RCT of CESIP for Children With Emotional and Stress Problems

July 11, 2021 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China, 200092
        • Recruiting
        • Xinhua Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention
Child-Adolescent Emotion and Stress Intervention Program
Behavioral: Child-Adolescent Emotion and Stress Intervention Program
Intervention programs include Emotion and Stress Intervention for children with emotional and stress problems
ACTIVE_COMPARATOR: waiting
treat as usual
Behavioral: Child-Adolescent Emotion and Stress Intervention Program
Intervention programs include Emotion and Stress Intervention for children with emotional and stress problems

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ANTICIPATED)

December 1, 2021

Study Completion (ANTICIPATED)

March 31, 2022

Study Registration Dates

First Submitted

July 11, 2021

First Submitted That Met QC Criteria

July 11, 2021

First Posted (ACTUAL)

July 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-20-065

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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