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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02991378
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : April 24, 2018
Sponsor:
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
Information provided by (Responsible Party):
Jinsong Zhang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Mental Disorder, Child Behavioral: Children's emotional and stress coping program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Early Intervention Skills for Preschool Children With Emotional and Stress Related Disorders
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health

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".



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02991378


Locations
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China
Xinhua Hospital
Shanghai, China, 200092
Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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
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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
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Responsible Party: Jinsong Zhang, Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02991378    
Other Study ID Numbers: XH-16-042
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jinsong Zhang, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine:
preschool children
emotional disorders/problems
stress related disorders/problems
early intervention
Additional relevant MeSH terms:
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Disease
Mental Disorders
Neurodevelopmental Disorders
Pathologic Processes