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

NCT ID: NCT02991378

Last Updated: 2018-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-03-30

Brief Summary

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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

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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.

Conditions

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Mental Disorder, Child

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Children's emotional and stress coping program

Intervention Type BEHAVIORAL

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shanghai Changning Mental Health Center

UNKNOWN

Sponsor Role collaborator

Putuo Maternal and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Mental Health Center of Shanghai Hongkou District

UNKNOWN

Sponsor Role collaborator

Jingan Maternal and Child Health Care Hospital

UNKNOWN

Sponsor Role collaborator

Maternal and Infant Healthy Center of Hongkou District, Shanghai

UNKNOWN

Sponsor Role collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jinsong Zhang

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jinsong Zhang, PhD

Role: STUDY_DIRECTOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Lan Shuai, PhD

Role: PRINCIPAL_INVESTIGATOR

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Xinhua Hospital

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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XH-16-042

Identifier Type: -

Identifier Source: org_study_id

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