RCT of CESIP for Children With Emotional and Stress Problems

NCT ID: NCT04963621

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2022-03-31

Brief Summary

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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

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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.

Conditions

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Emotional Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The evaluator was unaware of the subjects' treatment status

Study Groups

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Intervention

Child-Adolescent Emotion and Stress Intervention Program

Group Type EXPERIMENTAL

Child-Adolescent Emotion and Stress Intervention Program

Intervention Type BEHAVIORAL

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

waiting

treat as usual

Group Type ACTIVE_COMPARATOR

Child-Adolescent Emotion and Stress Intervention Program

Intervention Type BEHAVIORAL

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

Interventions

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Child-Adolescent Emotion and Stress Intervention Program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).
Minimum Eligible Age

72 Months

Maximum Eligible Age

155 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xinhua Hospital

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jinsong Zhang

Role: CONTACT

008613651601596

Facility Contacts

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Lan Shuai, Ph.D

Role: primary

Other Identifiers

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XH-20-065

Identifier Type: -

Identifier Source: org_study_id

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