Autism Spectrum DisorderPEMTAANCT06304701
Handwritten Text Production in Adults With Autism
A study testing Cognitive and writing tests in people with Autism Spectrum Disorder, run by Centre Hospitalier de Niort at 1 site in France.
Trial summary
The main objective is to assess the psycholinguistic and graphomotor characteristics of written production in patients with ASD. The secondary objectives are: Identifying links between specific deficits of ASD and difficulties in written production. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Cognitive and writing tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2023to May 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASD diagnosis according to DSM-5 criteria and established by an interdisciplinary
- Inclusion Criteria for both experimental and control groups:
- Age ≥ 18 years Age ≥ 18 years and matching typical adult subjects to ASD individuals in age (plus or minus 5 years), sex, and education level
- The person participating in the research has read, understood, and signed the study consent form
- The person is proficient in the French language
- The person is affiliated with a social security system
Who cannot join
- Diagnosis of any other NDD than ASD (e.g., Attention Deficit Hyperactivity Disorder, Specific Learning Disorder, Language Disorder, Coordination Disorder, Intellectual Disorder)
- Diagnosis of any NDD (ASD, Attention Deficit Hyperactivity Disorder, Specific Learning Disorder, Language Disorder, Coordination Disorder, Intellectual Disorder)
- Exclusion Criteria for both experimental and control groups:
- Refusal of the individual to participate in the study
- Presence of severe visual impairment
- Known pregnancy
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- Individual deprived of liberty
- Individual under guardianship or curators
- Presence of concurrent psychotropic medication treatments not stabilized, initiated within the last 2 months: antipsychotics, mood stabilizers, antiepileptics, psychostimulants, antidepressants
- Presence of upper limb motor impairment, with or without devices
- Presence of diagnosed neurological or psychiatric disorders (e.g., Schizophrenia Spectrum Disorder or other psychotic disorders), presence of a general or metabolic pathology known to have an impact on cognitive efficiency and/or motor skills of the individual (e.g., Epilepsy, Tics and Tourette Syndrome, Neuro-muscular Syndrome, Metabolic Neurological Syndromes, neoplasms)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Niort
Niort, 79000
Diane D Chuillet-Moreau, Mrs, +33549782049, diane.chuillet-moreau@ch-niort.fr
About this study
Official title: Analysis on Graphic Tablet of Motor and Cognitive Components of Written Production in Adults With and Without Autism Spectrum Disorder
The main objective is to assess the psycholinguistic and graphomotor characteristics of written production in patients with ASD.
The secondary objectives are:
Read more
- Identifying links between specific deficits of ASD and difficulties in written production.
- Identifying links between the severity of ASD and difficulties in written production.
The primary evaluation criterion is the quantity of written production, namely the number of words produced in 5 minutes on a text copying task (BHK) and in 15 minutes on each of the two written production tasks (descriptive and persuasive).
The secondary evaluation criteria are:
- Graphomotor indicators of written production (writing speed, pre-writing time, pause time, writing time, handwriting size, results obtained in BHK (number of words produced, letter height, line parallelism, telescoping, ambiguous letters).
- Cognitive and psycholinguistic indicators of written production (presence of titles, presence of paragraphs, number of sentences, number of words per sentence, lexical richness, lexical field, number of action verbs, morphological complexity, number of syntactic markers related to oneself, number of syntactic markers related to others, number of spelling errors, evaluation of the overall quality of the produced text).
- Results obtained in tests (writing habits questionnaire, Autism Diagnostic Observation Scale (second edition), Wechsler Adult Intelligence Scale (fourth edition) - Similarities subtest, Wechsler Adult Intelligence Scale (fourth edition) - Vocabulary subtest, Rey Figure, MASC).
Read the detailed description
Context :
Autism Spectrum Disorder (ASD) is one of the neurodevelopmental disorders (NDD) characterized by persistent deficits in communication and social interaction, and restricted and repetitive patterns of behavior, interests, and activities (DSM-5 diagnostic criteria; American Psychiatric Association, 2013). These symptoms are present from early developmental stages and correspond to neurological conditions characterized by structural and/or functional brain abnormalities.
