NCT07089108

Arabic NODA Validation Study for Autism Diagnosis in Saudi Arabia

Validation of an Arabic Adaptation of the Naturalistic Observation Diagnostic Assessment (NODA) for Diagnosing Autism Spectrum Disorder in Saudi Arabia

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Prince Sultan Military Medical City · Academic / Other
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Accepted

Summary

This study aims to validate the Arabic adaptation of the Naturalistic Observation Diagnostic Assessment (NODA), a telehealth tool designed to help diagnose Autism Spectrum Disorder (ASD) in young children. NODA guides parents to record home videos of their child in specific everyday situations, which are then reviewed remotely by trained clinicians. The study will compare the results from NODA video assessments to gold-standard in-person diagnostic evaluations. By testing the accuracy and feasibility of Arabic NODA in Saudi Arabia, this research may help improve access to early ASD diagnosis, especially for families in remote or underserved areas.

Detailed description

This cross-sectional diagnostic validation study evaluates the Arabic adaptation of the Naturalistic Observation Diagnostic Assessment (NODA), a smartphone-based telehealth diagnostic tool for Autism Spectrum Disorder (ASD). The study employs a systematic cultural adaptation methodology including forward translation, expert panel review, back-translation, cognitive interviewing, and pilot testing to ensure cultural appropriateness for Saudi populations. The validation phase involves 200 children (100 with confirmed ASD diagnoses, 100 typically developing controls, ages 6 months to 6 years) recruited from autism centers and pediatric clinics in Riyadh, Saudi Arabia. Caregivers use the Arabic NODA smartphone application to record four standardized behavioral scenarios in their home environment: family mealtime, play with others, play alone, and parent-reported concerns. Two licensed clinicians, blinded to participant diagnostic status, independently review all video submissions through a secure web portal and provide diagnostic determinations based on DSM-5 criteria. Primary analysis compares NODA-based diagnoses to gold-standard clinical evaluations established through comprehensive in-person assessments using standardized tools (ADOS-2, ADI-R). Statistical analysis includes calculation of sensitivity, specificity, predictive values, inter-rater reliability, and receiver operating characteristic curves to establish diagnostic accuracy metrics and assess clinical utility for telehealth ASD diagnosis in Arabic-speaking populations.

Conditions

• Autism Spectrum Disorder (ASD)
• Neurodevelopmental Disorders
• Child Development Disorders, Pervasive

Interventions

Type	Name	Description
BEHAVIORAL	Arabic NODA Video-Based Diagnostic Assessment	NODA (Naturalistic Observation Diagnostic Assessment) is a telehealth-based diagnostic tool for Autism Spectrum Disorder (ASD) that guides caregivers to record structured home videos of their child's behavior using a smartphone app. In this study, a culturally adapted Arabic version of NODA was used to capture four standardized behavioral scenarios, which were later reviewed by licensed clinicians for diagnostic evaluation.

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-08-21
• Completion: 2022-12-04
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

1 site across 1 country: Saudi Arabia