ASSORT: Characterizing ASD Adult Population Asking for a Diagnosis

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Completed
CT.gov ID
NCT04147988
Collaborator
(none)
42
1
1
24.1
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: screening and diagnostic assessment DONALD T unit list
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Describing, Detecting and Orienting Adults Without Intellectual Disability Asking for an Autism Spectrum Disorder Diagnosis
Actual Study Start Date :
Sep 27, 2019
Actual Primary Completion Date :
Jul 31, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Autism Diagnostic Observation Schedule (ADOS-2) [3 months]

    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

  2. Adult Asperger's Assessment (AAA) [3 months]

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

Secondary Outcome Measures

  1. Vineland Adaptative Behavior Scale (VABS-2) [3 months]

    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).

  2. Hospital Anxiety and Depression Scale (HADS) [3 months]

    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. Liebowitz Social Anxiety Scale (LSAS) [3 months]

    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.

  4. Yale-Brown Scale(Y-BOCS) [3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre hospitalier Le Vinatier Bron Aura France 69678

Sponsors and Collaborators

  • Hôpital le Vinatier

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hôpital le Vinatier
ClinicalTrials.gov Identifier:
NCT04147988
Other Study ID Numbers:
  • 2019-A01130-57
First Posted:
Nov 1, 2019
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2022