While diagnosis is typically made in childhood (average age of 4 years (Rogé, 2019)), many adults seek diagnostic evaluation for ASD from autism resource centers (CRA). This is partly due to the diversity of symptoms that can lead to a 'diagnostic odyssey' spanning several years (Rutherford et al., 2016). Even though the dyad identified by DSM-5 allows for precise diagnosis, many other clinical signs can be found in patients with ASD (mood disorders, sleep disorders, impulsivity/hyperactivity, anxiety, motor disorders, language disorders, etc.), which can complicate diagnosis and delay the implementation of early and appropriate intervention.
In this context, an interesting avenue is the study of writing characteristics in patients with ASD. Indeed, several studies show that patients with ASD present deficits in motor skills as well as in several psycholinguistic domains such as grammar, morphology, and phonology (Habib et al., 2019). Furthermore, individuals with ASD may exhibit specific semantic and pragmatic impairments (Bishop, 1989). These findings may provide additional useful clues in a perspective of differential diagnosis and understanding of cognitive functioning.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Cognitive and writing tests
- Keywords
- Written production, Handwriting, Graphomotor skills, Language, Graphic tablet
- Medical subject headings
- Autism Spectrum Disorder, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive and writing testsDiagnostic test
- Wechsler Adult Intelligence Scale - fourth edition (Similarities and Vocabulary subtests)
- MASC (Movie for assessment of social cognition)
- Rey figure
- BHK (Quick Writing Assessment Scale)
- Descriptive text writing
- Persuasive text writing
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm : Adults with autism spectrum disorder | Experimental | All of the interventions described below Receives: Diagnostic Test: Cognitive and writing tests |
| Control arm : Adults with typical development | Active comparator | All of the interventions described below Receives: Diagnostic Test: Cognitive and writing tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of psycholinguistic and graphomotor characteristics of written production in patients with autism spectrum disorder (asd)
Number of words produced in both 3 written production tasks (copy, descriptive text, and persuasive text) : adults with ASD vs adults with typical development
Measured: 18 months
Secondary outcomes (2)
Identifying links between specific deficits of ASD and difficulties in written production
Identifying links between theory of mind (MASC results), which is one of the main explicative model of the autistic functioning, and number of words produced in both 3 written production tasks. Indeed, the writing activity involves taking into account the recipient, and thus the theory of mind.
Measured: 18 months
Identifying links between the severity of ASD and difficulties in written production
Identifying links between the severity of ASD (ADOS-2 results) and number of words produced in both 3 written production tasks. Indeed, the severity of ASD can affect the ability to communicate, which is one of the diagnostic criteria of ASD, and thus the ability to produce a text.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start29 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study is part of category 2 of research involving humans and which corresponds to an interventional study with minimal risks and constraints. The patient is asked to return to carry out this study.
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Niort
- Sponsor type
- University, hospital or other
- Collaborators
- University of Poitiers
- Responsible party
- Principal investigator, Evan Launay, Centre Hospitalier de Niort
- Investigators
- Evan E Launay, Mr, Principal investigator, Hospital Center of Niort (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304701
- Sponsor's protocol ID
- PI-2023-08
- Acronym
- PEMTAA
- Status last verified
- Mar 2024
- First submitted
- 12 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- 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 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis on Graphic Tablet of Motor and Cognitive Components of Written Production in Adults With and Without Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT06304701
- Acronym / sponsor ID
- PEMTAA / PI-2023-08
- Conditions
- Autism Spectrum Disorder
- Keywords
- Written production, Handwriting, Graphomotor skills, Language, Graphic tablet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Centre Hospitalier de NiortUniversity, hospital or other
- Collaborators
- University of Poitiers
- Study start
- 29 Nov 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 12 Mar 2024 (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 main objective is to assess the psycholinguistic and graphomotor characteristics of written production in patients with ASD.
The secondary objectives are:
- Identifying links between specific deficits of ASD and difficulties in written production.
- Identifying links between the severity of ASD and difficulties in written production.
The primary evaluation criterion is the quantity of written production, namely the number of words produced in 5 minutes on a text copying task (BHK) and in 15 minutes on each of the two written production tasks (descriptive and persuasive).
The secondary evaluation criteria are:
- Graphomotor indicators of written production (writing speed, pre-writing time, pause time, writing time, handwriting size, results obtained in BHK (number of words produced, letter height, line parallelism, telescoping, ambiguous letters).
- Cognitive and psycholinguistic indicators of written production (presence of titles, presence of paragraphs, number of sentences, number of words per sentence, lexical richness, lexical field, number of action verbs, morphological complexity, number of syntactic markers related to oneself, number of syntactic markers related to others, number of spelling errors, evaluation of the overall quality of the produced text).
