Validity and Reliability of Indonesian Translated Ages an... | NCT05398900

Studies
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

NCT05398900

Sponsor

Indonesia University

Status

Completed

Last Update Posted

Jun 1, 2022Actual

Enrollment

245Actual

Phase

Not provided

Conditions

Developmental Delay
Child Development
Child Development Disorder
Global Developmental Delay
Infant Development
Motor Delay
Speech Delay
Communication Disorders
Development Delay

Interventions

Not provided

Countries

Indonesia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Sep 30, 2018Actual

Completion Date

Sep 30, 2018Actual

First Submitted Date

May 25, 2022

First Submission Date that Met QC Criteria

May 31, 2022

First Posted Date

Jun 1, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 31, 2022

Last Update Posted Date

Jun 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Conditions Module

Conditions

Developmental Delay
Child Development
Child Development Disorder
Global Developmental Delay
Infant Development
Motor Delay
Speech Delay
Communication Disorders
Development Delay

Keywords

Developmental delay
developmental screening
Indonesian ASQ-3 questionnaire
validity
reliability

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

245Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Child development	Measured once with Indonesian Ages and Stages-3 questionnaire (cross sectional study) with maximum score of 60 per domain.	1 day (Once)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

12 Months

Standard Ages

Child

Study Population

Parents with children aged 1-12 months living in East Jakarta

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kampung Melayu subdistrict and Cipinang Muara subdistrict, Jatinegara district		Jakarta			Indonesia

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D007859	Learning Disabilities
D002658	Developmental Disabilities
D011596	Psychomotor Disorders
D007805	Language Development Disorders
D003147	Communication Disorders

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D007806	Language Disorders