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

NCT02991378 | Completed DMC

• 1 other identifier: XH-16-042
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Disorder, Child

Keywords

preschool children; emotional disorders/problems; stress related disorders/problems; early intervention

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• level of emotional and stress related problems

  Six months later after the intervention program completion

• rate of knowledge awareness

  through the intervention and psychoeducation completion, an average of 2 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• excluding severe physical disease and neurological developmental disorders can not be participants

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• Shanghai Changning Mental Health Center: collaborator
• Putuo Maternal and Child Health Care Hospital: collaborator
• Mental Health Center of Shanghai Hongkou District: collaborator
• Jingan Maternal and Child Health Care Hospital: collaborator
• Maternal and Infant Healthy Center of Hongkou District, Shanghai: collaborator

Study Sites (1)

Xinhua Hospital

Shanghai, 200092, China

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jinsong Zhang, PhD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

• Lan Shuai, PhD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 13, 2016
• Study Start: May 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: March 30, 2018
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

CN (1)