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NCT05398900 Clinical Trial

Validity and Reliability of Indonesian Translated Ages and Stages Questionnaires - Third Edition (ASQ-3) as a Screening Tool for Developmental Delay in 1-12 Months Old Children

Child Development Clinical Trial

Official title:
Validity and Reliability of Indonesian Translated Ages and Stages Questionnaires - Third Edition (ASQ-3) as a Screening Tool for Developmental Delay in 1-12 Months Old Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05398900
Other study ID # 0519/UN2.F1/ETIK/PPM.00.02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date September 30, 2018

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

Clinical Trial Summary

This study aimed to provide the validity and reliability of the Indonesian ASQ-3 questionnaires as a screening tool for developmentally delayed children aged less than one year old. This study was divided into 2 phases. The first phase (April-June 2018) included the transcultural adaptation of the ASQ-3 questionnaires for 2 to 12 months age groups from English to Indonesian. The second phase (July- September 2018) included a cross-sectional study of Indonesian ASQ-3 questionnaires for parents/caregivers of children aged 1-12 months, with 35 children in each age group by cluster sampling methods, in 2 district areas in East Jakarta.

Recruitment information / eligibility
Status Completed
Enrollment 245
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 12 Months
Eligibility Inclusion Criteria: - Parents with children aged 1-12 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 Kampung Melayu subdistrict and Cipinang Muara subdistrict, Jatinegara district Jakarta

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 maximum score of 60 per domain. 1 day (Once)
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