An interventional study of Remote diagnosys in Autism Spectrum Disorder (ASD) and Neurodevelopmental Disorders, sponsored by Centre Hospitalier St Anne. Recruiting at 1 site in France. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2024-10-02.
Sponsored by Centre Hospitalier St Anne · Not applicable, Interventional, and Diagnostic
Among 110 studies in Autism Spectrum Disorder with a site in France — 51 open to participants now, 55 under way, 2 of them phase 3. Autism Spectrum Disorder · France.
Among the 110 studies in Autism Spectrum Disorder with a site in France, this one is the 23rd largest by planned enrollment of the 77 interventional ones, is one of 10 that started in 2022, is one of 58 with no phase, reaches primary completion later than 10 of the 54 other live ones, and was the 87th registered.
1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
This study's planned enrollment of 137 is above the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →51 of the 110 studies in Autism Spectrum Disorder with a site in France are open now, in 10 countries. Each count lists the studies.
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 297 take children under 18; 92 take healthy volunteers.
This study: 2 Years to 5 Years · all sexes · no healthy volunteers.
The full table on the hub →110 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 10 started in 2022.
Median enrollment 70 across the 77 interventional studies, 120 across the 33 observational. Of the 43 that completed or were terminated, 8 (19%) have results posted.
8 of 110 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier St Anne is the lead sponsor of 101 studies on the registry; 55 are open to participants now.
Centre Hospitalier St Anne has 3 studies filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
17 of the studies in Autism Spectrum Disorder with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07655115Phase 3Hospital General Universitario Gregorio MarañonSingle Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th | 2026-12-31 |
| NCT06871696Institut National de la Santé Et de la Recherche Médicale, FranceGenetic of Intellectual Deficiency and Autism Spectrum Disorders (RaDiCo-GenIDA) | 2026-11 |
| NCT05512637University Hospital, MontpellierScreening for Neurodevelopmental Disorders in Siblings of Children With Autism Diagnosed in Tertiary Centers | 2026-11 |
| NCT04638452Centre Hospitalier Charles Perrens, BordeauxEvaluation of Behavioural Psycho & Physiological Responses in People With ASD During a Blood Test in Routine Care Practice | 2026-11-30 |
| NCT05864508University Hospital, ToulouseInterest of Oxytocin as an Adjuvant Treatment of Psycho-educational Measures in Challenging Behaviors in Children With Autism Spectrum Disorders and Moderate to Severe Intellectual Disability: Feasibility and Safety Study. | 2026-12 |
Among the 110 studies in Autism Spectrum Disorder with a site in France, from their registry updates:
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.
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by difficulties in social interaction, communication, and restricted, repetitive behaviors. Early diagnosis is critical for intervention and improving developmental outcomes. The French 2018-2022 Autism Plan emphasizes timely diagnosis to optimize care and reduce long-term impacts. Current tools, including the Autism Diagnostic Observation Schedule (ADOS-2) and the Autism Diagnostic Interview-Revised (ADI-R), are widely used but require in-person assessment. The COVID-19 pandemic has complicated the use of such tools due to mask-wearing and social distancing, limiting effective evaluation.
To address this, the Brief Observation of Symptoms of Autism (BOSA) has been adapted for remote use, offering a new approach to diagnosing ASD in children. This study will implement a teleconsultation model, utilizing BOSA and a shortened version of ADI-R, for children aged 24 months to 5 years with suspected ASD. The BOSA was adapted and translated into French under the approval of its creators and WPS publishing. The study aims to determine whether teleconsultation-based evaluations can achieve similar diagnostic accuracy as in-person assessments.
It is hypothesized that remote diagnosis using BOSA and ADI-R will have an accuracy rate of at least 80% compared to in-person ADOS-2 assessments, across key diagnostic domains such as social interaction, communication, and restrictive behaviors. The teleconsultation process may provide a more accessible, less disruptive diagnostic pathway, especially in situations where in-person evaluations are delayed or impractical.
This study will be one of the first in France and Canada to implement such a remote diagnostic model, addressing a gap in the literature and offering a potential solution to diagnostic delays caused by the pandemic. Concordance between teleconsultation and in-person diagnostic outcomes will be measured to assess the reliability and feasibility of this approach.
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by difficulties in social interaction, communication, and restricted, repetitive behaviors. Early diagnosis is critical for intervention and improving developmental outcomes. The French 2018-2022 Autism Plan emphasizes timely diagnosis to optimize care and reduce long-term impacts. Current tools, including the Autism Diagnostic Observation Schedule (ADOS-2) and the Autism Diagnostic Interview-Revised (ADI-R), are widely used but require in-person assessment. The COVID-19 pandemic has complicated the use of such tools due to mask-wearing and social distancing, limiting effective evaluation.
To address this, the Brief Observation of Symptoms of Autism (BOSA) has been adapted for remote use, offering a new approach to diagnosing ASD in children. This study will implement a teleconsultation model, utilizing BOSA and a shortened version of ADI-R, for children aged 24 months to 5 years with suspected ASD. The BOSA was adapted and translated into French under the approval of its creators and WPS publishing. The study aims to determine whether teleconsultation-based evaluations can achieve similar diagnostic accuracy as in-person assessments.
It is hypothesized that remote diagnosis using BOSA and ADI-R will have an accuracy rate of at least 80% compared to in-person ADOS-2 assessments, across key diagnostic domains such as social interaction, communication, and restrictive behaviors. The teleconsultation process may provide a more accessible, less disruptive diagnostic pathway, especially in situations where in-person evaluations are delayed or impractical.
This study will be one of the first in France and Canada to implement such a remote diagnostic model, addressing a gap in the literature and offering a potential solution to diagnostic delays caused by the pandemic. Concordance between teleconsultation and in-person diagnostic outcomes will be measured to assess the reliability and feasibility of this approach.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Diagnostic Test: Remote diagnosys
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Outcome Measure: Number of participants correctly identified with ASD (sensitivity) and number of participants correctly identified without ASD (specificity) using the remote administration of the ADI-R in comparison to the in-person diagnostic standard.
Time frame: End of study (22 weeks after inclusion for all participants).
Concordance Between In-Person and Remote Autism Diagnostic Interview-Revised (ADI-R) Results"
Outcome Measure: Agreement between in-person and remote Autism Diagnostic Interview-Revised (ADI-R) scores across all four diagnostic domains, measured using Cohen's kappa coefficient.
Time frame: 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"
Outcome Measure: Agreement between remote Brief Observation of Symptoms of Autism (BOSA) and in-person Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) diagnoses, measured using Cohen's kappa coefficient.
Time frame: 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)"
Outcome Measure: Sensitivity (number of participants correctly identified with Autism Spectrum Disorder) and specificity (number of participants correctly identified without Autism Spectrum Disorder) of the Brief Observation of Symptoms of Autism (BOSA) compared to the gold standard Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).
Time frame: End of study (22 weeks after inclusion for all participants).
Plan to share: No
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Started Apr 2022 (actual). Primary completion is estimated for Apr 2026, 48 months after the start.
Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 48 months is above that.
Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
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