Telepsychiatry in Children: Diagnostic Evaluation of Autism Spectrum Disorder (TELE-TSA)

Centre Hospitalier St Anne

Status: Enrolling

Conditions: Neurodevelopmental Disorders; Autism Spectrum Disorder (ASD)

Treatments: Diagnostic Test: Remote diagnosys

Study type: Interventional

Funder types: Other

Identifiers

NCT06622395

IDRCB:2021-A02675-36 (Other Identifier)

D21-P021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 137 estimated patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Remote Diagnosis Arm

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Remote diagnosys

In person Arm

No Intervention group

Description:

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.