NCT05823831

Brief 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 during the Severe Acute Respiratory Syndrome Corona Virus pandemic, and compare them with age-matched children and their mothers from other occupations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

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

October 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

April 20, 2023

Last Update Submit

April 20, 2023

Conditions

Keywords

ToddlersPandemicHealthcare workersSocioemotional developmentSleep

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (1)

  • Sleep problems of healthcare workers children

    Baseline

Study Arms (2)

Healthcare workers group

Children of healthcare worker mothers were grouped as the Healthcare workers group. Doctors, nurses, and paramedics are considered as healthcare workers.

Diagnostic Test: Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaireDiagnostic Test: Brief Infant Sleep Questionnaire (BISQ) questionnaireDiagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS) questionnaireDiagnostic Test: Brief Symptom Inventory (BSI) questionnaire

Non-healthcare worker group

Children of mothers from other occupations were grouped as Non-healthcare workers group

Diagnostic Test: Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaireDiagnostic Test: Brief Infant Sleep Questionnaire (BISQ) questionnaireDiagnostic Test: Multidimensional Scale of Perceived Social Support (MSPSS) questionnaireDiagnostic Test: Brief Symptom Inventory (BSI) questionnaire

Interventions

Brief Infant-Toddler Social and Emotional Assessment (BITSEA) questionnaire was used to assess children's social-emotional development.

Healthcare workers groupNon-healthcare worker group

A brief Infant Sleep Questionnaire (BISQ) was used to assess children's sleep.

Healthcare workers groupNon-healthcare worker group

A Multidimensional Scale of Perceived Social Support (MSPSS) questionnaire was used to evaluate maternal social support.

Healthcare workers groupNon-healthcare worker group

A brief Symptom Inventory (BSI) questionnaire was used to evaluate psychological distress.

Healthcare workers groupNon-healthcare worker group

Eligibility Criteria

Age6 Months - 36 Months
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All women having children aged between 6 to 36 months of age

You may qualify if:

  • All women having children aged between 6 to 36 months of age,
  • Parental Education above university level,

You may not qualify if:

  • Out of age range,
  • Parental Education below university level
  • Didn't read the informed consent form and tick the mandatory consent box

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, 34899, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 33791478BACKGROUND
  • Halley 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.

    PMID: 33761277BACKGROUND
  • Skokauskas 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.

    PMID: 32683490BACKGROUND
  • Prime 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.

    PMID: 32437181BACKGROUND
  • Zhang 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.

    PMID: 33578622BACKGROUND

Study Officials

  • Mahmut Caner Us, M.D.

    Marmara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

April 20, 2023

First Posted

April 21, 2023

Study Start

October 1, 2020

Primary Completion

March 30, 2021

Study Completion

October 30, 2021

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Locations