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临床试验/DRKS00015875
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Kids2Health Intervention Core – Inducing Healthy Trajectories for Children with ELS - Kids2Health

Charité Universitätsmedizin Berlin0 个研究点目标入组 77 人开始时间: 2019年2月1日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
77

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
3 Years 至 11 Years(—)
性别
All

入选标准

  • 1) for the children of the existing cohort of the Berlin Longitudinal Child Study and for newly recruited children aged 6-11 years with a history of maltreatment: the presence of a psychiatric disorder according to ICD-10 axis 1, as diagnosed by a structured clinical interview with the caregiver; for the new group of children aged 3-5 years: the presence of maltreatment according to the maltreatment classification system with severity scores =2.
  • 2) timely availability for the participation in weekly therapy sessions over the course of 16 weeks;
  • 3) sufficient German language skills
  • 4) caretaker availability for TF-CBT
  • 5) sufficiently stable psychosocial situation
  • 1) presence of PTSD according to ICD-10 (defined by clinical interview) or PTSD or partial PTSD according to DSM-5, defined by the UCLA PTSD Reaction Index. Partial PTSD is defined by the presence of a traumatic event, the presence of 2 out of 4 symptom clusters and the presence of clinically significant distress or impairment in functioning.
  • 2) timely availability for the participation in weekly therapy sessions over the course of 12 weeks;
  • 3) sufficiently stable psychosocial situation
  • 1) exposure to moderate ELS, including child maltreatment as defined by the maltreatment classification system with a severity score =2 or including prolonged separation from a parent, severe life-threatening illness in child, siblings, or parents, war-related trauma, natural disasters, and accidents, as assessed using structured interviews;
  • 2) timely availability for the participation in weekly therapy sessions over the course of 16 weeks;
  • 3) sufficient German language skills
  • 4) caretaker availability for TF-CBT
  • 5) sufficiently stable psychosocial situation

排除标准

  • TP1, TP2 und TP4:
  • 1) child currently in psychotherapy;
  • 2) acute severe psychiatric disorder (e.g., psychosis);
  • 3) acute and severe somatic disorder;
  • 4) acute suicidality;
  • 5) severe or life-threatening self-injuries during the last 6 months;
  • 6) presence of a pervasive developmental disorder (e.g. autism);
  • 7) mental retardation (IQ < 70);
  • 8) further assessment needed due to complexity of symptoms;
  • 9) indication for inpatient treatment or other further care/intervention.

研究者

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