Back to resultsRCT of CESIP for Children With Emotional and Stress Problems
Primary Purpose
Emotional Stress
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Child-Adolescent Emotion and Stress Intervention Program
Sponsored by
About this trial
This is an interventional treatment trial for Emotional Stress focused on measuring emotional stress, intervention, RCT
Eligibility Criteria
Inclusion Criteria:
- The results were positive on the SCARED scale; Age 6 years 0 to 12 years 11 months; Total IQ is above 80 assessed by WPPSI.
Exclusion Criteria:
- Attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and Educational level is lower than junior middle school; Participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).
Sites / Locations
- Xinhua HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
waiting
Arm Description
Child-Adolescent Emotion and Stress Intervention Program
treat as usual
Outcomes
Primary Outcome Measures
Strengths and Difficulties Questionnaire (SDQ) total score
A strengths and difficulties questionnaire (SDQ) tests behavior by asking questions on 25 different positive and negative attributes.
Secondary Outcome Measures
Full Information
NCT ID
NCT04963621
First Posted
July 11, 2021
Last Updated
July 11, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04963621
Brief Title
RCT of CESIP for Children With Emotional and Stress Problems
Official Title
Child-Adolescent Emotion and Stress Intervention Program for Children With Emotional and Stress Problems- a Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To explore the effect of Child-Adolescent Emotion and Stress Intervention Program for children with emotional and stress problems, providing early social psychological intervention for aiming the core impairments of emotional and stress problems.
Detailed Description
80 children with emotional and stress problems will be randomly divided into the intervention group and the waiting group. The waiting group received regular clinical intervention, while the intervention group received 12-week training. The intervention program includes emotional regulation and stress intervention training for children by two therapists, which were carried out in one meeting rooms in Xinhua Hospital. Therapists are psychotherapists with a background in child psychotherapy training. After 12 weeks, the improvement of emotional symptoms was compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Stress
Keywords
emotional stress, intervention, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The evaluator was unaware of the subjects' treatment status
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Child-Adolescent Emotion and Stress Intervention Program
Arm Title
waiting
Arm Type
Active Comparator
Arm Description
treat as usual
Intervention Type
Behavioral
Intervention Name(s)
Child-Adolescent Emotion and Stress Intervention Program
Intervention Description
Intervention programs include Emotion and Stress Intervention for children with emotional and stress problems
Primary Outcome Measure Information:
Title
Strengths and Difficulties Questionnaire (SDQ) total score
Description
A strengths and difficulties questionnaire (SDQ) tests behavior by asking questions on 25 different positive and negative attributes.
Time Frame
12 weeks after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
72 Months
Maximum Age & Unit of Time
155 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The results were positive on the SCARED scale; Age 6 years 0 to 12 years 11 months; Total IQ is above 80 assessed by WPPSI.
Exclusion Criteria:
Attention deficit disorders resulting from organic neurological diseases, extensive developmental disorders, mental retardation, childhood schizophrenia, mood disorders, epilepsy, and other organic diseases or other primary mental disorders; parent or guardian with a serious mental illness, such as schizophrenia, mood disorder (onset), etc., and Educational level is lower than junior middle school; Participants who failed to attend more than 80% of the intervention sessions (at least 9 sessions).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinsong Zhang
Phone
008613651601596
Email
zhangjinsong@xinhuamed.com.cn
Facility Information:
Facility Name
Xinhua Hospital
City
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lan Shuai, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RCT of CESIP for Children With Emotional and Stress Problems
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