Arabic NODA Validation Study for Autism Diagnosis in Saudi Arabia

NCT ID: NCT07089108

Last Updated: 2025-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2022-12-04

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

Arabic NODA Video-Based Diagnostic Assessment

Intervention Type: 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.

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.

Arabic NODA Video-Based Diagnostic Assessment

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Naturalistic Observation Diagnostic Assessment; NODA

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Prince Sultan Military Medical City

OTHER

Sponsor Role: lead

Responsible Party

Fahad Alhusain

Research Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prince Sultan Military Medical City

Riyadh, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

PrinceSultanMilitaryMedCity

Identifier Type: -

Identifier Source: org_study_id