Emotional Disorder of ChildhoodNCT05823831
Social-emotional and Behavioural Problems of Healthcare Workers During the Outbreak
An observational study of Emotional Disorder of Childhood, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Healthcare worker mothers had to leave their children with their relatives out the fear of contagion and isolated themselves. The investigators aimed to explore the sleep, socioemotional and behavioural problems of children of healthcare workers; assess the psychological distress of mothers and their social support… Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Emotional Disorder of Childhood
- What is being tested?
- Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire, Brief Infant Sleep Questionnaire (BISQ) questionnaire and Multidimensional Scale of Perceived Social Support (MSPSS) questionnaire
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 30 Oct 2021
- 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 6 to 36 months
- All sexes
- Child
Study population: All women having children aged between 6 to 36 months of age
Who may be able to join
- All women having children aged between 6 to 36 months of age,
- Parental Education above university level,
Who cannot join
- Out of age range,
- Parental Education below university level
- Didn't read the informed consent form and tick the mandatory consent box
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social-emotional and Behavioural Problems of Healthcare Workers' Young Children During the Severe Acute Respiratory Syndrome Corona Virus Outbreak: a Case-control Study
Healthcare worker mothers had to leave their children with their relatives out the fear of contagion and isolated themselves. The investigators aimed to explore the sleep, socioemotional and behavioural problems of children of healthcare workers; assess the psychological distress of mothers and their social support during the Severe Acute Respiratory Syndrome Corona Virus pandemic, and compare them with age-matched children and their mothers from other occupations.
Read the detailed description
Healthcare worker mothers had to leave their children with their relatives out the fear of contagion and isolated themselves. The investigators aimed to explore the sleep, socioemotional and behavioural problems of children of healthcare workers; assess the psychological distress of mothers and their social support during the Severe Acute Respiratory Syndrome Corona Virus pandemic, and compare them with age-matched children and their mothers from other occupations.
A case-control study design was applied, and a snowball approach was used to enrol volunteered participants aged between 6 to 36 months of age, through a Google survey. The investigators used Brief Infant Sleep Questionnaire and the Brief Infant-Toddler Social and Emotional Assessment questionnaire to assess children's sleep and socioemotional and behavioural problems respectively. A Multidimensional Scale of Perceived Social Support and a Brief Symptom Inventory were used to evaluate the social support and psychological distress of mothers.
- Conditions
- Emotional Disorder of Childhood
- Being tested
- Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire, Brief Infant Sleep Questionnaire (BISQ) questionnaire, Multidimensional Scale of Perceived Social Support (MSPSS) questionnaire, Brief Symptom Inventory (BSI) questionnaire
- Keywords
- Toddlers, Pandemic, Healthcare workers, Socioemotional development, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaireDiagnostic test
Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire was used to assess children's social-emotional development.
Brief Infant Sleep Questionnaire (BISQ) questionnaireDiagnostic test
A brief Infant Sleep Questionnaire (BISQ) was used to assess children's sleep.
Multidimensional Scale of Perceived Social Support (MSPSS) questionnaireDiagnostic test
A Multidimensional Scale of Perceived Social Support (MSPSS) questionnaire was used to evaluate maternal social support.
Brief Symptom Inventory (BSI) questionnaireDiagnostic test
A brief Symptom Inventory (BSI) questionnaire was used to evaluate psychological distress.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare workers group | Children of healthcare worker mothers were grouped as the Healthcare workers group. Doctors, nurses, and paramedics are considered as healthcare workers. Receives: Diagnostic Test: Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire; Diagnostic Test: Brief Infant Sleep Questionnaire (BISQ) questionnaire; Diagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS) questionnaire; Diagnostic Test: Brief Symptom Inventory (BSI) questionnaire | |
| Non-healthcare worker group | Children of mothers from other occupations were grouped as Non-healthcare workers group Receives: Diagnostic Test: Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire; Diagnostic Test: Brief Infant Sleep Questionnaire (BISQ) questionnaire; Diagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS) questionnaire; Diagnostic Test: Brief Symptom Inventory (BSI) questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social-emotional and behavioural problems of healthcare workers children
The study was planned based on the hypothesis that children of healthcare workers experienced more socioemotional and behavioural problems than children of mothers from other occupations during the Severe Acute Respiratory Syndrome Corona Virus pandemic. The investigators aimed to explore Social-emotional and behavioural problems of healthcare workers by using Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire, and compare them with age-matched peers and their mothers from other occupations.
