Arabic Ages and Stages Questionnaire-III

NCT02539251 | Completed DMC

• 1 other identifier: PED.LC.07
• Study Type: observational
• Target: 527
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Development

Keywords

Early Child Development; Ages and Stages Questionnaire _3; Validation

Outcome Measures

Primary Outcomes (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.

  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.

  2 years

Study Arms (1)

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

Interventions

Arabic ASQ -3 BEHAVIORAL

Administration of a developmental questionnaire in Arabic (A-ASQ-3) and validation using BSID-III as a gold standard

Validation of Arabic ASQ-3

Eligibility Criteria

• Age: 4 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut

Beirut, 1107 2020, Lebanon

Location

Related Publications (2)

• 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.

  PMID: 16818591 BACKGROUND

• Beaton 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.

  PMID: 11124735 BACKGROUND

Study Officials

• Lama Charafeddine, MD FAAP

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical Pediatrics Fellowship Program, MD FAAP

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: September 3, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2021
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

LE (1)