- Results obtained in tests (writing habits questionnaire, Autism Diagnostic Observation Scale (second edition), Wechsler Adult Intelligence Scale (fourth edition) - Similarities subtest, Wechsler Adult Intelligence Scale (fourth edition) - Vocabulary subtest, Rey Figure, MASC).
Detailed description
Context :
Autism Spectrum Disorder (ASD) is one of the neurodevelopmental disorders (NDD) characterized by persistent deficits in communication and social interaction, and restricted and repetitive patterns of behavior, interests, and activities (DSM-5 diagnostic criteria; American Psychiatric Association, 2013). These symptoms are present from early developmental stages and correspond to neurological conditions characterized by structural and/or functional brain abnormalities.
While diagnosis is typically made in childhood (average age of 4 years (Rogé, 2019)), many adults seek diagnostic evaluation for ASD from autism resource centers (CRA). This is partly due to the diversity of symptoms that can lead to a 'diagnostic odyssey' spanning several years (Rutherford et al., 2016). Even though the dyad identified by DSM-5 allows for precise diagnosis, many other clinical signs can be found in patients with ASD (mood disorders, sleep disorders, impulsivity/hyperactivity, anxiety, motor disorders, language disorders, etc.), which can complicate diagnosis and delay the implementation of early and appropriate intervention.
In this context, an interesting avenue is the study of writing characteristics in patients with ASD. Indeed, several studies show that patients with ASD present deficits in motor skills as well as in several psycholinguistic domains such as grammar, morphology, and phonology (Habib et al., 2019). Furthermore, individuals with ASD may exhibit specific semantic and pragmatic impairments (Bishop, 1989). These findings may provide additional useful clues in a perspective of differential diagnosis and understanding of cognitive functioning.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is part of category 2 of research involving humans and which corresponds to an interventional study with minimal risks and constraints. The patient is asked to return to carry out this study.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm : Adults with autism spectrum disorder | Experimental | Diagnostic Test: Cognitive and writing testsAll of the interventions described below |
| Control arm : Adults with typical development | Active comparator | Diagnostic Test: Cognitive and writing testsAll of the interventions described below |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ASD diagnosis according to DSM-5 criteria and established by an interdisciplinary
- Age ≥ 18 years Age ≥ 18 years and matching typical adult subjects to ASD individuals in age (plus or minus 5 years), sex, and education level
- The person participating in the research has read, understood, and signed the study consent form
- The person is proficient in the French language
- The person is affiliated with a social security system
Key exclusion criteria (11 listed)
- Diagnosis of any other NDD than ASD (e.g., Attention Deficit Hyperactivity Disorder, Specific Learning Disorder, Language Disorder, Coordination Disorder, Intellectual Disorder)
- Diagnosis of any NDD (ASD, Attention Deficit Hyperactivity Disorder, Specific Learning Disorder, Language Disorder, Coordination Disorder, Intellectual Disorder)
- Refusal of the individual to participate in the study
- Presence of severe visual impairment
- Known pregnancy
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 |
|---|---|---|
| Cognitive and writing tests* Wechsler Adult Intelligence Scale - fourth edition (Similarities and Vocabulary subtests) * MASC (Movie for assessment of social cognition) * Rey figure * BHK (Quick Writing Assessment Scale) * Descriptive text writing * Persuasive text writing | Diagnostic test | Control arm : Adults with typical development, Experimental arm : Adults with autism spectrum disorder |
Primary outcome
Assessment of psycholinguistic and graphomotor characteristics of written production in patients with autism spectrum disorder (asd)
Time frame: 18 months
Number of words produced in both 3 written production tasks (copy, descriptive text, and persuasive text) : adults with ASD vs adults with typical development
2 secondary outcomes
Identifying links between specific deficits of ASD and difficulties in written production
Time frame: 18 months
Identifying links between the severity of ASD and difficulties in written production
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Evan E Launay, Mr principal investigator
Hospital Center of Niort (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 Cognitive and writing tests in people with Autism Spectrum Disorder, run by Centre Hospitalier de Niort 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evan E Launay, Mr (+33549783846, evan.launay@ch-niort.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of psycholinguistic and graphomotor characteristics of written production in patients with autism spectrum disorder (asd) (time frame: 18 months). 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 12 Mar 2024.