Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622395
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Telepsychiatry in Children Diagnostic Evaluation of Autism Spectrum Disorder
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Telepsychiatry in Children Diagnostic Evaluation of Autism Spectrum Disorder
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TELE-TSA
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None