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

NCT05786898 | Recruiting

• 1 other identifier: D22-P018
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Cognitive remediation; Children; Adults

Outcome Measures

Primary Outcomes (3)

• Compliance

  number of sessions correctly completed/number of sessions planned

  At the end of the intervention (Month 4 for adults participants, Month 8 for minor participants)

• Enrollment rate

  number of subjects recruited/number of subjects selected

  at the end of the inclusion period (up to 24 months after the start of the research)

• Retention rate

  Number of subjects in post evaluation (T2)) / number of subjects recruited

  At T2 (between Mont 4 and Month 5 for adults participants ; between Month 8 and Month 9 for minor participants)

Secondary Outcomes (11)

• Neuropsychological assessment: attentional performance

  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

• Neuropsychological assessment : processing speed

  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

• 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 session

• 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 session

• 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 session

Study Arms (1)

NEAR TSA

EXPERIMENTAL

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

Other: NEAR-TSA

Interventions

NEAR-TSA 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

NEAR TSA

Eligibility Criteria

• Age: 13 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier St Anne: lead

Study Sites (1)

GHU Paris Saint-Anne

Paris, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Isabelle Amado

  GHU Paris Saint-Anne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Nailler

CONTACT

01.45.65.76.78; ext.nailler@ghu-paris.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: March 28, 2023
• Study Start: January 24, 2023
• Primary Completion (Estimated): August 24, 2026
• Study Completion (Estimated): December 15, 2026
• Last Updated: March 28, 2023

Record last verified: 2022-11

Locations

FR (1)