RCT of CESIP for Children With Emotional and Stress Problems

NCT04963621 | Unknown DMC

• 1 other identifier: XH-20-065
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Stress

Keywords

emotional stress; intervention; RCT

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

Child-Adolescent Emotion and Stress Intervention Program

Behavioral: Child-Adolescent Emotion and Stress Intervention Program

waiting

ACTIVE COMPARATOR

treat as usual

Behavioral: Child-Adolescent Emotion and Stress Intervention Program

Interventions

Child-Adolescent Emotion and Stress Intervention Program BEHAVIORAL

Intervention programs include Emotion and Stress Intervention for children with emotional and stress problems

Intervention; waiting

Eligibility Criteria

• Age: 72 Months - 155 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital

Shanghai, 200092, China

RECRUITING

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jinsong Zhang

CONTACT

008613651601596; zhangjinsong@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluator was unaware of the subjects' treatment status
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2021
• First Posted: July 15, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: March 31, 2022
• Last Updated: July 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)