- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06708442
Guided Narrative Technique After Coronavirus Outbreak Influencing Positive and Negative Emotions and Cognition for Children--A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Beijing, China
- Peking University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- have the ability to read and write in Chinese
Exclusion Criteria:
- no parental consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Intervention Writing Group A (WA)
First, the guardian of the participant will read the informed consent.
After the guardian signs the informed consent, the participant will complete the demographic, emotional and cognitive pre-assessment.
The participant will then receive a group cognitive behavioral intervention for 40 minutes each day in the following 3 days.
The intervention will take place in school classrooms in a format similar to offline school classes.
The therapists are one senior undergraduate and one first-year PhD student from the School of Psychological and Cognitive Sciences who have received sufficient training.
The intervention based on the theory of children's cognitive behavioral therapy, with a self-compiled manual.
The three sessions are aimed at emotional awareness and management, thoughts recognition, and coping.
Each session will be accompanied by the presence of the head teachers.
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School-based CBT intervention: a 3-day, 40-minute per day cognitive behavioral intervention.
The intervention will take place in a school classroom in a format similar to offline classroom lectures and classroom interactions.
The intervention will lead by one undergraduate student from the School of Psychological and Cognitive Sciences and one first-year doctoral student with training in clinical psychology.
The content of the intervention was based on the theory of cognitive behavioral therapy for children, with a complete self-developed intervention manual, and three interventions targeting emotional awareness and management, thought recognition, and problem coping, respectively.
Guided Narrative Technique (GNT) Writing : GNT writing is an intervention through writing.
It will be conducted once a day for 20-30 minutes for three days.
Subjects will be asked to complete Guided Narrative Writing at a set time each day for three consecutive days, under the guidance and supervision of a school teacher, following guidelines.
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Active Comparator: Drawing Group A (DA)
For DA group, the procedures of informed consent, pre assessments, cognitive behavior group intervention, and follow-up assessments will be the same as those for WA.
After completing the group intervention, the participants in DA will be required to complete the GNT drawing in accordance with the guidelines at a fixed time each day, under the guidance and supervision of the school teachers, 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.
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School-based CBT intervention: a 3-day, 40-minute per day cognitive behavioral intervention.
The intervention will take place in a school classroom in a format similar to offline classroom lectures and classroom interactions.
The intervention will lead by one undergraduate student from the School of Psychological and Cognitive Sciences and one first-year doctoral student with training in clinical psychology.
The content of the intervention was based on the theory of cognitive behavioral therapy for children, with a complete self-developed intervention manual, and three interventions targeting emotional awareness and management, thought recognition, and problem coping, respectively.
Guided Narrative Technique (GNT) Drawing: GNT drawing is an intervention through drawing.
It will be conducted once a day for 20-30 minutes for three days.
Subjects will be asked to complete Guided Narrative Drawing at a set time each day for three consecutive days, under the guidance and supervision of a school teacher, following guidelines.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety and depression
Time Frame: From enrollment to the 6-month follow-up
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Child anxiety and depression symptoms measured by RCADS-25.
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From enrollment to the 6-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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PTSD for children
Time Frame: From enrollment to the 6-month follow-up
|
The Child PTSD Symptom Scale for DSM-5 (CPSS-5) for adolescents and children (scores from 0 to 4, and total scores vary from 0 to 80).
A higher score represents worse PTSD symptoms.
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From enrollment to the 6-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotion awareness
Time Frame: From enrollment to the 6-month follow-up
|
A 30-item Emotion awareness questionnaire measures emotion awareness on a 3-point Likert scale (1 to 3, and total scores vary from 30 to 90).
A higher score represents better emotion awareness.
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From enrollment to the 6-month follow-up
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hubei primary school RCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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