UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055259 |
|---|---|
| Receipt number | R000063142 |
| Scientific Title | Effects of a School-based Cognitive Behavior Intervention combined with Guided Narrative Technique on Negative Emotions and Cognitions in Children after COVID-19 Outbreak |
| Date of disclosure of the study information | 2024/09/24 |
| Last modified on | 2024/09/24 11:58:20 |
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Basic information
Public title
Effects of a School-based Cognitive Behavior Intervention combined with Guided Narrative Technique on Negative Emotions and Cognitions in Children after COVID-19 Outbreak
Acronym
Effects of a School-based Cognitive Behavior Intervention combined with Guided Narrative Technique on Negative Emotions and Cognitions in Children after COVID-19 Outbreak
Scientific Title
Effects of a School-based Cognitive Behavior Intervention combined with Guided Narrative Technique on Negative Emotions and Cognitions in Children after COVID-19 Outbreak
Scientific Title:Acronym
Effects of a School-based Cognitive Behavior Intervention combined with Guided Narrative Technique on Negative Emotions and Cognitions in Children after COVID-19 Outbreak
Region
| Asia(except Japan) |
Condition
Condition
There will be two conditions: one intervention group and one control group.
Classification by specialty
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
At the beginning of 2020, the COVID-19 broke out in Wuhan, raging across the country quickly afterwards. As a sudden public health emergency, this epidemic caused some stress reactions (including emotional, cognitive, and behavioral reactions) in children. These stress responses, in moderation, may be beneficial as a response to the challenge. However, excessive, and inappropriate stress responses may damage children's mental health, immune function, and daily function.
School-based CBT intervention is effective in alleviating children and adolescent anxiety. However, the effect last only shortly. Therefore, adding a new intervention component is necessary. Guided Narrative Technique (GNT) is an intervention focusing on narrative coherence and emotional expression. It has writing and drawing versions. The writing version was developed from Expressive Writing and has a significant effect on the improvement of various negative emotions and negative cognitions of traumatized individuals.
In this study, a randomized controlled experiment will be implemented. All participants will take a CBT course first. Then, they will be asked to write or draw about the epidemic or other life events using GNT. The study will explore the impact of CBT course combined with GNT on negative emotions and cognition of children after such a public crisis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Revised Children anxiety and depression scale will be used to measure anxiety and depression at baseline, pre-writing, post-treatment, 3-month follow-up, and 6-month follow-up.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
For the intervention group, first, the guardian of the participant will read the informed consent. After the guardian signs the informed consent, the participant will complete the baseline assessment including demographic information, emotional and cognitive measures. The participant will then receive a group cognitive behavioral intervention for 40 minutes each day in consecutive 3 days. The intervention will take place in school classrooms. Counsellors are one senior undergraduate and one first-year PhD student from the School of Psychological and Cognitive Sciences who have received clinical and counselling training. A senior clinical psychologist will supervise the whole courses. The intervention is based on children's cognitive behavioral therapy, with a self-compiled manual. The three sessions are aimed at improving emotional awareness and management, thoughts recognition, and coping. Each session will be accompanied by the presence of the head teachers.
After completing the group intervention, the participant will be required to complete the GNT writing in accordance with the guidelines, and complete two short mood tests and the post-writing assessment for the following 3 days. Each writing session will last for 20-30 minutes. The writing content of the participants will be collected and saved by the researchers for subsequent analysis.
Interventions/Control_2
For the active control group, the procedures of informed consent, baseline assessments, cognitive behavior group intervention, and follow-up assessments will be the same as those for the WA. After completing the group intervention, the participants in active control group will be required to complete the GNT drawing in accordance with the guidelines and to complete two short mood tests and the post-painting assessments in the following 3 days. Each drawing session will last for 20-30 minutes.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 9 | years-old | <= |
Age-upper limit
| 11 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All participants who consented and whose parents also consented to their participation were eligible for inclusion in the trial.
Key exclusion criteria
As a school-based universal intervention, all students with consent were included in the study.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Yinyin |
| Middle name | |
| Last name | Zang |
Organization
Peking University
Division name
School of Psychological and Cognitive Sciences
Zip code
100091
Address
No.5 Yiheyuan Road, Beijing,China
TEL
0086-10-62751831
Yinyin.Zang@pku.edu.cn
Public contact
Name of contact person
| 1st name | Yinyin |
| Middle name | |
| Last name | Zang |
Organization
Peking University
Division name
School of Psychological and Cognitive Sciences
Zip code
100091
Address
No.5 Yiheyuan Road, Beijing,China
TEL
0086-10-62751831
Homepage URL
Yinyin.Zang@pku.edu.cn
Sponsor or person
Institute
Peking University
Institute
Department
Personal name
Funding Source
Organization
Peking University
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Peking University
Address
No.5 Yiheyuan Road, Beijing, China
Tel
+86-10-62757551
leiwang@pku.edu.cn
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 24 | Day |
Related information
URL releasing protocol
The full summary of the result will be released after publication through pku disk.
Publication of results
Unpublished
Result
URL related to results and publications
The full summary of the result will be released after publication through pku disk.
Number of participants that the trial has enrolled
230
Results
The full summary of the result will be released after publication through pku disk.
Results date posted
| 2024 | Year | 08 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The full summary of the result will be released after publication through pku disk.
Participant flow
The full summary of the result will be released after publication through pku disk.
Adverse events
The full summary of the result will be released after publication through pku disk.
Outcome measures
The full summary of the result will be released after publication through pku disk.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 16 | Day |
Last modified on
| 2024 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063142
