Change from Baseline in Somatic Symptoms Score
Description
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.
Time Frame
Three time points: Baseline, week 8, week 23
Title
Changes in Methylation Pattern of Genes
Description
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.
Time Frame
Three time points: Baseline, week 8, week 23
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in Family Functioning Score
Description
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.
Time Frame
Three time points: Baseline, week 8, week 23
Title
Mean Change from Baseline in Sleep Quality Score
Description
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.
Time Frame
Three time points: Baseline, week 8, week 23

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Lab Manager
Phone
(650) 724- 6598
Email
emilywu@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Lab Administrator
Phone
(650) 721-3582
Email
eliz5@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Carrion, M.D.
Organizational Affiliation
John A. Turner, M.D. Professor and Vice-Chair of Psychiatry and Behavioral Sciences at Stanford University and Director of the Stanford Early Life Stress and Resilience Program
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hilit Kletter, Ph.D.
Organizational Affiliation
Clinical Associate Professor
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Urban, Ph.D.
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Wu
Phone
650-724-6598
Email
emilywu@stanford.edu
Facility Name
Puerto Rico Department of Education School District
City
San Juan
ZIP/Postal Code
00919-0759
Country
Puerto Rico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elieser R Parés
Phone
787-773-5800
Email
Ramospr@de.pr.gov

12. IPD Sharing Statement

Plan to Share IPD
No

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

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