Developmental DelayNCT05398900
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
An observational study of Developmental Delay and Child Development, run by Universitas Indonesia at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Developmental Delay, Child Development, Child Development Disorder
- How many people
- 245 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2018to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Parents with children aged 1-12 months living in East Jakarta
Who may be able to join
- Parents with children aged 1-12 months
- Parents who finished at least elementary school
Who cannot join
- Parents with communication difficulties
- Parents who could not speak Indonesian language
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Kampung Melayu subdistrict and Cipinang Muara subdistrict, Jatinegara district
Jakarta
About this study
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.
- Conditions
- Developmental Delay, Child Development, Child Development Disorder, Global Developmental Delay, Infant Development, Motor Delay
- Keywords
- Developmental delay, developmental screening, Indonesian ASQ-3 questionnaire, validity, reliability
- Medical subject headings
- Learning Disabilities, Developmental Disabilities, Psychomotor Disorders, Language Development Disorders, Communication Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Child development
Measured once with Indonesian Ages and Stages-3 questionnaire (cross sectional study) with maximum score of 60 per domain.
Measured: 1 day (Once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start1 Apr 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Hartono Gunardi, MD, PhD, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398900
- Sponsor's protocol ID
- 0519/UN2.F1/ETIK/PPM.00.02
- Status last verified
- May 2022
- First submitted
- 25 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05398900
- Acronym / sponsor ID
- 0519/UN2.F1/ETIK/PPM.00.02
- Conditions
- Developmental Delay, Child Development, Child Development Disorder, Global Developmental Delay, Infant Development, Motor Delay
- Keywords
- Developmental delay, developmental screening, Indonesian ASQ-3 questionnaire, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Parents with children aged 1-12 months living in East Jakarta
Key inclusion criteria (2 listed)
- Parents with children aged 1-12 months
- Parents who finished at least elementary school
Key exclusion criteria (2 listed)
- Parents with communication difficulties
- Parents who could not speak Indonesian language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Delay and Child Development, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child development (time frame: 1 day (Once)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.