跳至主要内容
临床试验/NCT07089108
NCT07089108已完成不适用

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

Prince Sultan Military Medical City1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年6月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
Diagnostic Accuracy of Arabic NODA Compared to Gold-Standard ASD Diagnosis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
6 Months 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)
  • Clinician Confidence in Diagnostic Decision Based on Arabic NODA Videos(Within 1 week after clinician video review completion)

研究者

发起方
Prince Sultan Military Medical City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fahad Alhusain

Research Scientist

Prince Sultan Military Medical City

研究点 (1)

Loading locations...

相似试验

Arabic NODA Validation Study for Autism Diagnosis in... | 临床试验