NCT06708442

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 2, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 27, 2024

Completed
Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

6 months

First QC Date

November 24, 2024

Last Update Submit

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)

EXPERIMENTAL

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.

Behavioral: School-based CBT interventionBehavioral: Guided Narrative Technique (GNT) Writing

Drawing Group A (DA)

ACTIVE COMPARATOR

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.

Behavioral: School-based CBT interventionBehavioral: Guided Narrative Technique (GNT) drawing

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.

Drawing Group A (DA)Intervention Writing Group A (WA)

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.

Intervention Writing Group A (WA)

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.

Drawing Group A (DA)

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

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

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

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

Locations