Characterizing ASD Adult Population Asking for a Diagnosis

NCT04147988 | Completed

• 1 other identifier: 2019-A01130-57
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim at offering to about 80 patients a diagnostic assessment for Autism Spectrum Disorder (ASD), and at testing the feasibility of this protocol to detect and diagnose ASD in adults without intellectual disability.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• Autism Diagnostic Observation Schedule (ADOS-2)

  Autism Diagnostic Observation Schedule (ADOS-2),Scale of observation for the diagnosis of autism.Interactive semi structured direct observation tool. Four modules adapted according to language and level of development. Module 4 is applicable to a teenager or adult with fluent language (consisting of desquestions and conversation).To evaluate social interactions, communication, play and imagination

  3 months

• Adult Asperger's Assessment (AAA)

  Semi-structured clinical interview, with the patient and an informant, To evaluate social interaction, restricted activities, communication, magination, additional criteria

  3 months

Secondary Outcomes (4)

• Vineland Adaptative Behavior Scale (VABS-2)

  3 months

• Hospital Anxiety and Depression Scale (HADS)

  3 months

• Liebowitz Social Anxiety Scale (LSAS)

  3 months

• Yale-Brown Scale(Y-BOCS)

  3 months

Study Arms (1)

DONALD T list

OTHER

adults on the DONALD T list seeking diagnostic advice on autism spectrum disorder or asperger's syndrome

Other: screening and diagnostic assessment DONALD T unit list

Interventions

screening and diagnostic assessment DONALD T unit list OTHER

Screening and diagnostic assessment of the group of people awaiting assessment, and thus test the feasibility of a screening and diagnosis procedure for autism in adults without intellectual disabilities

DONALD T list

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to be on Donald-T's waiting list
• be at least 18 years old

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre hospitalier Le Vinatier

Bron, AURA, 69678, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• SONIE SANDRINE, MD PH

  Centre Hospitalier le Vinatier (BRON, France)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: adult patients without intellectual disability (IQ\> 70 or college-level equivalent) and being on the waiting list for a diagnosis of ASD at the former Donald-T unit.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 1, 2019
• Study Start: September 27, 2019
• Primary Completion: July 31, 2021
• Study Completion: September 30, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)