RCT of CESIP for Children With Emotional and Stress Problems

Not Applicable

• Conditions: Emotional Stress

• Registration Number: NCT04963621
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-01
• Study First Submitted: 2021-07-11
• Study First Submitted QC: 2021-07-11
• Last Update Submitted: 2021-07-11
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15
• Primary Completion: 2021-12-01
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Strengths and Difficulties Questionnaire (SDQ) total score	12 weeks after baseline	A strengths and difficulties questionnaire (SDQ) tests behavior by asking questions on 25 different positive and negative attributes.

Trial Locations

Locations (1)

Xinhua Hospital; 🇨🇳 Shanghai, China