Child DevelopmentNCT02539251
Arabic Ages and Stages Questionnaire-III
An observational study of Child Development, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Early detection and intervention for developmental delays are crucial in promoting healthy child development, hence the need for formal screening. In the Arabic speaking population developmental screening tools are scarce in the native language and there is a need for such a tool for pediatricians and health care… Read more about this study
- Who is it for?
- Ages 4 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Arabic ASQ -3
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 527 participants
- Where
- 1 siteLebanon
- Study dates
- Sep 2015to Dec 2021
- 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 4 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: For adaptation, 75 parents of eligible children between the ages of 4 months and 3 years will be approached. For validation of A-ASQ-3, 500 Children (100 per age group) from a random sample of day care centers and pediatricians' clinics from across the country will be recruited.
Who may be able to join
- Adaptation:
- Arabic speaking parents of children between the ages of 4 months and 3 years
- Validation:
- Children between 4 months and 3 years of age in chosen day care centers
- Children between 4 months and 3 years of age presenting to their pediatricians offices for well child check up.
Who cannot join
- Children with known severe disability
- Children with chronic condition that might interfere with the developmental testing (blindness, deafness, congenital hypothyroidism, severe mental disability)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Validation of the Ages and Stages Questionnaires -3 (ASQ-3) in Arabic
Early detection and intervention for developmental delays are crucial in promoting healthy child development, hence the need for formal screening. In the Arabic speaking population developmental screening tools are scarce in the native language and there is a need for such a tool for pediatricians and health care workers to use routinely.
This study aims to translate, adapt and validate the newest version of ASQ (ASQ-3) to Arabic (A-ASQ-3) based on the previously published study showing that ASQ-2 was culturally sensitive.
Read more
The previously translated A-ASQ-2 will be revised and updated to match the new ASQ-3, then revised by experts in child development. Questionnaires will be adapted and field-tested on 15 subjects per age group (total of 75). For validity, the revised version will be tested on 500 Lebanese children (100 children per age group) selected from all Lebanese governates.
It is expected to generate a culturally adapted and validated Arabic tool for screening children for any developmental delay up to 3 years of age. This tool once published will be available for use by primary care providers and caregivers in Arabic speaking countries. It may be used to screen children for developmental delay as early as 7 months therefore prompting prevention of further delay by starting early intervention and promoting child development.
Read the detailed description
The Ages and Stages Questionnaires (ASQ) is a developmental screening questionnaire for parents to answer regarding their children's level of growth and development between the ages of 7 months and 3 years. This questionnaire was translated into Arabic in order to adapt it for the Arab speaking culture. For the first phase of this study, aiming to adapt and field-test this translated version, parents of eligible children will be recruited from the AUBMC outpatient clinics (OPD and Private Clinics). Interested parents of eligible children will be invited to a private meeting in private settings where the study will be thoroughly explained. 75 parents (fathers or mothers) will be interviewed and asked to answer the ASQ.
At a later stage, 500 parents will be interviewed and asked to answer the ASQ in order to test its validity. A list of all day care centers in Lebanon will be retrieved from the ministry of public health website and a list of all Lebanese pediatricians will be sought from the both Lebanese Order of Physicians (Beirut and Tripoli). Eligible day cares are the ones with at least 15 children between 7 and 36 months. Eligible physicians are those who are actively seeing patients aged between 7 and 36 months with a patient load of at least 10 per day.
To minimize selection bias and to include different socioeconomic groups, a random sample of eligible day care centers and pediatricians from across the Lebanese governorates (Beirut, Mount Lebanon, South Lebanon, North Lebanon and Beqaa) will be selected.
After obtaining the permission of the selected day care centers and pediatricians, flyers explaining the study and inviting parents to participate will be distributed and posted at those centers. Parents of eligible children who contact us and show interest in participating will be invited for a meeting in private settings. Construct validation will be done using varimax rotation, concurrent validity will be done by correlating ASQ-3 scores with Bayley scale for infant development scores. Sensitivity and specificity will also be tested.
