NCT05398900

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

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

April 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 25, 2022

Last Update Submit

May 31, 2022

Conditions

Keywords

Developmental delaydevelopmental screeningIndonesian ASQ-3 questionnairevalidityreliability

Outcome Measures

Primary Outcomes (1)

  • Child development

    Measured once with Indonesian Ages and Stages-3 questionnaire (cross sectional study) with maximum score of 60 per domain.

    1 day (Once)

Eligibility Criteria

Age1 Month - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Parents with children aged 1-12 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)

Kampung Melayu subdistrict and Cipinang Muara subdistrict, Jatinegara district

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Learning DisabilitiesDevelopmental DisabilitiesPsychomotor DisordersLanguage Development DisordersCommunication Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersLanguage 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 1, 2022

Study Start

April 1, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations