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

NCT ID: NCT05786898

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2026-12-15

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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NEAR TSA

Neuropsychological and Educational Approach of Cognitive Remediation, adapted for autism (NEAR-TSA)

Group Type: EXPERIMENTAL

NEAR-TSA

Intervention Type: OTHER

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

Interventions

NEAR-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

Intervention Type: OTHER

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

• heterogeneous levels of development highlighted in the diagnostic workup including an examination of cognitive functions

• out-of-school children

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier St Anne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle Amado

Role: PRINCIPAL_INVESTIGATOR

GHU Paris Saint-Anne

Locations

GHU Paris Saint-Anne

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Laura Nailler

Role: CONTACT

ext.nailler@ghu-paris.fr

01.45.65.76.78

Facility Contacts

Isabelle Amado

Role: primary

i.amado@ghu-paris.fr

Other Identifiers

D22-P018

Identifier Type: -

Identifier Source: org_study_id