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

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.

Study Overview

• Status: Completed
• Conditions: Mental Disorder, Child
• Intervention / Treatment: Behavioral: Children's emotional and stress coping program

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.

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200092
    • Xinhua hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 6 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of children's emotional and stress symptoms	children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist	through the intervention completion, an average of 2 months
level of children's positive and negative behaviors	children's positive and negative behaviors assessed by Short and long questionnaire for young children	through the intervention completion, an average of 2 months
level of chidlren's stress symptoms	chidlren's stress symptoms assessed by Stress symptom checklist for children	through the intervention completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
level of emotional and stress related problems	children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist	Six months later after the intervention program completion
rate of knowledge awareness	the knowledge awareness of teacher and parents on children's emotional and stress problems and management	through the intervention and psychoeducation completion, an average of 2 months

Collaborators and Investigators

• 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
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: December 12, 2016
• First Posted (Estimate): December 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 21, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: early intervention; preschool children; emotional disorders/problems; stress related disorders/problems
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Mental Disorders; Neurodevelopmental Disorders
• Other Study ID Numbers: XH-16-042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No