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NCT04963621 Clinical Trial

RCT of CESIP for Children With Emotional and Stress Problems

Emotional Stress Clinical Trial

Official title:
Child-Adolescent Emotion and Stress Intervention Program for Children With Emotional and Stress Problems- a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04963621
Other study ID # XH-20-065
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2021
Est. completion date March 31, 2022

Study information
Verified date March 2021
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact Jinsong Zhang
Phone 008613651601596
Email zhangjinsong@xinhuamed.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date March 31, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender All
Age group 72 Months to 155 Months
Eligibility 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).

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Child-Adolescent Emotion and Stress Intervention Program
Intervention programs include Emotion and Stress Intervention for children with emotional and stress problems

Locations
Country Name City State
China Xinhua Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 12 weeks after baseline
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