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

March 14, 2023 updated by: Ru-Lan Hsieh, Taipei Medical University
To evaluate the lifestyle changes caused by the COVID-19 pandemic in children with developmental delays in Taiwan.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 111-01
        • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children diagnosed with developmental delays in Shin Kong Wu Ho-Su Memorial Hospital in Taiwan.

Description

Inclusion Criteria:

  • children diagnosed with developmental delays

Exclusion Criteria:

  • children without developmental delays

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleeping quality change by lifestyle questionnaire
Time Frame: 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.
during and after home isolation through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 19, 2023

Primary Completion (Anticipated)

July 19, 2023

Study Completion (Anticipated)

July 19, 2023

Study Registration Dates

First Submitted

March 10, 2023

First Submitted That Met QC Criteria

March 12, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHW-111

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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