NCT06622395|Unknown
Telepsychiatry in Children: Diagnostic Evaluation of Autism Spectrum Disorder
TELE-TSA
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TELE-TSA
Sponsor study identifier
Secondary identifiers
OTHER · GHU Paris
interventional
137
1 country
1
Study Start
April 29, 2022
Actual (reported)Primary Completion
April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder recognized as a major national cause in 2012. The French Autism Plan 2018-2022 emphasizes early diagnosis and intervention for better cognitive and behavioral outcomes. The COVID-19 pandemic complicates the use of the ADOS-2 diagnostic tool due to mask-wearing and distancing requirements. To address this, the Brief Observation Symptoms of Autism (BOSA) has been adapted for remote assessment. The BOSA, translated into French, is recommended alongside the Autism Diagnostic Interview -Revised (ADI-R) for complementary diagnostic algorithms. No similar projects have been undertaken in France or Canada.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 29, 2022
Actual (reported)September 26, 2024
Actual (reported)October 2, 2024
Actual (reported)April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Evaluation of the Validity of Remote Diagnosis for Autism Spectrum Disorder in Children Aged 24 to 60 Months with Neurodevelopmental Disorders. First Test (Remote): Visit 1 - Autism Diagnostic Interview-Revised (ADI-R)
The ADI-R is a structured interview conducted with parents or caregivers to assess children suspected of having Autism Spectrum Disorder (ASD). It focuses on three key areas: language/communication, social interaction, and repetitive/restrictive behaviors. The ADI-R provides a comprehensive evaluation of both current and past behaviors, and is commonly used in both clinical and research settings for diagnosis. Scoring: The ADI-R includes scores in three domains: Communication, Social Interaction, and Restricted/Repetitive Behaviors. Each item is scored on a scale from 0 to 3 or 0 to 9, where higher scores indicate more severe impairment.
Visit 1
Evaluation of the Validity of Remote Diagnosis for Autism Spectrum Disorder in Children Aged 24 to 60 Months with Neurodevelopmental Disorders. Second Test (Remote): Visit 2 - Brief Observation of Symptoms of Autism (BOSA)
The BOSA is a observational tool designed to evaluate behaviors related to Autism Spectrum Disorder (ASD) in children: The BOSA includes scores across multiple domains: Social Affect and Restricted/Repetitive Behaviors. Items are typically scored on a scale from 0 to 3, where higher scores indicate more significant impairment in the observed behavior.
Remote Diagnostic Arm (Teleconsultation): First Teleconsultation (V1): A child psychiatrist or psychologist specializing in ASD conducts the ADI-R (short version) interview with the parents or legal guardian via teleconsultation. The professional will score the items from the algorithm. After the consultation, the professional completes a questionnaire assessing the technical aspects of the remote interview (e.g., video quality, connection stability). Second Teleconsultation (V2): During the BOSA remote assessment, the professional sends the parent/caregiver instructions and a video link. The parent watches the video and follows guidance on how to position themselves and the child for optimal visibility. The parent then carries out the BOSA activities under supervision. The professional observes the child's behavior and provides time guidance. Two questionnaires are completed: one on the technical aspects of the consultation and the second on parent-child interaction.
In-person Arm (as usual) : Visit V0 (In-person ADI-R): The ADI-R interview is conducted in person by a psychiatrist or psychologist. Visit V3 (In-person ADOS-2): A different randomly assigned professional will perform an in-person ADOS-2 evaluation.
Remote Diagnostic Arm (Teleconsultation): First Teleconsultation (V1): A child psychiatrist or psychologist specializing in ASD conducts the ADI-R (short version) interview with the parents or legal guardian via teleconsultation. The professional will score the items from the algorithm. After the consultation, the professional completes a questionnaire assessing the technical aspects of the remote interview (e.g., video quality, connection stability). Second Teleconsultation (V2): During the BOSA remote assessment, the professional sends the parent/caregiver instructions and a video link. The parent watches the video and follows guidance on how to position themselves and the child for optimal visibility. The parent then carries out the BOSA activities under supervision. The professional observes the child's behavior and provides time guidance. Two questionnaires are completed: one on the technical aspects of the consultation and the second on parent-child interaction.
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GHU Paris Psychiatrie et Neurosciences
Paris, 75014, France
First Submitted
September 26, 2024
First Posted
October 2, 2024
Study Start
April 29, 2022
Actual (reported)Visit 2
Standard diagnostic pathway (as usual), with the first visit conducted in person: First Test (in person): Visit 0 - Autism Diagnostic Interview-Revised (ADI-)R
The ADI-R is a structured interview conducted with parents or caregivers to assess children suspected of having Autism Spectrum Disorder (ASD). It focuses on three key areas: language/communication, social interaction, and repetitive/restrictive behaviors. The ADI-R provides a comprehensive evaluation of both current and past behaviors, and is commonly used in both clinical and research settings for diagnosis. Scoring: The ADI-R includes scores in three domains: Communication, Social Interaction, and Restricted/Repetitive Behaviors. Each item is scored on a scale from 0 to 3 or 0 to 9, where higher scores indicate more severe impairment.
Visit 0
Standard diagnostic pathway (as usual), with the second visit conducted in person: Second Test (in person): Visit 3 - Autism Diagnostic Observation Schedule, Second Edition (ADOS-2):
The ADOS-2 assesses two main domains: Social Affect (SA) and Restricted/Repetitive Behaviors (RRB), scored based on behavior frequency and intensity. The study uses three ADOS-2 modules tailored to different developmental and language levels: Module Toddler: For children (12-30 months) with little or no spoken language. Focuses on early social communication. Scores: 0 to 24. Module 1: For children over 31 months with little or no spoken language. Assesses non-verbal communication, play, and social interaction. Scores: 0 to 24. Module 2: For individuals using simple phrases. Focuses on verbal communication, socialization, and repetitive behaviors. Scores: 0 to 24 for SA, 0 to 10 for RRB. The total score combines both domains, with higher scores indicating greater impairment.
Visit 3
The primary objective of the study will be to assess the concordance between the gold standard in-person diagnosis and the remote diagnosis, to determine whether remote evaluations provide reliable diagnostic outcomes.
The evaluation criteria will focus on the level of concordance between the in-person (gold standard) and remote diagnoses, using Cohen's kappa coefficient to measure agreement between the two methods.
End of study (22 weeks after inclusion for all participants).
Sensitivity and Specificity of the Remote Autism Diagnostic Interview-Revised (ADI-R) in Diagnosing Autism Spectrum Disorder (ASD)
End of study (22 weeks after inclusion for all participants).
Concordance Between In-Person and Remote Autism Diagnostic Interview-Revised (ADI-R) Results"
End of study (22 weeks after inclusion for all participants).
Concordance Between Remote Brief Observation of Symptoms of Autism (BOSA) and In-Person Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) Diagnoses"
End of study (22 weeks after inclusion for all participants).
Sensitivity and Specificity of the Brief Observation of Symptoms of Autism (BOSA) Compared to the Gold Standard Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)"
End of study (22 weeks after inclusion for all participants).
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Primary Completion
April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 2, 2024
Record last verified: 2024-09
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