Autism Spectrum DisorderASSORTNCT04147988
Characterizing ASD Adult Population Asking for a Diagnosis
A study testing screening and diagnostic assessment DONALD T unit list in people with Autism Spectrum Disorder, run by Hôpital le Vinatier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- screening and diagnostic assessment DONALD T unit list
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 27 Sep 2019to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- to be on Donald-T's waiting list
- be at least 18 years old
Who cannot join
- Any participant who does not meet the inclusion criteria will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- screening and diagnostic assessment DONALD T unit list
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening and diagnostic assessment DONALD T unit listOther
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
| Study group | Role | What they receive |
|---|---|---|
| DONALD T list | Other | adults on the DONALD T list seeking diagnostic advice on autism spectrum disorder or asperger's syndrome Receives: Other: screening and diagnostic assessment DONALD T unit list |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start27 Sep 2019
- Primary completion31 Jul 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SONIE SANDRINE, MD PH, Principal investigator, Centre Hospitalier le Vinatier (BRON, France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147988
- Sponsor's protocol ID
- 2019-A01130-57
- Acronym
- ASSORT
- Status last verified
- Jan 2022
- First submitted
- 25 Oct 2019
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Describing, Detecting and Orienting Adults Without Intellectual Disability Asking for an Autism Spectrum Disorder Diagnosis
- ClinicalTrials.gov ID
- NCT04147988
- Acronym / sponsor ID
- ASSORT / 2019-A01130-57
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| DONALD T list | Other | Other: screening and diagnostic assessment DONALD T unit listadults on the DONALD T list seeking diagnostic advice on autism spectrum disorder or asperger's syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- to be on Donald-T's waiting list
- be at least 18 years old
Key exclusion criteria (1 listed)
- Any participant who does not meet the inclusion criteria will not be included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| screening and diagnostic assessment DONALD T unit listScreening 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 | Other | DONALD T list |
Primary outcome
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
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
4 secondary outcomes
Vineland Adaptative Behavior Scale (VABS-2)
Time frame: 3 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 3 months
Liebowitz Social Anxiety Scale (LSAS)
Time frame: 3 months
Yale-Brown Scale(Y-BOCS)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SONIE SANDRINE, MD PH principal investigator
Centre Hospitalier le Vinatier (BRON, France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screening and diagnostic assessment DONALD T unit list in people with Autism Spectrum Disorder, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autism Diagnostic Observation Schedule (ADOS-2) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.