Characterizing ASD Adult Population Asking for a Diagnosis (ASSORT)

Describing, Detecting and Orienting Adults Without Intellectual Disability Asking for an Autism Spectrum Disorder Diagnosis

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: screening and diagnostic assessment DONALD T unit list

Detailed Description

About 80 adults asked for an ASD diagnosis a Donald-T unit, now closed.The investigators will offer to these patients a diagnostic assessment, with questionnaires, ADOS-II, Vineland Adaptative Behavior Scale and psychiatric examination. Patients who will show negative scores at the detecting questionnaires will not be further assessed, except for 10 out of them, who will be drawn by lot. Then the investigators will be able to discuss the feasibility of such a procedure with these tools, as well as to describe the clinical profile of adult people asking for ans ASD diagnosis.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aura
    • Bron, Aura, France, 69678
      • Centre Hospitalier Le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any participant who does not meet the inclusion criteria will not be included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DONALD T list; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vineland Adaptative Behavior Scale (VABS-2)	The Vineland Adaptative Behavior Scale (VABS-2) is designed to measure adaptive behavior of individuals from birth to age 90. The Vineland-II contains 5 domains each with 2-3 subdomains. The main domains are: Communication, Daily Living Skills, Socialization, Motor Skills, and Maladaptive Behavior (optional).	3 months
Hospital Anxiety and Depression Scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) is an instrument for detecting anxiety and depressive disorders. It has 14 listed items from 0 to 3. Seven questions relate to anxiety (total A) and seven others to the depressive dimension (total D), allowing thus obtaining two scores (maximum score of each score = 21).	3 months
Liebowitz Social Anxiety Scale (LSAS)	The Liebowitz Social Anxiety Scale (LSAS) is used to evaluate the intensity of fear and avoidance related to confrontation with social situations. The intensity of anxiety is rated separately from 0 (none) to 3 (severe) and the frequency of avoidance: 0 (never = 0%) to 3 (usual = 67 to 100%). We can use several different scores depending on the dimensions we are interested in (performance vs social interaction or anxiety vs. avoidance). The overall score is also widely used, it ranges from 0 to 144. The French norms are as follows: • 56-65: indicates a moderate social phobia; 66-80: indicates a marked social phobia;; 81-95: indicates a severe social phobia; •> 95: indicates a very severe social phobia.	3 months
Yale-Brown Scale(Y-BOCS)	The rating scale is designed to rate the severity and type of symptoms in patients with obsessive compulsive disorder (OCD). The scale includes 10 items that measure 5 dimensions: duration, discomfort in daily life, anxiety, resistance, degree of control. Each item is rated from 0 (no symptoms) to 4 (extreme symptom). The scale makes it possible to distinguish an obsession score: addition of the 5 items (0 ≤ score ≤ 20) and a compulsion score: addition of the 5 items (0 ≤ score ≤ 20). According to the total score obtained (0 ≤ score ≤ 40), we will distinguish: • 10-18: light OCD causing distress but not necessarily dysfunction; the help of a third person is not claimed; 18-25: distress and disability;; ≥ 30: severe disability requiring outside help.	3 months

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: SONIE SANDRINE, MD PH, Centre Hospitalier le Vinatier (BRON, France)

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 1, 2019

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 2019-A01130-57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No