- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05408351
The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III
June 6, 2022 updated by: Prof. Hartono Gunardi, MD, PhD, Indonesia University
This study aimed to evaluate the concurrent validity information of the 24-, 30-, and 36-month Indonesian ASQ-3 with the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III) in Indonesian children.
Children living in Tanah Tinggi subdistrict, Central Jakarta, were recruited conveniently from November to December 2019.
Children within the 24-, 30-, or 36-month age group were assessed for Indonesian ASQ-3 concurrently with BSID-III as the reference standard according to their age groups.
Screening test accuracy was measured in sensitivity, specificity, and predictive values for both overall dan specific domains.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
131
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Jakarta Pusat, Indonesia, 10430
- Tanah Tinggi subdistrict community health centers
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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 3 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Parents with children aged 23-38 months living in Central Jakarta.
Description
Inclusion Criteria:
- Parents with children aged 23 - 38 months
- Parents who finished at least elementary school
Exclusion Criteria:
- Parents with communication difficulties
- Parents who could not speak Indonesian language
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 |
---|---|---|
Child development
Time Frame: Day 1
|
Measured once with Indonesian Ages and Stages-3 questionnaire (cross sectional study) with scores ranging between 0 to 60 per domain.
Higher score means better development.
|
Day 1
|
Child development
Time Frame: Day 1
|
Measured once with Bayley Scales Infant Development-III with scores ranging between 40 to 160 per domain.
Higher score means better development.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
November 1, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
May 25, 2022
First Submitted That Met QC Criteria
June 2, 2022
First Posted (Actual)
June 7, 2022
Study Record Updates
Last Update Posted (Actual)
June 9, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1005/UN2.F1/ETIK/PPM.00.02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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