Arabic NODA Validation Study for Autism Diagnosis in Saudi Arabia

NCT07089108 | Completed

• 1 other identifier: PrinceSultanMilitaryMedCity
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Autism Spectrum Disorder; ASD; Autism Diagnosis; Telehealth; NODA; Naturalistic Observation Diagnostic Assessment; Arabic; Saudi Arabia; Cultural Adaptation; Remote Video Assessment; Early Childhood Development; Diagnostic Accuracy; Neurodevelopmental Disorders; Digital Health; Pediatric Autism

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of Arabic NODA Compared to Gold-Standard ASD Diagnosis

  This outcome will assess the diagnostic accuracy of the Arabic NODA system in identifying Autism Spectrum Disorder (ASD) in children aged 6 months to 6 years. Accuracy will be determined by comparing NODA-based diagnoses to gold-standard clinical diagnoses using DSM-5 criteria and standardized assessments (ADOS-2 and ADI-R). Metrics will include sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall percent agreement.

  Within 3 weeks of video submission

Secondary Outcomes (6)

• Inter-rater Reliability Between Independent NODA Clinicians

  Within 3 weeks of video submission

• Video Completion Rate

  Within 3 weeks of enrollment

• Time to Video Completion

  Within 3 weeks of enrollment

• Technical Difficulties Frequency

  Within 3 weeks of enrollment

• Parent Satisfaction with the Arabic NODA Application

  Within 1 week after video submission is completed

Study Arms (2)

ASD Group

Children aged 6 months to 6 years with a confirmed diagnosis of Autism Spectrum Disorder (ASD) based on DSM-5 criteria and standardized tools (e.g., ADOS-2, ADI-R). Caregivers recorded four structured home videos using the Arabic NODA app to capture social communication and behavior for remote diagnostic evaluation.

Behavioral: Arabic NODA Video-Based Diagnostic Assessment

Typically Developing Group

Children aged 6 months to 6 years with no known developmental, behavioral, or academic concerns and no family history of ASD. Participants were screened using the Arabic SCQ. Caregivers recorded four standardized home video scenarios using the Arabic NODA app for comparative assessment.

Behavioral: Arabic NODA Video-Based Diagnostic Assessment

Interventions

Arabic NODA Video-Based Diagnostic Assessment BEHAVIORAL

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.

Also known as: Naturalistic Observation Diagnostic Assessment, NODA

ASD Group; Typically Developing Group

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 6 months to 6 years, including those with confirmed Autism Spectrum Disorder and typically developing controls. Participants are recruited from clinical autism centers, general pediatric clinics, and community settings in Riyadh, Saudi Arabia.

You may qualify if:

• Age between 6 months and 6 years old
• For ASD group: Confirmed diagnosis of Autism Spectrum Disorder (ASD) based on DSM-5 criteria established through comprehensive clinical evaluation including standardized assessments (ADOS-2, ADI-R)
• For typically developing group: No developmental, behavioral, or academic concerns reported by parents or teachers; negative screening for ASD using Arabic Social Communication Questionnaire (SCQ)
• Parent or primary caregiver fluent in Arabic language
• Access to a smartphone with internet connectivity
• Ability to complete all four NODA video recording scenarios using the Arabic smartphone application

You may not qualify if:

• Significant visual or hearing impairments that would interfere with video-based behavioral assessment
• Major motor impairments that significantly limit the child's ability to interact socially or participate in video recording tasks
• Diagnosed genetic syndromes or neurological conditions unrelated to ASD
• Non-Arabic speaking household
• Inability to complete the required video recording protocol after training and support

Sponsors & Collaborators

• Prince Sultan Military Medical City: lead

Study Sites (1)

Prince Sultan Military Medical City

Riyadh, Riyadh Region, 11322, Saudi Arabia

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders; Child Development Disorders, Pervasive

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: July 28, 2025
• Study Start: June 30, 2021
• Primary Completion: August 21, 2022
• Study Completion: December 4, 2022
• Last Updated: July 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)