Clinical trial NCT06304701: Handwritten Text Production in Adults With Autism
Official title: Analysis on Graphic Tablet of Motor and Cognitive Components of Written Production in Adults With and Without Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Written production
Handwriting
Graphomotor skills
Language
Graphic tablet
Lead sponsor: Centre Hospitalier de Niort
Sponsor class: OTHER
Collaborators: name: University of Poitiers
First posted: 2024-03-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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.
* 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.

Eligibility criteria: Inclusion Criteria for experimental group only:

* 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

Exclusion Criteria for experimental group only:

* Diagnosis of any other NDD than ASD (e.g., Attention Deficit Hyperactivity Disorder, Specific Learning Disorder, Language Disorder, Coordination Disorder, Intellectual Disorder)

Exclusion Criteria for control group only:

- 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
* 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)

Primary outcomes:
measure: Assessment of psycholinguistic and graphomotor characteristics of written production in patients with autism spectrum disorder (asd)
timeFrame: 18 months
Secondary outcomes:
measure: Identifying links between specific deficits of ASD and difficulties in written production
timeFrame: 18 months
measure: Identifying links between the severity of ASD and difficulties in written production
timeFrame: 18 months
Other outcomes:
Locations:
city: Niort
country: France
facility: Centre Hospitalier de Niort
Study officials:
affiliation: Hospital Center of Niort (France)
name: Evan E Launay, Mr
role: PRINCIPAL_INVESTIGATOR
References: