Clinical trial NCT02991378: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder, Child
Keywords: preschool children
emotional disorders/problems
stress related disorders/problems
early intervention
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Changning Mental Health Center
name: Putuo Maternal and Child Health Care Hospital
name: Mental Health Center of Shanghai Hongkou District
name: Jingan Maternal and Child Health Care Hospital
name: Maternal and Infant Healthy Center of Hongkou District, Shanghai
First posted: 2016-12-13
Enrollment: 800
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: level of children's emotional and stress symptoms
timeFrame: through the intervention completion, an average of 2 months
measure: level of children's positive and negative behaviors
timeFrame: through the intervention completion, an average of 2 months
measure: level of chidlren's stress symptoms
timeFrame: through the intervention completion, an average of 2 months
Secondary outcomes:
measure: level of emotional and stress related problems
timeFrame: Six months later after the intervention program completion
measure: rate of knowledge awareness
timeFrame: through the intervention and psychoeducation completion, an average of 2 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jinsong Zhang, PhD
role: STUDY_DIRECTOR
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Lan Shuai, PhD
role: PRINCIPAL_INVESTIGATOR
References: