Autism Spectrum Disorder Clinical Trial
— PEMTAAOfficial title:
Analysis on Graphic Tablet of Motor and Cognitive Components of Written Production in Adults With and Without Autism Spectrum Disorder
NCT number | NCT06304701 |
Other study ID # | PI-2023-08 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | November 29, 2023 |
Est. completion date | May 2025 |
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).
Status | Recruiting |
Enrollment | 38 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | Centre Hospitalier de Niort | Niort |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier de Niort | University of Poitiers |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 18 months | |
Secondary | 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. | 18 months | |
Secondary | 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. | 18 months |
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