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NCT Number: NCT05786898

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

13 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GHU Paris Saint-Anne

Paris, France

Location status: Recruiting

Location contact

Isabelle Amado

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Compliance

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

    number of sessions correctly completed/number of sessions planned

  2. Enrollment rate

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

    number of subjects recruited/number of subjects selected

  3. Retention rate

    Time frame: At 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 outcomes

  1. Neuropsychological assessment: attentional performance

    Time frame: 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

    D2-R test

  2. Neuropsychological assessment : processing speed

    Time frame: 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

    D2 test

  3. Neuropsychological assessment : flexibility (1)

    Time frame: 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

    Color Trail Test (raw score)

  4. Neuropsychological assessment : flexibility (2)

    Time frame: 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

    verbal fluency test (raw score and z-score)

  5. Neuropsychological assessment : flexibility (3)

    Time frame: 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

    Stroop test (raw score and z-score)

  6. Neuropsychological assessment : working memory

    Time frame: 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

    Child memory scale for minor <16 years, Wechsler's memory scale for other participants

  7. Functional assessment: quality of life

    Time frame: 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

    World Health Organization Quality of Life-BREF (WHO QOL-BREF) (26 items rated on a 5-level scale (score from 1 to 5))

  8. Functional assessment : conversational skills

    Time frame: 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

    CCC-2 (Children's Communication Check list) for minors <16 years (Raw Score, Scaled Score, Percentile)

  9. Functional assessment : conversational skills (2)

    Time frame: 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

    Pomini's Conversational Skills Scale (1999) for other participants (16 items, score from 0 to 3 for each ; maximum total score : 48)

  10. Functional assessment: self-esteem

    Time frame: 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

    Rosenberg's Self-Esteem Scale (10 items, score from 1 to 4 for each - total score between 10 and 40)

  11. Functional assessment: global functioning

    Time frame: 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

    Global assessment of functioning scale (total score between 0 and 100)

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Nailler

CONTACT

[email protected]

01.45.65.76.78

Sponsors and collaborators

Lead sponsor

Centre Hospitalier St Anne

Other

Registry information

Official study title

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

Acronym: NEAR-TSA

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 28, 2023
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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