Autism Spectrum Disorder (ASD)NODA-ARSANCT07089108
Arabic NODA Validation Study for Autism Diagnosis in Saudi Arabia
An observational study of Autism Spectrum Disorder (ASD) and Neurodevelopmental Disorders, run by Prince Sultan Military Medical City at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Neurodevelopmental Disorders, Child Development Disorders, Pervasive
- What is being tested?
- Arabic NODA Video-Based Diagnostic Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Jun 2021to 4 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Prince Sultan Military Medical City
Riyadh, Riyadh Region, 11322
About this study
Official title: Validation of an Arabic Adaptation of the Naturalistic Observation Diagnostic Assessment (NODA) for Diagnosing Autism Spectrum Disorder 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.
Read the 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
- Being tested
- Arabic NODA Video-Based Diagnostic Assessment
- 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
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arabic NODA Video-Based Diagnostic AssessmentBehavioural
Also called Naturalistic Observation Diagnostic Assessment, NODA
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Arabic NODA Video-Based Diagnostic Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 weeks of video submission
Secondary outcomes (6)
Inter-rater Reliability Between Independent NODA Clinicians
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.
Measured: Within 3 weeks of video submission
Video Completion Rate
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.
Measured: Within 3 weeks of enrollment
Time to Video Completion
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.
Measured: Within 3 weeks of enrollment
Technical Difficulties Frequency
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.
Measured: Within 3 weeks of enrollment
Parent Satisfaction with the Arabic NODA Application
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.
Measured: Within 1 week after video submission is completed
Clinician Confidence in Diagnostic Decision Based on Arabic NODA Videos
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.
Measured: Within 1 week after clinician video review completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start30 Jun 2021
- Primary completion21 Aug 2022
- Study completion4 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum Disorder (ASD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prince Sultan Military Medical City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fahad Alhusain, Prince Sultan Military Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07089108
- Sponsor's protocol ID
- PrinceSultanMilitaryMedCity
- Acronym
- NODA-ARSA
- Status last verified
- Feb 2025
- First submitted
- 20 May 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to the sensitive nature of the data, which includes video recordings of young children in home environments. These materials are difficult to fully de-identify and are subject to strict ethical and privacy protections under local regulations and IRB oversight.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an Arabic Adaptation of the Naturalistic Observation Diagnostic Assessment (NODA) for Diagnosing Autism Spectrum Disorder in Saudi Arabia
- ClinicalTrials.gov ID
- NCT07089108
- Acronym / sponsor ID
- NODA-ARSA / PrinceSultanMilitaryMedCity
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Prince Sultan Military Medical CityUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 21 Aug 2022 (actual)
- Study completion
- 4 Dec 2022 (actual)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASD Group | – | Behavioral: Arabic NODA Video-Based Diagnostic AssessmentChildren 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. |
| Typically Developing Group | – | Behavioral: Arabic NODA Video-Based Diagnostic AssessmentChildren 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. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arabic NODA Video-Based Diagnostic AssessmentAlso: Naturalistic Observation Diagnostic Assessment, NODANODA (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. | Behavioural | ASD Group, Typically Developing Group |
Primary outcome
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.
6 secondary outcomes
Inter-rater Reliability Between Independent NODA Clinicians
Time frame: Within 3 weeks of video submission
Video Completion Rate
Time frame: Within 3 weeks of enrollment
Time to Video Completion
Time frame: Within 3 weeks of enrollment
Technical Difficulties Frequency
Time frame: Within 3 weeks of enrollment
Parent Satisfaction with the Arabic NODA Application
Time frame: Within 1 week after video submission is completed
Clinician Confidence in Diagnostic Decision Based on Arabic NODA Videos
Time frame: Within 1 week after clinician video review completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to the sensitive nature of the data, which includes video recordings of young children in home environments. These materials are difficult to fully de-identify and are subject to strict ethical and privacy protections under local regulations and IRB oversight.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autism Spectrum Disorder (ASD) and Neurodevelopmental Disorders, run by Prince Sultan Military Medical City at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy of Arabic NODA Compared to Gold-Standard ASD Diagnosis (time frame: Within 3 weeks of video submission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.