Characterizing ASD Adult Population Asking for a Diagnosis

Autism Spectrum Disorder Clinical Trial

— ASSORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147988
• Other study ID #: 2019-A01130-57
• Status: Completed
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: January 2022
• Source: Hôpital le Vinatier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 30, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder

Intervention

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

Locations

Country	Name	City	State
France	Centre hospitalier Le Vinatier	Bron	Aura

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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