Characterizing ASD Adult Population Asking for a Diagnosis (ASSORT)
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
screening and diagnostic assessment DONALD T unit list
Sponsored by
About this trial
This is an interventional diagnostic trial for Autism Spectrum Disorder
Eligibility Criteria
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.
Sites / Locations
- Centre hospitalier Le Vinatier
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
DONALD T list
Arm Description
adults on the DONALD T list seeking diagnostic advice on autism spectrum disorder or asperger's syndrome
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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).
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).
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04147988
Brief Title
Characterizing ASD Adult Population Asking for a Diagnosis
Acronym
ASSORT
Official Title
Describing, Detecting and Orienting Adults Without Intellectual Disability Asking for an Autism Spectrum Disorder Diagnosis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DONALD T list
Arm Type
Other
Arm Description
adults on the DONALD T list seeking diagnostic advice on autism spectrum disorder or asperger's syndrome
Intervention Type
Other
Intervention Name(s)
screening and diagnostic assessment DONALD T unit list
Intervention Description
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
Primary Outcome Measure Information:
Title
Autism Diagnostic Observation Schedule (ADOS-2)
Description
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
Time Frame
3 months
Title
Adult Asperger's Assessment (AAA)
Description
Semi-structured clinical interview, with the patient and an informant, To evaluate social interaction, restricted activities, communication, magination, additional criteria
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Vineland Adaptative Behavior Scale (VABS-2)
Description
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).
Time Frame
3 months
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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).
Time Frame
3 months
Title
Liebowitz Social Anxiety Scale (LSAS)
Description
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.
Time Frame
3 months
Title
Yale-Brown Scale(Y-BOCS)
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SONIE SANDRINE, MD PH
Organizational Affiliation
Centre Hospitalier le Vinatier (BRON, France)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier Le Vinatier
City
Bron
State/Province
Aura
ZIP/Postal Code
69678
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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Characterizing ASD Adult Population Asking for a Diagnosis
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