Lifestyle Changes by the COVID-19 (Coronavirus Disease 2019) Pandemic in Children With Developmental Delays

NCT05770362 — Unknown, 260 participants, Taipei Medical University

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Registry	NCT05770362, acronym COVID-19
Status	Unknown
Study type	Observational
Enrollment	260 (Estimated)
Sponsor	Taipei Medical University (Other)
Conditions	Lifestyle-related Condition, COVID-19 Pandemic, Children With Developmental Delays
Interventions	lifestyle questionnaire (Other)
Dates	start 2023-03-19 (estimated), primary completion 2023-07-19 (estimated), completion 2023-07-19 (estimated), first posted 2023-03-15, last updated 2023-03-16
Locations	1 site in Taiwan

-Summary

To evaluate the lifestyle changes caused by the COVID-19 pandemic in children with developmental delays in Taiwan.

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+Detailed description

Two hundred and sixty children with developmental delays in Shin Kong Wu Ho-Su Memorial Hospital will be included. The lifestyle questionnaire will evaluate the lifestyle changes of children with developmental delays during home isolation and release from home isolation during the COVID-19 pandemic in Taiwan. The parents of children with developmental delays will fill out the questionnaire.

+Arms and interventions

lifestyle questionnaire (Other): The changes in lifestyle by lifestyle questionnaire during and after home isolation

+Outcome measures

Primary outcomes

sleeping quality change by lifestyle questionnaire [during and after home isolation through study completion, an average of 6 months]: Sleep quality changes during and after home isolation during the COVID-19 pandemic by lifestyle questionnaire. The minimum and maximum values range from 1 to 5; higher scores mean a worse outcome.

+Eligibility

Sex: All, ages: 1 Year to 6 Years

Inclusion Criteria:

* children diagnosed with developmental delays

Exclusion Criteria:

* children without developmental delays

+Locations (1)

Facility	City	Country	Status
Shin Kong Wu Ho-Su Memorial Hospital	Taipei	Taiwan

+Investigators

Ru-Lan Hsieh, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital