Coping BehaviorNCT05435469
The Changes of Coping With Stressful Events Among Adolescents Under the COVID-19 Pandemic.
An observational study of Coping Behavior and Mental Health Issue, run by Wei XIA, PhD at 1 site in China.
Trial summary
This study aims to describe the changes in coping strategies used by adolescents for stressful life events under the background of epidemic normalization; and explore the causes of coping strategy changes of stressful life events under the background of normalization of the epidemic situation among adolescents. Read more about this study
- Who is it for?
- Ages 14 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Coping Behavior, Mental Health Issue
- What is being tested?
- Questionnaires
- How many people
- 4,300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Dec 2022
- Phase
- Observational
- 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 14 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: General adolescents
Who may be able to join
- Aged 14-25
- Chinese nationality, who has lived in China since the outbreak of the COVID-19 epidemic, and has experienced or is experiencing the epidemic and its normalization.
- Have the normal cognitive ability, expression ability, and social participation ability.
Who cannot join
- Be diagnosed with psychological or mental illness.
- Incapacitated or unable to provide informed consent.
- Patients with severe diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Changes of Coping Strategies With Stressful Events and Mental Health Level Among Adolescents Before and After COVID-19 Pandemic.
This study aims to describe the changes in coping strategies used by adolescents for stressful life events under the background of epidemic normalization; and explore the causes of coping strategy changes of stressful life events under the background of normalization of the epidemic situation among adolescents.
Read the detailed description
Under the special background of normalization of the epidemic situation, this paper describes and discusses the subjective feelings, changes in coping strategies, and causes of adolescent stressful life events, and puts forward a coping mechanism model of stressful adolescent events, which reflects the psychological changes of adolescent groups in the era of the epidemic situation and provides the basis for subsequent intervention measures.
- Conditions
- Coping Behavior, Mental Health Issue
- Being tested
- Questionnaires
- Keywords
- adolescent, pandemic, coping behavior, mental health, stressful life event
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Participants will be asked to respond to the demographic information sheet, Adolescent Self-Rating Life Events Check List, Coping Inventory For Stressful Situations, Social Skills Rating System, brief-symptom-inventory, and Wong and Law EI Scale.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaires assessed adolescents | ① Teenagers aged 14-25. ② Chinese nationality, who has lived in China since the outbreak of the COVID-19 epidemic, and has experienced or is experiencing the epidemic and its normalization. ③ Have the normal cognitive ability, expression ability, and social participation ability. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coping strategies used after the pandemic
The Coping strategies used by the adolescents for the stressful life events after the COVID-19 pandemic will be measured by Coping Inventory For Stressful Situations with the 21-items.
Measured: Baseline
Coping strategies used before the pandemic
The Coping strategies used by the adolescents for the stressful life events before the COVID-19 pandemic will be measured by Coping Inventory For Stressful Situations with the 21-items.
Measured: Baseline
Mental health
The mental health level of the adolescents will be measured by brief-symptom-inventory with 53-items.
Measured: Baseline
Emotional Intelligence status
The Emotional Intelligence status of the adolescents will be measured by Wong and Law EI Scale with 16-items.
Measured: Baseline
Secondary outcomes (3)
Stressful Life Events after pandemic
The Stressful Life Events experienced by the adolescents after the COVID-19 pandemic will be measured by Adolescent Self-Rating Life Events Check List with the 27-items.
Measured: Baseline
Stressful Life Events before pandemic
The Stressful Life Events experienced by the adolescents before the COVID-19 pandemic will be measured by Adolescent Self-Rating Life Events Check List with the 27-items.
Measured: Baseline
Social support
The social support that the adolescent could approach will be measured by Social Skills Rating System with the 10-items.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Jul 2022
- Primary completion30 Aug 2022
- Study completion31 Dec 2022
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 Coping BehaviorStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 4,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wei XIA, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei XIA, PhD, Sun Yat-sen University
- Investigators
- Wei Xia, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435469
- Sponsor's protocol ID
- L2022SYSU-HL-044
- Status last verified
- May 2023
- First submitted
- 25 Jun 2022
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The non-identified IPD will be shared after the outcomes have been published.
