- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05398900
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
May 31, 2022 updated by: Prof. Hartono Gunardi, MD, PhD, Indonesia University
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
245
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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Jakarta, Indonesia
- Kampung Melayu subdistrict and Cipinang Muara subdistrict, Jatinegara district
-
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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 month to 1 year (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Parents with children aged 1-12 months living in East Jakarta
Description
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 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: 1 day (Once)
|
Measured once with Indonesian Ages and Stages-3 questionnaire (cross sectional study) with maximum score of 60 per domain.
|
1 day (Once)
|
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)
April 1, 2018
Primary Completion (Actual)
September 30, 2018
Study Completion (Actual)
September 30, 2018
Study Registration Dates
First Submitted
May 25, 2022
First Submitted That Met QC Criteria
May 31, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Actual)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 31, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0519/UN2.F1/ETIK/PPM.00.02
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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