Measured: Baseline
Secondary outcomes (1)
Sleep problems of healthcare workers children
The investigators aimed to explore Sleep problems of healthcare workers by using Brief Infant Sleep Questionnaire (BISQ) questionnaire, and compare them with age-matched peers and their mothers from other occupations.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Oct 2020
- Primary completion30 Mar 2021
- Study completion30 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Emotional Disorder of ChildhoodStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mahmut caner us, Marmara University
- Investigators
- Mahmut Caner Us, M.D., Principal investigator, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823831
- Sponsor's protocol ID
- 2020.10.2
- Status last verified
- Apr 2023
- First submitted
- 20 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
Diver S, Buccheri N, Ohri C. The value of healthcare worker support strategies to enhance wellbeing and optimise patient care. Future Healthc J. 2021 Mar;8(1):e60-e66. doi: 10.7861/fhj.2020-0176.
PubMed 33791478Halley MC, Mathews KS, Diamond LC, Linos E, Sarkar U, Mangurian C, Sabry H, Goyal MK, Olazo K, Miller EG, Jagsi R, Linos E. The Intersection of Work and Home Challenges Faced by Physician Mothers During the Coronavirus Disease 2019 Pandemic: A Mixed-Methods Analysis. J Womens Health (Larchmt). 2021 Apr;30(4):514-524. doi: 10.1089/jwh.2020.8964. Epub 2021 Mar 23.
PubMed 33761277Skokauskas N, Leventhal B, Cardeli EL, Belfer M, Kaasboll J, Cohen J. Supporting children of healthcare workers during the COVID-19 pandemic. Eur Child Adolesc Psychiatry. 2022 Jan;31(1):203-204. doi: 10.1007/s00787-020-01604-6. Epub 2020 Jul 18. No abstract available.
PubMed 32683490Prime H, Wade M, Browne DT. Risk and resilience in family well-being during the COVID-19 pandemic. Am Psychol. 2020 Jul-Aug;75(5):631-643. doi: 10.1037/amp0000660. Epub 2020 May 21.
PubMed 32437181Zhang J, Deng X, Liu H, Xu X, Fang R. Evaluation of the mental health status of community healthcare workers during the COVID-19 outbreak. Medicine (Baltimore). 2021 Feb 12;100(6):e24739. doi: 10.1097/MD.0000000000024739.
PubMed 33578622
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social-emotional and Behavioural Problems of Healthcare Workers' Young Children During the Severe Acute Respiratory Syndrome Corona Virus Outbreak: a Case-control Study
- ClinicalTrials.gov ID
- NCT05823831
- Acronym / sponsor ID
- 2020.10.2
- Conditions
- Emotional Disorder of Childhood
- Keywords
- Toddlers, Pandemic, Healthcare workers, Socioemotional development, Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Oct 2021 (actual)
- First posted
- 21 Apr 2023 (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.
Healthcare worker mothers had to leave their children with their relatives out the fear of contagion and isolated themselves. The investigators aimed to explore the sleep, socioemotional and behavioural problems of children of healthcare workers; assess the psychological distress of mothers and their social support during the Severe Acute Respiratory Syndrome Corona Virus pandemic, and compare them with age-matched children and their mothers from other occupations.
Detailed description
Healthcare worker mothers had to leave their children with their relatives out the fear of contagion and isolated themselves. The investigators aimed to explore the sleep, socioemotional and behavioural problems of children of healthcare workers; assess the psychological distress of mothers and their social support during the Severe Acute Respiratory Syndrome Corona Virus pandemic, and compare them with age-matched children and their mothers from other occupations.
