NCT05408351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
Last Updated

June 9, 2022

Status Verified

June 1, 2022

Enrollment Period

2 months

First QC Date

May 25, 2022

Last Update Submit

June 6, 2022

Conditions

Keywords

ASQ-3BSID-IIIchild developmentIndonesiascreening testvalidity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age23 Months - 38 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Parents with children aged 23-38 months living in Central Jakarta.

You may qualify if:

  • Parents with children aged 23 - 38 months
  • Parents who finished at least elementary school

You may not qualify if:

  • Parents with communication difficulties
  • Parents who could not speak Indonesian language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanah Tinggi subdistrict community health centers

Jakarta Pusat, 10430, Indonesia

Location

MeSH Terms

Conditions

Developmental DisabilitiesLearning DisabilitiesPsychomotor DisordersLanguage Development Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsLanguage Disorders

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 25, 2022

First Posted

June 7, 2022

Study Start

November 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

June 9, 2022

Record last verified: 2022-06

Locations