跳至主要内容
临床试验/NCT04529031
NCT04529031招募中不适用

Clinical and Biomolecular Characteristics of Reminder-Focused Positive-Psychiatry in Adolescent With Posttraumatic Stress Disorder

University of California, Los Angeles2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
To examine the impact of RFPP intervention on core PTSD symptoms

研究概览

简要总结

Objective: Posttraumatic stress disorder (PTSD) is a prevalent neuropsychiatric disorder in children and is associated with increased neurovascular inflammation, suicidality, adulthood mental health disorder, and major adverse events. Reminder focused positive psychiatry (RFPP) has been shown as well tolerated feasible trauma focused intervention that is associated with improved core PTSD symptoms, decreased severity of reactivity to PTSD trauma reminders, and increased vascular function. This study evaluates the clinical and biomolecular characteristics of RFPP in adolescents with PTSD.

Research Design/Overall Impact: After obtaining parents' informed consent and adolescent's assent, 60 adolescents aged 11-15 years old with PTSD, and free of known medical and other major psychiatric disorders will be recruited from the pool of eligible adolescents at Olive View UCLA Pediatrics Clinics (>3000 adolescents with PTSD). Eligible adolescents will be randomized to 1) RFPP group intervention, or 2) an attentional control condition (group process). Thirty subjects in each group will receive twice weekly telehealth intervention of either RFPP or group process, for 6 weeks, and undergo 4 blinded neuropsychiatric assessments at baseline, 3, 6, and 24 weeks. Parents will receive weekly interventions of either positive psychoeducation or group process, for 6 weeks and undergo baseline, 3, 6- and 24-weeks neuropsychiatric assessment. Vascular function, inflammatory biomarkers including CRP, homocysteine, and stress involved gene expression biomarkers (i.e. changes in gene expression of FKBP5, DDX6, B2M, LAIR1, RTN4, NUB1, and a multi-gene Conserved Transcriptional Response to Adversity score (CTRA) will be measured at baseline and 6-week. The primary and secondary endpoints are a) changes in PTSD core and reactivity to trauma reminder severity score in response to RFPP intervention, b) changes in wellbeing, biopsychosocial trait, vascular function, neuroinflammation and gene expression biomarkers in response to RFPP, and c) changes in parents' wellbeing and biopsychosocial trait as well as child-parent interactions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
11 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Boy/Girl with documented PTSD,
  • aged 11- 15 years old,
  • able to read/write in English

排除标准

  • presence of intellectual disabilities,
  • presence of psychotic or self-injurious behavior,
  • presence of seizure disorder,
  • presence of language disorder,
  • presence of eye disorders,
  • presence of other neurodevelopmental disorders,
  • presence of diagnosis of substance use disorder.

结局指标

主要结局

To examine the impact of RFPP intervention on core PTSD symptoms

时间窗: 24 months

There will be a change in core PTSD symptoms (% ranged from 0-100) after 6-week RFPP intervention, compared to control group

次要结局

  • To assess the impact of RFPP on well-being of adolescents with PTSD and their parents(24 months)
  • To examine the impact of RFPP on biologic biomarkers, compared to control group(24 months)

研究者

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

Naser Ahmadi, MD, PhD

Assistant Professor of Psychiatry

University of California, Los Angeles

研究点 (2)

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