Handwritten Text Production in Adults With Autism

NCT06304701 | Recruiting

• 1 other identifier: PI-2023-08
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism Spectrum Disorder

Keywords

Written production; Handwriting; Graphomotor skills; Language; Graphic tablet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Identifying links between specific deficits of ASD and difficulties in written production

  18 months

• Identifying links between the severity of ASD and difficulties in written production

  18 months

Study Arms (2)

Experimental arm : Adults with autism spectrum disorder

EXPERIMENTAL

All of the interventions described below

Diagnostic Test: Cognitive and writing tests

Control arm : Adults with typical development

ACTIVE COMPARATOR

All of the interventions described below

Diagnostic Test: Cognitive and writing tests

Interventions

Cognitive and writing tests DIAGNOSTIC_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

Control arm : Adults with typical development; Experimental arm : Adults with autism spectrum disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Centre Hospitalier de Niort: lead
• University of Poitiers: collaborator

Study Sites (1)

Centre Hospitalier de Niort

Niort, 79000, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Language

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication; Behavior

Study Officials

• Evan E Launay, Mr

  Hospital Center of Niort (France)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan E Launay, Mr

CONTACT

+33549783846; evan.launay@ch-niort.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist and PhD student

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 12, 2024
• Study Start: November 29, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)