Handwritten Text Production in Adults With Autism (PEMTAA)

March 8, 2024 updated by: Evan Launay, Centre Hospitalier de Niort

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:

  • 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).

Study Overview

Status

Recruiting

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 Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm : Adults with autism spectrum disorder
All of the interventions described below
  • 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
Active Comparator: Control arm : Adults with typical development
All of the interventions described below
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identifying links between specific deficits of ASD and difficulties in written production
Time Frame: 18 months
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
Identifying links between the severity of ASD and difficulties in written production
Time Frame: 18 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Evan E Launay, Mr, Hospital Center of Niort (France)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

February 12, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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