Parents will be asked some questions regarding their child's growth in order to evaluate several aspects of his/her developmental skills. It takes 10-15 minutes to complete the questionnaires. After completing the questionnaire, the child's developmental status will be evaluated and any risk of delay will be detected.
- Conditions
- Child Development
- Being tested
- Arabic ASQ -3
- Keywords
- Early Child Development, Ages and Stages Questionnaire _3, Validation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabic ASQ -3Behavioural
Administration of a developmental questionnaire in Arabic (A-ASQ-3) and validation using BSID-III as a gold standard
| Study group | Role | What they receive |
|---|---|---|
| Validation of Arabic ASQ-3 | This group of patients will serve as a reference for validation of the Arabic ASQ-3 Receives: Behavioral: Arabic ASQ -3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adapt and validate Arabic ASQ by measuring construct validity (varimax rotation), concurrent validity by correlating ASQ-3 scores with BSID-III scores and computing sensitivity and specificity taking BSID-III as gold standard.
After cultural adaptation, Arabic ASQ-3 will be validated by measuring construct validity using varimax rotation, concurrent validity by correlating ASQ-3 scores with Bayley scale for infant development scores and by computing the Arabic ASQ-3 sensitivity and specificity taking BSID-III as gold standard.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lama Charafeddine, American University of Beirut Medical Center
- Investigators
- Lama Charafeddine, MD FAAP, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539251
- Sponsor's protocol ID
- PED.LC.07
- Status last verified
- Feb 2022
- First submitted
- 25 Aug 2015
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Council on Children With Disabilities; Section on Developmental Behavioral Pediatrics; Bright Futures Steering Committee; Medical Home Initiatives for Children With Special Needs Project Advisory Committee. Identifying infants and young children with developmental disorders in the medical home: an algorithm for developmental surveillance and screening. Pediatrics. 2006 Jul;118(1):405-20. doi: 10.1542/peds.2006-1231.
PubMed 16818591Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
PubMed 11124735
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Validation of the Ages and Stages Questionnaires -3 (ASQ-3) in Arabic
- ClinicalTrials.gov ID
- NCT02539251
- Acronym / sponsor ID
- PED.LC.07
- Conditions
- Child Development
- Keywords
- Early Child Development, Ages and Stages Questionnaire _3, Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 3 Sep 2015 (estimated)
- 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.
Early detection and intervention for developmental delays are crucial in promoting healthy child development, hence the need for formal screening. In the Arabic speaking population developmental screening tools are scarce in the native language and there is a need for such a tool for pediatricians and health care workers to use routinely.
This study aims to translate, adapt and validate the newest version of ASQ (ASQ-3) to Arabic (A-ASQ-3) based on the previously published study showing that ASQ-2 was culturally sensitive.
The previously translated A-ASQ-2 will be revised and updated to match the new ASQ-3, then revised by experts in child development. Questionnaires will be adapted and field-tested on 15 subjects per age group (total of 75). For validity, the revised version will be tested on 500 Lebanese children (100 children per age group) selected from all Lebanese governates.
It is expected to generate a culturally adapted and validated Arabic tool for screening children for any developmental delay up to 3 years of age. This tool once published will be available for use by primary care providers and caregivers in Arabic speaking countries. It may be used to screen children for developmental delay as early as 7 months therefore prompting prevention of further delay by starting early intervention and promoting child development.
Detailed description
The Ages and Stages Questionnaires (ASQ) is a developmental screening questionnaire for parents to answer regarding their children's level of growth and development between the ages of 7 months and 3 years. This questionnaire was translated into Arabic in order to adapt it for the Arab speaking culture. For the first phase of this study, aiming to adapt and field-test this translated version, parents of eligible children will be recruited from the AUBMC outpatient clinics (OPD and Private Clinics). Interested parents of eligible children will be invited to a private meeting in private settings where the study will be thoroughly explained. 75 parents (fathers or mothers) will be interviewed and asked to answer the ASQ.
