Adaptation of the NEAR Cognitive Remediation Method to Child and Adult Autism by Including Social Scenarios and Skills

Recruiting now · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT05786898

Run by

Centre Hospitalier St Anne

People needed

66

Starts

2023-01-24

Expected to finish

2026-12-15

Last updated by the study team

2023-03-28

Who can join

Age: 13 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• GHU Paris Saint-Anne — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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