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Completed

NCT Number: NCT07089108

Arabic NODA Validation Study for Autism Diagnosis in Saudi Arabia

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.

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Key information

Age range

6 month–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince Sultan Military Medical City

Riyadh, Riyadh Region, 11322, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Naturalistic Observation Diagnostic Assessment, NODA

Primary outcomes

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

    Time frame: Within 3 weeks of video submission

    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.

Secondary outcomes

  1. Inter-rater Reliability Between Independent NODA Clinicians

    Time frame: Within 3 weeks of video submission

    Two licensed clinicians will independently review the NODA videos and provide ASD diagnostic determinations. The inter-rater reliability will be evaluated using percent agreement and Cohen's kappa coefficient. Intraclass correlation coefficients (ICC) may be calculated for DSM-5 domain scores across reviewers.

  2. Video Completion Rate

    Time frame: Within 3 weeks of enrollment

    Proportion of families who successfully complete all four Arabic NODA video scenarios using the smartphone application. This feasibility metric will be calculated as the percentage of enrolled families who submit all required video recordings within the specified timeframe.

  3. Time to Video Completion

    Time frame: Within 3 weeks of enrollment

    Duration from study enrollment to successful submission of all four required video scenarios. This will be measured in days and reported as mean, median, and range to assess the practical timeline for completing the Arabic NODA assessment process.

  4. Technical Difficulties Frequency

    Time frame: Within 3 weeks of enrollment

    Number and type of technical challenges encountered during the video recording process. This will include frequency of app-related issues, video quality problems, upload failures, and user support requests. Data will be categorized by difficulty type and severity.

  5. Parent Satisfaction with the Arabic NODA Application

    Time frame: Within 1 week after video submission is completed

    Parents will complete a satisfaction survey using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied) after submitting NODA videos. The survey will assess usability, clarity of instructions, cultural appropriateness, and overall satisfaction with the video-guided diagnostic process. Higher scores indicate better satisfaction.

  6. Clinician Confidence in Diagnostic Decision Based on Arabic NODA Videos

    Time frame: Within 1 week after clinician video review completion

    After reviewing each child's videos, clinicians will rate their confidence in their diagnostic decision on a 5-point scale (1 = extremely low confidence, 5 = extremely high confidence). This outcome evaluates the clinical utility and perceived sufficiency of information provided by the Arabic NODA system. Higher scores indicate greater clinician confidence.

Sponsors and collaborators

Lead sponsor

Prince Sultan Military Medical City

Other

Registry information

Official study title

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

Acronym: NODA-ARSA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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