A case-control study design was applied, and a snowball approach was used to enrol volunteered participants aged between 6 to 36 months of age, through a Google survey. The investigators used Brief Infant Sleep Questionnaire and the Brief Infant-Toddler Social and Emotional Assessment questionnaire to assess children's sleep and socioemotional and behavioural problems respectively. A Multidimensional Scale of Perceived Social Support and a Brief Symptom Inventory were used to evaluate the social support and psychological distress of mothers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers group | – | Diagnostic Test: Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire, Diagnostic Test: Brief Infant Sleep Questionnaire (BISQ) questionnaire, Diagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS) questionnaire, Diagnostic Test: Brief Symptom Inventory (BSI) questionnaireChildren of healthcare worker mothers were grouped as the Healthcare workers group. Doctors, nurses, and paramedics are considered as healthcare workers. |
| Non-healthcare worker group | – | Diagnostic Test: Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire, Diagnostic Test: Brief Infant Sleep Questionnaire (BISQ) questionnaire, Diagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS) questionnaire, Diagnostic Test: Brief Symptom Inventory (BSI) questionnaireChildren of mothers from other occupations were grouped as Non-healthcare workers group |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Age groups
- Child
- Study population
- All women having children aged between 6 to 36 months of age
Key inclusion criteria (2 listed)
- All women having children aged between 6 to 36 months of age,
- Parental Education above university level,
Key exclusion criteria (3 listed)
- Out of age range,
- Parental Education below university level
- Didn't read the informed consent form and tick the mandatory consent box
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 |
|---|---|---|
| Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaireBrief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire was used to assess children's social-emotional development. | Diagnostic test | Healthcare workers group, Non-healthcare worker group |
| Brief Infant Sleep Questionnaire (BISQ) questionnaireA brief Infant Sleep Questionnaire (BISQ) was used to assess children's sleep. | Diagnostic test | Healthcare workers group, Non-healthcare worker group |
| Multidimensional Scale of Perceived Social Support (MSPSS) questionnaireA Multidimensional Scale of Perceived Social Support (MSPSS) questionnaire was used to evaluate maternal social support. | Diagnostic test | Healthcare workers group, Non-healthcare worker group |
| Brief Symptom Inventory (BSI) questionnaireA brief Symptom Inventory (BSI) questionnaire was used to evaluate psychological distress. | Diagnostic test | Healthcare workers group, Non-healthcare worker group |
Primary outcome
Social-emotional and behavioural problems of healthcare workers children
Time frame: Baseline
The study was planned based on the hypothesis that children of healthcare workers experienced more socioemotional and behavioural problems than children of mothers from other occupations during the Severe Acute Respiratory Syndrome Corona Virus pandemic. The investigators aimed to explore Social-emotional and behavioural problems of healthcare workers by using Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire, and compare them with age-matched peers and their mothers from other occupations.
1 secondary outcome
Sleep problems of healthcare workers children
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 24 Apr 2023.
- Background: PubMed 33791478Diver S, Buccheri N, Ohri C. The value of healthcare worker support strategies to enhance wellbeing and optimise patient care. Future Healthc J. 2021 Mar;8(1):e60-e66. doi: 10.7861/fhj.2020-0176.
- Background: PubMed 33761277Halley MC, Mathews KS, Diamond LC, Linos E, Sarkar U, Mangurian C, Sabry H, Goyal MK, Olazo K, Miller EG, Jagsi R, Linos E. The Intersection of Work and Home Challenges Faced by Physician Mothers During the Coronavirus Disease 2019 Pandemic: A Mixed-Methods Analysis. J Womens Health (Larchmt). 2021 Apr;30(4):514-524. doi: 10.1089/jwh.2020.8964. Epub 2021 Mar 23.
- Background: PubMed 32683490Skokauskas N, Leventhal B, Cardeli EL, Belfer M, Kaasboll J, Cohen J. Supporting children of healthcare workers during the COVID-19 pandemic. Eur Child Adolesc Psychiatry. 2022 Jan;31(1):203-204. doi: 10.1007/s00787-020-01604-6. Epub 2020 Jul 18. No abstract available.
- Background: PubMed 32437181Prime H, Wade M, Browne DT. Risk and resilience in family well-being during the COVID-19 pandemic. Am Psychol. 2020 Jul-Aug;75(5):631-643. doi: 10.1037/amp0000660. Epub 2020 May 21.
- Background: PubMed 33578622Zhang J, Deng X, Liu H, Xu X, Fang R. Evaluation of the mental health status of community healthcare workers during the COVID-19 outbreak. Medicine (Baltimore). 2021 Feb 12;100(6):e24739. doi: 10.1097/MD.0000000000024739.
- Individual participant dataSharing planned: No. The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
Mahmut Caner Us, M.D. principal investigator
Marmara 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 Emotional Disorder of Childhood, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 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 24 Apr 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 Turkey (Türkiye). 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?
Social-emotional and behavioural problems of healthcare workers children (time frame: Baseline). 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 NCT05823831, which also lists 5 linked publications.
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 24 Apr 2023.