Guided Narrative Technique After Coronavirus Outbreak Influencing Positive and Negative Emotions and Cognition for Children--A Randomized Controlled Trial
1 other identifier
interventional
220
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 11, 2021
CompletedFirst Submitted
Initial submission to the registry
November 24, 2024
CompletedFirst Posted
Study publicly available on registry
November 27, 2024
CompletedNovember 27, 2024
November 1, 2024
6 months
November 24, 2024
November 24, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Anxiety and depression
Child anxiety and depression symptoms measured by RCADS-25.
From enrollment to the 6-month follow-up
Secondary Outcomes (1)
PTSD for children
From enrollment to the 6-month follow-up
Other Outcomes (1)
Emotion awareness
From enrollment to the 6-month follow-up
Study Arms (2)
Intervention Writing Group A (WA)
EXPERIMENTALFirst, 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.
Drawing Group A (DA)
ACTIVE COMPARATORFor 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- have the ability to read and write in Chinese
You may not qualify if:
- no parental consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2024
First Posted
November 27, 2024
Study Start
December 2, 2020
Primary Completion
June 11, 2021
Study Completion
June 11, 2021
Last Updated
November 27, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share