Telepsychiatry in Children: Diagnostic Evaluation of Autism Spectrum Disorder

NCT06622395 | Recruiting

• 2 other identifiers: D21-P021IDRCB:2021-A02675-36
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder (ASD); Neurodevelopmental Disorders

Keywords

Telepsychiatry; Remote Diagnosis; Autism Diagnosis; ADOS-2; BOSA; ADI-R; Teleconsultation; Pediatric ASD Diagnosis

Outcome Measures

Primary Outcomes (5)

• 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.

  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).

Secondary Outcomes (4)

• 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).

Study Arms (2)

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.

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.

Interventions

Remote diagnosys DIAGNOSTIC_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.

Remote Diagnosis Arm

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris Psychiatrie et Neurosciences

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Mental Disorders

Central Study Contacts

DE GAULMYN Aude phd, PHD

CONTACT

0145654124; A.DEGAULMYN@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 2, 2024
• Study Start: April 29, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)