NCT05786898Toboroz
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2023. márc. 28. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 66 (tervezett)
- Első benyújtás
- 2022. dec. 13.
- Kezdés
- 2023. jan. 24.
- Elsődleges befejezés
- 2026. aug. 24.
- Fő szponzor
- Centre Hospitalier St Anne
- Betegségek
- Autizmus spektrumzavar
- NCT-szám
- NCT05786898
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 66
- 2023. jan. 24. és az elsődleges befejezés (2026. aug. 24.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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
Más betegség
- Uncorrected sensory perception disorder
Egyéb
- 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
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 13 év – 40 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| GHU Paris Saint-Anne | Paris | Franciaország | Toboroz |
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