NCT05786898: NEAR-TSA

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

Recruiting now NA Last updated 28 March 2023

What this trial tests

NA trial testing NEAR-TSA in Autism Spectrum Disorder in 66 participants. Currently enrolling.

Timeline

24 January 2023

Primary endpoint
24 August 2026

15 December 2026

Quick facts

Lead sponsor	Centre Hospitalier St Anne
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	24 January 2023
Primary completion	24 August 2026
Estimated completion	15 December 2026
Sites	1 location across France

Drugs / interventions tested

• NEAR-TSA

Conditions studied

• Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

Centre Hospitalier St Anne

Who can join

Adults 13 to 40, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.