Skip to content

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05786898
Acronym
NEAR-TSA
Enrollment
66
Registered
2023-03-28
Start date
2023-01-24
Completion date
2026-12-15
Last updated
2023-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, Cognitive remediation, Children, Adults

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.

Interventions

OTHERNEAR-TSA

Neuropsychological and Educational Approach of Cognitive Remediation adapted to autism 32 sessions spread over 4 to 8 months (1 session per week for minors, 2 sessions per week for adults), lasting 90 to 120 minutes

Sponsors

Centre Hospitalier St Anne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
13 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ComplianceAt the end of the intervention (Month 4 for adults participants, Month 8 for minor participants)number of sessions correctly completed/number of sessions planned
Enrollment rateat the end of the inclusion period (up to 24 months after the start of the research)number of subjects recruited/number of subjects selected
Retention rateAt T2 (between Mont 4 and Month 5 for adults participants ; between Month 8 and Month 9 for minor participants)Number of subjects in post evaluation (T2)) / number of subjects recruited

Secondary

MeasureTime frameDescription
Neuropsychological assessment : flexibility (2)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 sessionverbal fluency test (raw score and z-score)
Neuropsychological assessment : flexibility (3)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 sessionStroop test (raw score and z-score)
Neuropsychological assessment : working memorybefore 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 sessionsChild memory scale for minor \<16 years, Wechsler's memory scale for other participants
Functional assessment: quality of lifebefore 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 sessionsWorld Health Organization Quality of Life-BREF (WHO QOL-BREF) (26 items rated on a 5-level scale (score from 1 to 5))
Neuropsychological assessment: attentional performancebefore 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 sessionsD2-R test
Functional assessment : conversational skills (2)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 sessionsPomini's Conversational Skills Scale (1999) for other participants (16 items, score from 0 to 3 for each ; maximum total score : 48)
Functional assessment: self-esteembefore 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 sessionsRosenberg's Self-Esteem Scale (10 items, score from 1 to 4 for each - total score between 10 and 40)
Functional assessment: global functioningbefore 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 sessionsGlobal assessment of functioning scale (total score between 0 and 100)
Functional assessment : conversational skillsbefore 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 sessionsCCC-2 (Children's Communication Check list) for minors \<16 years (Raw Score, Scaled Score, Percentile)
Neuropsychological assessment : processing speedbefore 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 sessionsD2 test
Neuropsychological assessment : flexibility (1)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 sessionColor Trail Test (raw score)

Countries

France

Contacts

Primary ContactLaura Nailler
ext.nailler@ghu-paris.fr01.45.65.76.78

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026