NCT05786898Recruiting
Adaptation of the NEAR Cognitive Remediation Method to Child and Adult Autism by Including Social Scenarios and Skills
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
Source: ClinicalTrials.gov · Last updated 28 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- First submitted
- 13 Dec 2022
- Start date
- 24 Jan 2023
- Primary completion date
- 24 Aug 2026
- Lead sponsor
- Centre Hospitalier St Anne
- Diseases
- Autism
- NCT number
- NCT05786898
What you commit to
- Study type: Interventional
- Planned participants: 66
- From 24 Jan 2023 to the primary completion date, 24 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously known diagnosis of intellectual disability
- Persons treated with electroconvulsive therapy within the last 6 months
- Treatment with daytime anxiolytics, and treatment with anticholinergic correctors
Other illness
- Uncorrected sensory perception disorder
Other
- Misunderstanding of questions or instructions given during the diagnostic interview
- Proven neurological pathology
- Patient participating in another research study with an exclusion period still in progress at inclusion
- 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
Who the study is looking for
- 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.
Age in the registry: 13 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GHU Paris Saint-Anne Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.