Improving cognitive and social skills in individuals with autism using the NEAR method
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
NA · Centre Hospitalier St Anne · NCT05786898
This study is testing a new program that helps people with autism, aged 13 to 40, improve their thinking and social skills through fun activities and group sessions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 13 Years to 40 Years |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05786898 on ClinicalTrials.gov |
What this trial studies
This study aims to adapt the NEAR cognitive remediation method to better address the needs of individuals with Autism Spectrum Disorder (ASD) by incorporating social scenarios and skills into the intervention. Participants aged 13 to 40 years will engage in a structured program consisting of weekly sessions over several months, focusing on both neurocognitive and social cognition improvements. The intervention includes a combination of computerized exercises, discussions, and group activities designed to enhance cognitive functions and social interactions. Evaluations will be conducted at multiple time points to assess the effectiveness of the adapted method.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 13 to 40 years with a confirmed diagnosis of Autism Spectrum Disorder.
Not a fit: Patients with a known diagnosis of intellectual disability or those who cannot comprehend the instructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance cognitive and social functioning in individuals with autism, leading to improved quality of life.
How similar studies have performed: While adaptations of cognitive remediation methods have been explored, this specific approach targeting social cognition in autism is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- GHU Paris Saint-Anne — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Isabelle Amado — GHU Paris Saint-Anne
- Study coordinator: Laura Nailler
- Email: ext.nailler@ghu-paris.fr
- Phone: 01.45.65.76.78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Cognitive remediation, Children, Adults