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OpenTrials
Completed

NCT Number: NCT04147988

Characterizing ASD Adult Population Asking for a 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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier Le Vinatier

Bron, AURA, 69678, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Autism Diagnostic Observation Schedule (ADOS-2)

    Time frame: 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)

    Time frame: 3 months

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

Secondary outcomes

  1. Vineland Adaptative Behavior Scale (VABS-2)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hôpital le Vinatier

Other

Registry information

Official study title

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

Acronym: ASSORT

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2019
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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