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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT05408351
Collaborator
(none)
131
Enrollment
1
Location
2
Actual Duration (Months)
66.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    131 participants
    Observational Model:
    Ecologic or Community
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III
    Actual Study Start Date :
    Nov 1, 2019
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Outcome Measures

    Primary Outcome Measures

    1. Child development [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.

    2. Child development [Day 1]

      Measured once with Bayley Scales Infant Development-III with scores ranging between 40 to 160 per domain. Higher score means better development.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Months to 38 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tanah Tinggi subdistrict community health centers Jakarta Pusat Indonesia 10430

    Sponsors and Collaborators

    • Indonesia University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Prof. Hartono Gunardi, MD, PhD, Professor, Indonesia University
    ClinicalTrials.gov Identifier:
    NCT05408351
    Other Study ID Numbers:
    • 1005/UN2.F1/ETIK/PPM.00.02
    First Posted:
    Jun 7, 2022
    Last Update Posted:
    Jun 9, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Prof. Hartono Gunardi, MD, PhD, Professor, Indonesia University
    ASQ-3
    BSID-III
    child development
    Indonesia
    screening test
    validity
    Additional relevant MeSH terms:
    Language Development Disorders
    Developmental Disabilities

    Study Results

    No Results Posted as of Jun 9, 2022