Autism Spectrum Disorder (ASD)TELE-TSANCT06622395
Telepsychiatry in Children: Diagnostic Evaluation of Autism Spectrum Disorder
A study testing Remote diagnosys in people with Autism Spectrum Disorder (ASD) and Neurodevelopmental Disorders, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism Spectrum Disorder (ASD), Neurodevelopmental Disorders
- What is being tested?
- Remote diagnosys
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- 29 Apr 2022to 30 Apr 2026
- Phase
- Interventional
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 24 months to 5 years whose families request a diagnostic evaluation at the Autism and Related Disorders Research and Diagnostic Center (CREDAT).
- Consent to participate in the research in addition to their planned evaluation at the Autism and Related Disorders Research and Diagnostic Center (CREDAT), including consent collection procedures for minors.
- Sufficient understanding of the French language to complete the short version of the Autism Diagnostic Interview-Revised (ADI-R) and the Brief Observation of Symptoms of Autism (BOSA) assessment.
Who cannot join
- Lack of access to sufficient technology to participate in the protocol (teleconsultation).
- Refusal to participate in the research.
- Confirmed sensory or motor disorders (hearing or vision) that are not compensated (e.g., no glasses or hearing aids).
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GHU Paris Psychiatrie et Neurosciences
Paris, 75014
Catherine DOYEN, MD phD, 0145654124, C.DOYEN@ghu-paris.fr
Aude DE GAULMYN, PhD, 0145654124 ext. 0033, A.DEGAULMYN@ghu-paris.fr
About this study
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.
Read the 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.
- Being tested
- Remote diagnosys
- Keywords
- Telepsychiatry, Remote Diagnosis, Autism Diagnosis, ADOS-2, BOSA, ADI-R, Teleconsultation, Pediatric ASD Diagnosis
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote diagnosysDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Remote Diagnosis Arm | Experimental | 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. Receives: Diagnostic Test: Remote diagnosys |
| In person Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: End of study (22 weeks after inclusion for all participants).
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: End of study (22 weeks after inclusion for all participants).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start29 Apr 2022
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
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.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a prospective, single-center study aimed at testing the validity of the remote diagnostic modality for patients aged 24 months to 5 years with neurodevelopmental disorders (NDD) and suspected Autism Spectrum Disorder (ASD), involving second or third-line professional intervention. The study is designed sequentially in groups using the Fleming model (Group-Sequential Tests for One Proportion in a Fleming Design). The adopted model includes two interim stages.
- Masking
- None (open label)
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622395
- Sponsor's protocol ID
- D21-P021
- Other IDs
- IDRCB:2021-A02675-36
- Acronym
- TELE-TSA
- Status last verified
- Sep 2024
- First submitted
- 26 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telepsychiatry in Children: Diagnostic Evaluation of Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06622395
- Acronym / sponsor ID
- TELE-TSA / D21-P021
- Keywords
- Telepsychiatry, Remote Diagnosis, Autism Diagnosis, ADOS-2, BOSA, ADI-R, Teleconsultation, Pediatric ASD Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 2 Oct 2024 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, single-center study aimed at testing the validity of the remote diagnostic modality for patients aged 24 months to 5 years with neurodevelopmental disorders (NDD) and suspected Autism Spectrum Disorder (ASD), involving second or third-line professional intervention. The study is designed sequentially in groups using the Fleming model (Group-Sequential Tests for One Proportion in a Fleming Design). The adopted model includes two interim stages.
| Arm | Type | Receives |
|---|---|---|
| Remote Diagnosis Arm | Experimental | Diagnostic Test: Remote diagnosysRemote 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 | No intervention | –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. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 24 months to 5 years whose families request a diagnostic evaluation at the Autism and Related Disorders Research and Diagnostic Center (CREDAT).
- Consent to participate in the research in addition to their planned evaluation at the Autism and Related Disorders Research and Diagnostic Center (CREDAT), including consent collection procedures for minors.
- Sufficient understanding of the French language to complete the short version of the Autism Diagnostic Interview-Revised (ADI-R) and the Brief Observation of Symptoms of Autism (BOSA) assessment.
Key exclusion criteria (3 listed)
- Lack of access to sufficient technology to participate in the protocol (teleconsultation).
- Refusal to participate in the research.
- Confirmed sensory or motor disorders (hearing or vision) that are not compensated (e.g., no glasses or hearing aids).
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 |
|---|---|---|
| Remote diagnosysRemote 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 Diagnosis Arm |
Primary outcome
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)
Time frame: Visit 1
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.
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)
Time frame: Visit 2
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.
Standard diagnostic pathway (as usual), with the first visit conducted in person: First Test (in person): Visit 0 - Autism Diagnostic Interview-Revised (ADI-)R
Time frame: Visit 0
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.
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):
Time frame: Visit 3
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.
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.
Time frame: End of study (22 weeks after inclusion for all participants).
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.
4 secondary outcomes
Sensitivity and Specificity of the Remote Autism Diagnostic Interview-Revised (ADI-R) in Diagnosing Autism Spectrum Disorder (ASD)
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"
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"
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)"
Time frame: End of study (22 weeks after inclusion for all participants).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote diagnosys in people with Autism Spectrum Disorder (ASD) and Neurodevelopmental Disorders, run by Centre Hospitalier St Anne at 1 site in France.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Oct 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DE GAULMYN Aude phd, PHD (0145654124 ext. 0033, A.DEGAULMYN@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Visit 1). The study lists 5 primary outcomes in all. 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 2 Oct 2024.