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NCT05408351 Clinical Trial

The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III

Child Development Clinical Trial

Official title:
The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05408351
Other study ID # 1005/UN2.F1/ETIK/PPM.00.02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date December 31, 2019

Study information
Verified date June 2022
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 131
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 23 Months to 38 Months
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Indonesia Tanah Tinggi subdistrict community health centers Jakarta Pusat

Sponsors (1)
Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Child development 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
Primary Child development Measured once with Bayley Scales Infant Development-III with scores ranging between 40 to 160 per domain. Higher score means better development. Day 1
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