Anxiety and DepressionNCT06708442
Guided Narrative Technique After Coronavirus Outbreak Influencing Positive and Negative Emotions and Cognition for Children--A Randomized Controlled Trial
A study testing School-based CBT intervention, Guided Narrative Technique (GNT) Writing and Guided Narrative Technique (GNT) drawing in people with Anxiety and Depression, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Depression
- What is being tested?
- School-based CBT intervention, Guided Narrative Technique (GNT) Writing and Guided Narrative Technique (GNT) drawing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 2 Dec 2020to 11 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- have the ability to read and write in Chinese
Who cannot join
- no parental consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anxiety and Depression
- Being tested
- School-based CBT intervention, Guided Narrative Technique (GNT) Writing, Guided Narrative Technique (GNT) drawing
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
School-based CBT interventionBehavioural
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) WritingBehavioural
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) drawingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: School-based CBT intervention; Behavioral: 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. Receives: Behavioral: School-based CBT intervention; Behavioral: Guided Narrative Technique (GNT) drawing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression
Child anxiety and depression symptoms measured by RCADS-25.
Measured: From enrollment to the 6-month follow-up
Secondary outcomes (1)
PTSD for children
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.
Measured: From enrollment to the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start2 Dec 2020
- Primary completion11 Jun 2021
- Study completion11 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety and DepressionStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708442
- Sponsor's protocol ID
- Hubei primary school RCT
- Status last verified
- Nov 2024
- First submitted
- 24 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang Y, Li M, Xu H, He F, Li M, Wang L, Zang Y. Trainee-delivered school-based intervention with guided narrative writing for adolescent anxiety and depression: a cluster randomized controlled trial. BMC Med. 2026 Mar 26;24(1):289. doi: 10.1186/s12916-026-04816-w.
PubMed 41888870
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Narrative Technique After Coronavirus Outbreak Influencing Positive and Negative Emotions and Cognition for Children--A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06708442
- Acronym / sponsor ID
- Hubei primary school RCT
- Conditions
- Anxiety and Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 11 Jun 2021 (actual)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Writing Group A (WA) | Experimental | Behavioral: School-based CBT intervention, Behavioral: Guided Narrative Technique (GNT) WritingFirst, 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 comparator | Behavioral: School-based CBT intervention, Behavioral: Guided Narrative Technique (GNT) drawingFor 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- have the ability to read and write in Chinese
Key exclusion criteria (1 listed)
- no parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| School-based CBT interventionSchool-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. | Behavioural | Drawing Group A (DA), Intervention Writing Group A (WA) |
| Guided Narrative Technique (GNT) WritingGuided 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. | Behavioural | Intervention Writing Group A (WA) |
| Guided Narrative Technique (GNT) drawingGuided 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. | Behavioural | Drawing Group A (DA) |
Primary outcome
Anxiety and depression
Time frame: From enrollment to the 6-month follow-up
Child anxiety and depression symptoms measured by RCADS-25.
1 secondary outcome
PTSD for children
Time frame: From enrollment to the 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Derived from this study: PubMed 41888870Wang Y, Li M, Xu H, He F, Li M, Wang L, Zang Y. Trainee-delivered school-based intervention with guided narrative writing for adolescent anxiety and depression: a cluster randomized controlled trial. BMC Med. 2026 Mar 26;24(1):289. doi: 10.1186/s12916-026-04816-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing School-based CBT intervention, Guided Narrative Technique (GNT) Writing and Guided Narrative Technique (GNT) drawing in people with Anxiety and Depression, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depression (time frame: From enrollment to the 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06708442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.