Handwritten Text Production in Adults With Autism

NCT ID: NCT06304701

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-29

Study Completion Date

2025-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental arm : Adults with autism spectrum disorder

All of the interventions described below

Group Type EXPERIMENTAL

Cognitive and writing tests

Intervention Type 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

All of the interventions described below

Group Type ACTIVE_COMPARATOR

Cognitive and writing tests

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Poitiers

OTHER

Sponsor Role collaborator

Centre Hospitalier de Niort

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Evan Launay

Psychologist and PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Evan E Launay, Mr

Role: PRINCIPAL_INVESTIGATOR

Hospital Center of Niort (France)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier de Niort

Niort, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Evan E Launay, Mr

Role: CONTACT

+33549783846

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Diane D Chuillet-Moreau, Mrs

Role: primary

+33549782049

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI-2023-08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.