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

Primary Purpose

Mental Disorder, Child

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Children's emotional and stress coping program
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mental Disorder, Child focused on measuring preschool children, emotional disorders/problems, stress related disorders/problems, early intervention

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Sites / Locations

  • Xinhua Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

level of children's emotional and stress symptoms
children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist
level of children's positive and negative behaviors
children's positive and negative behaviors assessed by Short and long questionnaire for young children
level of chidlren's stress symptoms
chidlren's stress symptoms assessed by Stress symptom checklist for children

Secondary Outcome Measures

level of emotional and stress related problems
children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist
rate of knowledge awareness
the knowledge awareness of teacher and parents on children's emotional and stress problems and management

Full Information

First Posted
November 22, 2016
Last Updated
April 21, 2018
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Changning Mental Health Center, Putuo Maternal and Child Health Care Hospital, Mental Health Center of Shanghai Hongkou District, Jingan Maternal and Child Health Care Hospital, Maternal and Infant Healthy Center of Hongkou District, Shanghai
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1. Study Identification

Unique Protocol Identification Number
NCT02991378
Brief Title
Early Intervention Skills for Preschool Children With Emotional and Stress Related Disorders
Official Title
Early Intervention Skills for Preschool Children With Emotional and Stress Related Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
Shanghai Changning Mental Health Center, Putuo Maternal and Child Health Care Hospital, Mental Health Center of Shanghai Hongkou District, Jingan Maternal and Child Health Care Hospital, Maternal and Infant Healthy Center of Hongkou District, Shanghai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorder, Child
Keywords
preschool children, emotional disorders/problems, stress related disorders/problems, early intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Subjects in this group will not receive the "Children's emotional and stress coping program".
Intervention Type
Behavioral
Intervention Name(s)
Children's emotional and stress coping program
Intervention Description
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.
Primary Outcome Measure Information:
Title
level of children's emotional and stress symptoms
Description
children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist
Time Frame
through the intervention completion, an average of 2 months
Title
level of children's positive and negative behaviors
Description
children's positive and negative behaviors assessed by Short and long questionnaire for young children
Time Frame
through the intervention completion, an average of 2 months
Title
level of chidlren's stress symptoms
Description
chidlren's stress symptoms assessed by Stress symptom checklist for children
Time Frame
through the intervention completion, an average of 2 months
Secondary Outcome Measure Information:
Title
level of emotional and stress related problems
Description
children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist
Time Frame
Six months later after the intervention program completion
Title
rate of knowledge awareness
Description
the knowledge awareness of teacher and parents on children's emotional and stress problems and management
Time Frame
through the intervention and psychoeducation completion, an average of 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: excluding severe physical disease and neurological developmental disorders can not be participants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinsong Zhang, PhD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lan Shuai, PhD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
ZIP/Postal Code
200092
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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