Informations générales (source: ClinicalTrials.gov)
NEAR-TSA : Adaptation of the NEAR (Neuropsychological and Educational Approach of Cognitive Remediation) Cognitive Remediation Method to Child and Adult Autism by Including Social Scenarios and Skills
Interventional
N/A
Centre Hospitalier St Anne (Voir sur ClinicalTrials)
janvier 2023
décembre 2026
02 mai 2026
The investigators currently provide the NEAR method (neuropsychological educational
approach to cognitive remediation) for people with neurocognitive difficulties, without
distinguishing between ASD and schizophrenia.
However, the NEAR method does not address social cognition in the stimulated functions.
The aim of this study is to add social scenarios to this neurocognitive method in order
to improve not only neurocognitive functions, but also social cognition. Thus, NEAR would
be in this adapted form a method that could be completely adapted to autism spectrum
disorders in preadolescents and adults.
The study will include participants aged 13-40 years, with a diagnosis of ASD.
The NEAR TSA method will include 32 sessions:
- one session (90-120 min, with one or two breaks) per week for 32 weeks (8 months),
for minor participants.
- two sessions (90 minutes each, with no breaks) per week for 16 weeks (4 months), for
adult participants.
The method includes 30 minutes of computerized exercises, 15 minutes of discussion on the
exercises performed and the strategies applied, and the rest of the time for "bridging
groups".
Three evaluation are proposed:
- an initial clinical and functional evaluation (T1), before the beginning of the
program,
- a second clinical, functional and neuropsychological evaluation (T2), within one
month since the end of the program
- a third clinical, functional and neuropsychologica evaluationl (T3), three months
after the end of the program.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Isabelle Amado | Contact (sur clinicalTrials) | |||
Critères
Tous
- Patients with a diagnosis Autism Spectrum Disorder (ASD) - (DSM5)
- Attending one of the outpatient units participating in the research
- Diagnosis confirmed by the ADI (Autism Diagnostic Interview) with at least one
parent present; or by the ADOS (Autism Diagnosis Observation Schedule)
- Score of at least 7 on the WISC5 (children) or WAIS4 (adults) comprehension subtest
- Patient whose neuropsychological evaluation shows neurocognitive impairment as
assessed by the neuropsychologist
- Level of comprehension and communication allowing to understand the instructions of
the exercises presented on the screen.
- For children, persons who can attend a non-specialized school
- If the patient is being treated with a psychotropic drug: stability of treatment for
more than one month.
Exclusion Criteria:
- Previously known diagnosis of intellectual disability
- Misunderstanding of questions or instructions given during the diagnostic interview
- Proven neurological pathology
- Persons treated with electroconvulsive therapy within the last 6 months
- Uncorrected sensory perception disorder
- Patient participating in another research study with an exclusion period still in
progress at inclusion
- Treatment with daytime anxiolytics, and treatment with anticholinergic correctors
- Pregnant or breastfeeding woman
- Participants who have had cognitive remediation in the last two years
Specific exclusion criteria for the "adult" group:
- heterogeneous levels of development highlighted in the diagnostic workup including an
examination of cognitive functions
Specific exclusion criteria for the "children" group:
- out-of-school children