CClinicalTrials.gg
Status unknownNCT04963621Updated Jul 15, 2021

RCT of CESIP for Children With Emotional and Stress Problems

An interventional study of Child-Adolescent Emotion and Stress Intervention Program in Emotional Stress, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 72 Months to 155 Months. Per ClinicalTrials.gov, last updated 2021-07-15.

Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2021, registered Jul 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
72 Months to 155 Months
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Emotional Stress

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Keywords

  • emotional stress
  • intervention
  • RCT
03

In context

Stress, Psychological

783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.

This study's planned enrollment of 80 is close to the median of 85 across 632 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
72 Months to 155 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Intervention

    Child-Adolescent Emotion and Stress Intervention Program

    Behavioral: Child-Adolescent Emotion and Stress Intervention Program

  • Active comparator
    waiting

    treat as usual

    Behavioral: Child-Adolescent Emotion and Stress Intervention Program

Interventions

  • BehavioralChild-Adolescent Emotion and Stress Intervention Program

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

06

What researchers measure

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.

    Time frame: 12 weeks after baseline

07

Study locations

1 of 1 sites recruiting
  • Xinhua Hospital
    Shanghai, 200092, China
    • Lan Shuai, Ph.D · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04963621
Lead sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Responsible party
Sponsor
First posted
Jul 15, 2021
Start date
Mar 1, 2021
Primary completion
Dec 1, 2021 (estimated)
Completion
Mar 31, 2022 (estimated)
Last update
Jul 15, 2021

Study contacts

Jinsong Zhang
Contact
zhangjinsong@xinhuamed.com.cn
008613651601596

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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