Guided Narrative Technique After Coronavirus Outbreak Influencing Positive and Negative Emotions and Cognition for Children--A Randomized Controlled Trial

November 24, 2024 updated by: Peking University

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

Study Type

Interventional

Enrollment (Actual)

220

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 Locations

      • Beijing, China
        • Peking University

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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • have the ability to read and write in Chinese

Exclusion Criteria:

  • no parental consent

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.
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.

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
Child anxiety and depression symptoms measured by RCADS-25.
From enrollment to the 6-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the 6-month follow-up

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.
From enrollment to the 6-month follow-up

Collaborators and Investigators

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

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)

December 2, 2020

Primary Completion (Actual)

June 11, 2021

Study Completion (Actual)

June 11, 2021

Study Registration Dates

First Submitted

November 24, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

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

product manufactured in and exported from the U.S.

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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