Clinical trial NCT05786898: Adaptation of the NEAR Cognitive Remediation Method to Child and Adult Autism by Including Social Scenarios and Skills
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism Spectrum Disorder
Cognitive remediation
Children
Adults
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 66
Sex: ALL
Minimum age (years): 13
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Inclusion age:two samples: 13 to 15 years old and 16 to 40 years old the clinical evaluation (T1,T2, T3) includes: global functional assessment; questionnaires for children and adults including the self esteem questionnaire, quality of life (who_QOL Bref), social responsiveness scale, conversational skills (CCC-2 for children; Pomini Scale for adults), intrinsic motivational scale (Medalia), Satisfaction scale (CSQ8).

The Neuropsychological evaluation (T1, T2, T3) includes: WISC5 (children), WAIS 4 (adults), stroop test, D2-R, Child memory scale or Wechsler Memory scale for adults, Brief, color trail test, verbal fluency.

Near TSA is a group cognitive remediation method, including one weekly session for children or 2 weekly sessions for adults with 30 mn of neuropsychological exercices, 15 mn of discussion about exercices and strategies, and 30 mn of bridging groups including social scritps.

Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: Compliance
timeFrame: At the end of the intervention (Month 4 for adults participants, Month 8 for minor participants)
measure: Enrollment rate
timeFrame: at the end of the inclusion period (up to 24 months after the start of the research)
measure: Retention rate
timeFrame: At T2 (between Mont 4 and Month 5 for adults participants ; between Month 8 and Month 9 for minor participants)
Secondary outcomes:
measure: Neuropsychological assessment: attentional performance
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the sessions
measure: Neuropsychological assessment : processing speed
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the sessions
measure: Neuropsychological assessment : flexibility (1)
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the session
measure: Neuropsychological assessment : flexibility (2)
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the session
measure: Neuropsychological assessment : flexibility (3)
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the session
measure: Neuropsychological assessment : working memory
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the sessions
measure: Functional assessment: quality of life
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the sessions
measure: Functional assessment : conversational skills
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the sessions
measure: Functional assessment : conversational skills (2)
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the sessions
measure: Functional assessment: self-esteem
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the sessions
measure: Functional assessment: global functioning
timeFrame: before the start of the NEAR TSA sessions, within one month of the end of the sessions and 3 to 4 months after the end of the sessions
Other outcomes:
Locations:
city: Paris
country: France
facility: GHU Paris Saint-Anne
Study officials:
affiliation: GHU Paris Saint-Anne
name: Isabelle Amado
role: PRINCIPAL_INVESTIGATOR
References: