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Arabic Ages and Stages Questionnaire-III

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ClinicalTrials.gov Identifier: NCT02539251
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Lama Charafeddine, American University of Beirut Medical Center

Brief 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 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.


Condition or disease Intervention/treatment
Child Development Behavioral: Arabic ASQ -3

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.

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Study Type : Observational
Estimated Enrollment : 575 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Adaptation and Validation of the Ages and Stages Questionnaires -3 (ASQ-3) in Arabic
Study Start Date : September 2015
Actual Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Validation of Arabic ASQ-3
This group of patients will serve as a reference for validation of the Arabic ASQ-3
Behavioral: Arabic ASQ -3
Administration of a developmental questionnaire in Arabic (A-ASQ-3) and validation using BSID-III as a gold standard




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

  • Children with known severe disability
  • Children with chronic condition that might interfere with the developmental testing (blindness, deafness, congenital hypothyroidism, severe mental disability)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539251


Contacts
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Contact: Lama Charafeddine, MD FAAP 009611350000 ext 5874 lc12@aub.edu.lb
Contact: Fatima Nasser, MSc 009611350000 ext 5599 fn23@aub.edu.lb

Locations
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Lebanon
American University of Beirut Recruiting
Beirut, Lebanon, 1107 2020
Contact: Lama Charafeddine, M.D       lc12@aub.edu.lb   
Contact: Durriyah Sinno, M.D       ds03@aub.edu.lb   
Sponsors and Collaborators
American University of Beirut Medical Center
Investigators
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Principal Investigator: Lama Charafeddine, MD FAAP American University of Beirut Medical Center

Publications:
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Responsible Party: Lama Charafeddine, Assistant Professor of Clinical Pediatrics Fellowship Program, MD FAAP, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT02539251    
Other Study ID Numbers: PED.LC.07
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Keywords provided by Lama Charafeddine, American University of Beirut Medical Center:
Early Child Development
Ages and Stages Questionnaire _3
Validation