Early Intervention Skills for Preschool Children With Emotional and Stress Related Disorders
|ClinicalTrials.gov Identifier: NCT02991378|
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : April 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mental Disorder, Child||Behavioral: Children's emotional and stress coping program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Early Intervention Skills for Preschool Children With Emotional and Stress Related Disorders|
|Actual Study Start Date :||May 1, 2017|
|Actual Primary Completion Date :||December 1, 2017|
|Actual Study Completion Date :||March 30, 2018|
Experimental: Intervention group
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.
Behavioral: Children's emotional and stress coping program
Giving the children lessons about the emotional self-regulation skills and stress coping skills, with the psychoeducation books and lectures for the teachers and parents.
No Intervention: Control group
Subjects in this group will not receive the "Children's emotional and stress coping program".
- level of children's emotional and stress symptoms [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: through the intervention completion, an average of 2 months ]chidlren's stress symptoms assessed by Stress symptom checklist for children
- level of emotional and stress related problems [ Time Frame: Six months later after the intervention program completion ]children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist
- rate of knowledge awareness [ Time Frame: through the intervention and psychoeducation completion, an average of 2 months ]the knowledge awareness of teacher and parents on children's emotional and stress problems and management
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991378
|Shanghai, China, 200092|
|Study Director:||Jinsong Zhang, PhD||Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|
|Principal Investigator:||Lan Shuai, PhD||Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|