Publications
Ding H, Xu Z, Hu W, Guo Y, Wang C, Li S, Hui Z, Wang J, Peng X, Xia W. Changes of stressful life events, coping strategies and mental health among youths in the pre- and post-coronavirus 2019 pandemic era: A cross-sectional study. Int J Soc Psychiatry. 2023 Dec;69(8):2018-2030. doi: 10.1177/00207640231188321. Epub 2023 Aug 1.
PubMed 37528555
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Changes of Coping Strategies With Stressful Events and Mental Health Level Among Adolescents Before and After COVID-19 Pandemic.
- ClinicalTrials.gov ID
- NCT05435469
- Acronym / sponsor ID
- L2022SYSU-HL-044
- Conditions
- Coping Behavior, Mental Health Issue
- Keywords
- adolescent, pandemic, coping behavior, mental health, stressful life event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,300 participants (actual)
- Lead sponsor
- Wei XIA, PhDUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Jun 2022 (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.
This study aims to describe the changes in coping strategies used by adolescents for stressful life events under the background of epidemic normalization; and explore the causes of coping strategy changes of stressful life events under the background of normalization of the epidemic situation among adolescents.
Detailed description
Under the special background of normalization of the epidemic situation, this paper describes and discusses the subjective feelings, changes in coping strategies, and causes of adolescent stressful life events, and puts forward a coping mechanism model of stressful adolescent events, which reflects the psychological changes of adolescent groups in the era of the epidemic situation and provides the basis for subsequent intervention measures.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaires assessed adolescents | – | Other: Questionnaires① Teenagers aged 14-25. ② Chinese nationality, who has lived in China since the outbreak of the COVID-19 epidemic, and has experienced or is experiencing the epidemic and its normalization. ③ Have the normal cognitive ability, expression ability, and social participation ability. |
Who may qualify
- Ages
- 14 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- General adolescents
Key inclusion criteria (3 listed)
- Aged 14-25
- Chinese nationality, who has lived in China since the outbreak of the COVID-19 epidemic, and has experienced or is experiencing the epidemic and its normalization.
- Have the normal cognitive ability, expression ability, and social participation ability.
Key exclusion criteria (3 listed)
- Be diagnosed with psychological or mental illness.
- Incapacitated or unable to provide informed consent.
- Patients with severe diseases.
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 |
|---|---|---|
| QuestionnairesParticipants will be asked to respond to the demographic information sheet, Adolescent Self-Rating Life Events Check List, Coping Inventory For Stressful Situations, Social Skills Rating System, brief-symptom-inventory, and Wong and Law EI Scale. | Other | Questionnaires assessed adolescents |
Primary outcome
Coping strategies used after the pandemic
Time frame: Baseline
The Coping strategies used by the adolescents for the stressful life events after the COVID-19 pandemic will be measured by Coping Inventory For Stressful Situations with the 21-items.
Coping strategies used before the pandemic
Time frame: Baseline
The Coping strategies used by the adolescents for the stressful life events before the COVID-19 pandemic will be measured by Coping Inventory For Stressful Situations with the 21-items.
Mental health
Time frame: Baseline
The mental health level of the adolescents will be measured by brief-symptom-inventory with 53-items.
Emotional Intelligence status
Time frame: Baseline
The Emotional Intelligence status of the adolescents will be measured by Wong and Law EI Scale with 16-items.
3 secondary outcomes
Stressful Life Events after pandemic
Time frame: Baseline
Stressful Life Events before pandemic
Time frame: Baseline
Social support
Time frame: Baseline
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 23 May 2023.
- Derived from this study: PubMed 37528555Ding H, Xu Z, Hu W, Guo Y, Wang C, Li S, Hui Z, Wang J, Peng X, Xia W. Changes of stressful life events, coping strategies and mental health among youths in the pre- and post-coronavirus 2019 pandemic era: A cross-sectional study. Int J Soc Psychiatry. 2023 Dec;69(8):2018-2030. doi: 10.1177/00207640231188321. Epub 2023 Aug 1.
- Individual participant dataSharing planned: Yes. The non-identified IPD will be shared after the outcomes have been published.
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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.
Wei Xia, PhD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coping Behavior and Mental Health Issue, run by Wei XIA, PhD 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 3 inclusion and 3 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 23 May 2023. 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?
Coping strategies used after the pandemic (time frame: Baseline). The study lists 4 primary outcomes in all. 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 NCT05435469, 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 23 May 2023.