Skip to main content
OpenTrials
Completed

NCT Number: NCT02991378

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Xinhua Hospital

Shanghai, 200092, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Children's emotional and stress coping program

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Jingan Maternal and Child Health Care Hospital
  • Maternal and Infant Healthy Center of Hongkou District, Shanghai
  • Mental Health Center of Shanghai Hongkou District
  • Putuo Maternal and Child Health Care Hospital
  • Shanghai Changning Mental Health Center

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Dec 13, 2016
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.