<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02991378</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-042</org_study_id>
    <nct_id>NCT02991378</nct_id>
  </id_info>
  <brief_title>Early Intervention Skills for Preschool Children With Emotional and Stress Related Disorders</brief_title>
  <official_title>Early Intervention Skills for Preschool Children With Emotional and Stress Related Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai Changning Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Putuo Maternal and Child Health Care Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mental Health Center of Shanghai Hongkou District</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jingan Maternal and Child Health Care Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Maternal and Infant Healthy Center of Hongkou District, Shanghai</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is about early intervention for preschool children with emotional and stress&#xD;
      related disorders. To develop a set of program that could be used in district hospitals for&#xD;
      early intervention of preschool children with emotional and stress related disorder or&#xD;
      problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study will be including two aspects. The first one is to develop a set&#xD;
      of comprehensive program that including psychoeducation, screening, basic assessment,&#xD;
      diagnosis and basic treatment on the emotional and stress related disorders/problems in&#xD;
      preschool children. This program is easy implemented for the psychiatrists and pediatricians&#xD;
      who work in district primary hospitals. They are not only see patients in hospital but also&#xD;
      responsible for the healthcare education in community and kindergarten. In this project they&#xD;
      will be trained to master the knowledge and skills on early intervention on the emotional and&#xD;
      stress related disorders/problem for preschool children in kindergarten and the basic&#xD;
      treatment skills in clinic. The second aspect is the district primary psychiatrists and&#xD;
      pediatricians provide psychoeducation, screening and training in kindergarten. The teachers&#xD;
      will be trained the program on teaching children the skills on emotional self-regulation and&#xD;
      basic stress coping. It's expected that this program will help the primary psychiatrists and&#xD;
      pediatricians' clinical skills and help them to improve the awareness and skills of&#xD;
      children's emotional and stress related problems/disorder in teachers and parents, improve&#xD;
      children's emotional and stress related problems/disorders.&#xD;
&#xD;
      The comprehensive program will include the attained achievements from our past research (the&#xD;
      screening questionnaires, interview methods, booklets and protocol for teachers and parents,&#xD;
      book and courses for training children on emotional self-regulation and stress coping skills,&#xD;
      a simplified CBT manual for children that the trained psychiatrist could use. Xinhua Hospital&#xD;
      will be leading this project and 5 primary hospitals in 4 districts will be involved in.&#xD;
      These five collaborators hospitals were selected from Shanghai district-level Maternal and&#xD;
      Child Health hospitals and district-level Mental Health Center as a pilot.&#xD;
&#xD;
      The selected pediatricians will be major at development and behavioral area, and&#xD;
      psychiatrists will be preferring children. They will be trained the common emotional and&#xD;
      stress related disorders, screening methods, basic diagnosis skill and basic intervention&#xD;
      techniques. After training, they could provide the preventive intervention in kindergarten&#xD;
      and the basic service in clinic. Five hundred children from four years old to six years old&#xD;
      will be in the early intervention group, and another five hundreds children at the same age&#xD;
      will be in the control group for waiting the intervention. The comparisons of the two groups&#xD;
      will be on the knowledge improvement in teacher and parents, the decrease of the prevalence&#xD;
      of and the level of emotional and stress related disorders/problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">March 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>level of children's emotional and stress symptoms</measure>
    <time_frame>through the intervention completion, an average of 2 months</time_frame>
    <description>children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist</description>
  </primary_outcome>
  <primary_outcome>
    <measure>level of children's positive and negative behaviors</measure>
    <time_frame>through the intervention completion, an average of 2 months</time_frame>
    <description>children's positive and negative behaviors assessed by Short and long questionnaire for young children</description>
  </primary_outcome>
  <primary_outcome>
    <measure>level of chidlren's stress symptoms</measure>
    <time_frame>through the intervention completion, an average of 2 months</time_frame>
    <description>chidlren's stress symptoms assessed by Stress symptom checklist for children</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>level of emotional and stress related problems</measure>
    <time_frame>Six months later after the intervention program completion</time_frame>
    <description>children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of knowledge awareness</measure>
    <time_frame>through the intervention and psychoeducation completion, an average of 2 months</time_frame>
    <description>the knowledge awareness of teacher and parents on children's emotional and stress problems and management</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">800</enrollment>
  <condition>Mental Disorder, Child</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in this group will receive the &quot;Children's emotional and stress coping program&quot; which train the children the emotional self-regulation skills and stress coping skill with a standardized protocol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in this group will not receive the &quot;Children's emotional and stress coping program&quot;.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Children's emotional and stress coping program</intervention_name>
    <description>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.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The early intervention for all the children in kindergartens including all the&#xD;
             children from four to six years old without severe physical disorders and mental&#xD;
             disorders;&#xD;
&#xD;
          -  The children who will get the further intervention in hospital should be diagnosed as&#xD;
             the childhood emotional disorders and stress related disorders according to ICD-10&#xD;
             diagnostic criteria (International Classification of Diseases 10th) or the children&#xD;
             with obvious symptoms but do not fully meet the diagnostic criteria will also be&#xD;
             enrolled into the intervention group. The children who have the symptoms after the&#xD;
             screening and interview in kindergartens will be refered to hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  excluding severe physical disease and neurological developmental disorders can not be&#xD;
             participants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jinsong Zhang, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lan Shuai, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xinhua Hospital</name>
      <address>
        <city>Shanghai</city>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>April 21, 2018</last_update_submitted>
  <last_update_submitted_qc>April 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jinsong Zhang</investigator_full_name>
    <investigator_title>Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare</investigator_title>
  </responsible_party>
  <keyword>preschool children</keyword>
  <keyword>emotional disorders/problems</keyword>
  <keyword>stress related disorders/problems</keyword>
  <keyword>early intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
    <mesh_term>Neurodevelopmental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02991378
org study id: XH-16-042
nct id: NCT02991378
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: level of children's emotional and stress symptoms
time frame: through the intervention completion, an average of 2 months
description: children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist
measure: level of children's positive and negative behaviors
time frame: through the intervention completion, an average of 2 months
description: children's positive and negative behaviors assessed by Short and long questionnaire for young children
measure: level of chidlren's stress symptoms
time frame: through the intervention completion, an average of 2 months
description: chidlren's stress symptoms assessed by Stress symptom checklist for children
measure: level of emotional and stress related problems
time frame: Six months later after the intervention program completion
description: children's emotional and stress symptoms assessed by children's emotional and stress symptom screening checklist
measure: rate of knowledge awareness
time frame: through the intervention and psychoeducation completion, an average of 2 months
description: the knowledge awareness of teacher and parents on children's emotional and stress problems and management
arm group label: Intervention group
arm group type: Experimental
description: 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.
arm group label: Control group
arm group type: No Intervention
description: Subjects in this group will not receive the "Children's emotional and stress coping program".
intervention type: Behavioral
intervention name: Children's emotional and stress coping program
description: 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.
arm group label: Intervention group
criteria: 
gender: All
minimum age: 4 Years
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jinsong Zhang, PhD
role: Study Director
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
last name: Lan Shuai, PhD
role: Principal Investigator
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
investigator full name: Jinsong Zhang
investigator title: Director of Department of Medical Psychology, Department of Developmental Behavioral and Child Healthcare
mesh term: Mental Disorders
mesh term: Neurodevelopmental Disorders
sharing ipd: Undecided