At a later stage, 500 parents will be interviewed and asked to answer the ASQ in order to test its validity. A list of all day care centers in Lebanon will be retrieved from the ministry of public health website and a list of all Lebanese pediatricians will be sought from the both Lebanese Order of Physicians (Beirut and Tripoli). Eligible day cares are the ones with at least 15 children between 7 and 36 months. Eligible physicians are those who are actively seeing patients aged between 7 and 36 months with a patient load of at least 10 per day.
To minimize selection bias and to include different socioeconomic groups, a random sample of eligible day care centers and pediatricians from across the Lebanese governorates (Beirut, Mount Lebanon, South Lebanon, North Lebanon and Beqaa) will be selected.
After obtaining the permission of the selected day care centers and pediatricians, flyers explaining the study and inviting parents to participate will be distributed and posted at those centers. Parents of eligible children who contact us and show interest in participating will be invited for a meeting in private settings. Construct validation will be done using varimax rotation, concurrent validity will be done by correlating ASQ-3 scores with Bayley scale for infant development scores. Sensitivity and specificity will also be tested.
Parents will be asked some questions regarding their child's growth in order to evaluate several aspects of his/her developmental skills. It takes 10-15 minutes to complete the questionnaires. After completing the questionnaire, the child's developmental status will be evaluated and any risk of delay will be detected.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation of Arabic ASQ-3 | – | Behavioral: Arabic ASQ -3This group of patients will serve as a reference for validation of the Arabic ASQ-3 |
Who may qualify
- Ages
- 4 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- For adaptation, 75 parents of eligible children between the ages of 4 months and 3 years will be approached. For validation of A-ASQ-3, 500 Children (100 per age group) from a random sample of day care centers and pediatricians' clinics from across the country will be recruited.
Key inclusion criteria (5 listed)
- Arabic speaking parents of children between the ages of 4 months and 3 years
- Children between 4 months and 3 years of age in chosen day care centers
- Children between 4 months and 3 years of age presenting to their pediatricians offices for well child check up.
Key exclusion criteria (2 listed)
- Children with known severe disability
- Children with chronic condition that might interfere with the developmental testing (blindness, deafness, congenital hypothyroidism, severe mental disability)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arabic ASQ -3Administration of a developmental questionnaire in Arabic (A-ASQ-3) and validation using BSID-III as a gold standard | Behavioural | Validation of Arabic ASQ-3 |
Primary outcome
Adapt and validate Arabic ASQ by measuring construct validity (varimax rotation), concurrent validity by correlating ASQ-3 scores with BSID-III scores and computing sensitivity and specificity taking BSID-III as gold standard.
Time frame: 2 years
After cultural adaptation, Arabic ASQ-3 will be validated by measuring construct validity using varimax rotation, concurrent validity by correlating ASQ-3 scores with Bayley scale for infant development scores and by computing the Arabic ASQ-3 sensitivity and specificity taking BSID-III as gold standard.
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 17 Feb 2022.
- Background: PubMed 16818591Council on Children With Disabilities; Section on Developmental Behavioral Pediatrics; Bright Futures Steering Committee; Medical Home Initiatives for Children With Special Needs Project Advisory Committee. Identifying infants and young children with developmental disorders in the medical home: an algorithm for developmental surveillance and screening. Pediatrics. 2006 Jul;118(1):405-20. doi: 10.1542/peds.2006-1231.
- Background: PubMed 11124735Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
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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.
Lama Charafeddine, MD FAAP principal investigator
American University of Beirut Medical Center
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 Child Development, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 5 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 17 Feb 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 Lebanon. 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?
Adapt and validate Arabic ASQ by measuring construct validity (varimax rotation), concurrent validity by correlating ASQ-3 scores with BSID-III scores and computing sensitivity and specificity taking BSID-III as gold standard. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02539251, which also lists 2 linked publications.
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 17 Feb 2022.