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临床试验/NCT02991378
NCT02991378已完成不适用

Early Intervention Skills for Preschool Children With Emotional and Stress Related Disorders

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2017年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
800
试验地点
1
主要终点
level of children's emotional and stress symptoms

研究概览

简要总结

This study is about early intervention for preschool children with emotional and stress related disorders. To develop a set of program that could be used in district hospitals for early intervention of preschool children with emotional and stress related disorder or problems.

详细描述

The objective of this study will be including two aspects. The first one is to develop a set of comprehensive program that including psychoeducation, screening, basic assessment, diagnosis and basic treatment on the emotional and stress related disorders/problems in preschool children. This program is easy implemented for the psychiatrists and pediatricians who work in district primary hospitals. They are not only see patients in hospital but also responsible for the healthcare education in community and kindergarten. In this project they will be trained to master the knowledge and skills on early intervention on the emotional and stress related disorders/problem for preschool children in kindergarten and the basic treatment skills in clinic. The second aspect is the district primary psychiatrists and pediatricians provide psychoeducation, screening and training in kindergarten. The teachers will be trained the program on teaching children the skills on emotional self-regulation and basic stress coping. It's expected that this program will help the primary psychiatrists and pediatricians' clinical skills and help them to improve the awareness and skills of children's emotional and stress related problems/disorder in teachers and parents, improve children's emotional and stress related problems/disorders.

The comprehensive program will include the attained achievements from our past research (the screening questionnaires, interview methods, booklets and protocol for teachers and parents, book and courses for training children on emotional self-regulation and stress coping skills, a simplified CBT manual for children that the trained psychiatrist could use. Xinhua Hospital will be leading this project and 5 primary hospitals in 4 districts will be involved in. These five collaborators hospitals were selected from Shanghai district-level Maternal and Child Health hospitals and district-level Mental Health Center as a pilot.

The selected pediatricians will be major at development and behavioral area, and psychiatrists will be preferring children. They will be trained the common emotional and stress related disorders, screening methods, basic diagnosis skill and basic intervention techniques. After training, they could provide the preventive intervention in kindergarten and the basic service in clinic. Five hundred children from four years old to six years old will be in the early intervention group, and another five hundreds children at the same age will be in the control group for waiting the intervention. The comparisons of the two groups will be on the knowledge improvement in teacher and parents, the decrease of the prevalence of and the level of emotional and stress related disorders/problems.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The early intervention for all the children in kindergartens including all the children from four to six years old without severe physical disorders and mental disorders;
  • The children who will get the further intervention in hospital should be diagnosed as the childhood emotional disorders and stress related disorders according to ICD-10 diagnostic criteria (International Classification of Diseases 10th) or the children with obvious symptoms but do not fully meet the diagnostic criteria will also be enrolled into the intervention group. The children who have the symptoms after the screening and interview in kindergartens will be refered to hospital.

排除标准

  • excluding severe physical disease and neurological developmental disorders can not be participants

研究组 & 干预措施

Intervention group

Experimental

Subjects in this group will receive the "Children's emotional and stress coping program" which train the children the emotional self-regulation skills and stress coping skill with a standardized protocol.

干预措施: Children's emotional and stress coping program (Behavioral)

Control group

No Intervention

Subjects in this group will not receive the "Children's emotional and stress coping program".

结局指标

主要结局

level of children's emotional and stress symptoms

时间窗: through the intervention completion, an average of 2 months

children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist

level of children's positive and negative behaviors

时间窗: through the intervention completion, an average of 2 months

children's positive and negative behaviors assessed by Short and long questionnaire for young children

level of chidlren's stress symptoms

时间窗: through the intervention completion, an average of 2 months

chidlren's stress symptoms assessed by Stress symptom checklist for children

次要结局

  • level of emotional and stress related problems(Six months later after the intervention program completion)
  • rate of knowledge awareness(through the intervention and psychoeducation completion, an average of 2 months)

研究者

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

Jinsong Zhang

Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

研究点 (1)

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