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临床试验/NCT05701111
NCT05701111招募中不适用

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

Stanford University5 个研究点 分布在 2 个国家目标入组 80,800 人开始时间: 2024年2月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80,800
试验地点
5
主要终点
Mean Change from Baseline in Work Self-Efficacy Score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Mindfulness Curriculum

Experimental

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

干预措施: Start with the Heart Students (Behavioral)

Teachers

Experimental

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.

干预措施: Start with the Heart Teachers (Behavioral)

Counselors

Experimental

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.

干预措施: Cue Centered Therapy Counselors (Behavioral)

CCT

Experimental

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.

干预措施: Cue Centered Therapy Students (Behavioral)

iSWAB-DNA

Other

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.

干预措施: Start with the Heart Students (Behavioral)

iSWAB-DNA

Other

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.

干预措施: Cue Centered Therapy Students (Behavioral)

iSWAB-DNA

Other

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.

干预措施: iSWAB-DNA (Genetic)

结局指标

主要结局

Mean Change from Baseline in Work Self-Efficacy Score

时间窗: Teachers: Baseline, week 8; Counselors: Baseline, week 23

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 Resilience Score

时间窗: Three time points: Baseline, week 8, week 23

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 Somatic Symptoms Score

时间窗: Three time points: Baseline, week 8, week 23

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.

Mean Change from Baseline in Anxiety Score

时间窗: Three time points: Baseline, week 8, week 23

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

时间窗: Three time points: Baseline, week 8, week 23

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.

Changes in Methylation Pattern of Genes

时间窗: Three time points: Baseline, week 8, week 23

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.

次要结局

  • Mean Change from Baseline in Sleep Quality Score(Three time points: Baseline, week 8, week 23)
  • Mean Change from Baseline in Family Functioning Score(Three time points: Baseline, week 8, week 23)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Victor Carrion

Professor and Vice-Chair of Psychiatry and Behavioral Sciences

Stanford University

研究点 (5)

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