search
Back to results

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

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NEAR-TSA
Sponsored by
Centre Hospitalier St Anne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Cognitive remediation, Children, Adults

Eligibility Criteria

13 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GHU Paris Saint-AnneRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NEAR TSA

Arm Description

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

Outcomes

Primary Outcome Measures

Compliance
number of sessions correctly completed/number of sessions planned
Enrollment rate
number of subjects recruited/number of subjects selected
Retention rate
Number of subjects in post evaluation (T2)) / number of subjects recruited

Secondary Outcome Measures

Neuropsychological assessment: attentional performance
D2-R test
Neuropsychological assessment : processing speed
D2 test
Neuropsychological assessment : flexibility (1)
Color Trail Test (raw score)
Neuropsychological assessment : flexibility (2)
verbal fluency test (raw score and z-score)
Neuropsychological assessment : flexibility (3)
Stroop test (raw score and z-score)
Neuropsychological assessment : working memory
Child memory scale for minor <16 years, Wechsler's memory scale for other participants
Functional assessment: quality of life
World Health Organization Quality of Life-BREF (WHO QOL-BREF) (26 items rated on a 5-level scale (score from 1 to 5))
Functional assessment : conversational skills
CCC-2 (Children's Communication Check list) for minors <16 years (Raw Score, Scaled Score, Percentile)
Functional assessment : conversational skills (2)
Pomini's Conversational Skills Scale (1999) for other participants (16 items, score from 0 to 3 for each ; maximum total score : 48)
Functional assessment: self-esteem
Rosenberg's Self-Esteem Scale (10 items, score from 1 to 4 for each - total score between 10 and 40)
Functional assessment: global functioning
Global assessment of functioning scale (total score between 0 and 100)

Full Information

First Posted
December 13, 2022
Last Updated
March 15, 2023
Sponsor
Centre Hospitalier St Anne
search

1. Study Identification

Unique Protocol Identification Number
NCT05786898
Brief Title
Adaptation of the NEAR Cognitive Remediation Method to Child and Adult Autism by Including Social Scenarios and Skills
Acronym
NEAR-TSA
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
August 24, 2026 (Anticipated)
Study Completion Date
December 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier St Anne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, Cognitive remediation, Children, Adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NEAR TSA
Arm Type
Experimental
Arm Description
Neuropsychological and Educational Approach of Cognitive Remediation, adapted for autism (NEAR-TSA)
Intervention Type
Other
Intervention Name(s)
NEAR-TSA
Intervention Description
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 Outcome Measure Information:
Title
Compliance
Description
number of sessions correctly completed/number of sessions planned
Time Frame
At the end of the intervention (Month 4 for adults participants, Month 8 for minor participants)
Title
Enrollment rate
Description
number of subjects recruited/number of subjects selected
Time Frame
at the end of the inclusion period (up to 24 months after the start of the research)
Title
Retention rate
Description
Number of subjects in post evaluation (T2)) / number of subjects recruited
Time Frame
At T2 (between Mont 4 and Month 5 for adults participants ; between Month 8 and Month 9 for minor participants)
Secondary Outcome Measure Information:
Title
Neuropsychological assessment: attentional performance
Description
D2-R test
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
Title
Neuropsychological assessment : processing speed
Description
D2 test
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
Title
Neuropsychological assessment : flexibility (1)
Description
Color Trail Test (raw score)
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
Title
Neuropsychological assessment : flexibility (2)
Description
verbal fluency test (raw score and z-score)
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
Title
Neuropsychological assessment : flexibility (3)
Description
Stroop test (raw score and z-score)
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
Title
Neuropsychological assessment : working memory
Description
Child memory scale for minor <16 years, Wechsler's memory scale for other participants
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
Title
Functional assessment: quality of life
Description
World Health Organization Quality of Life-BREF (WHO QOL-BREF) (26 items rated on a 5-level scale (score from 1 to 5))
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
Title
Functional assessment : conversational skills
Description
CCC-2 (Children's Communication Check list) for minors <16 years (Raw Score, Scaled Score, Percentile)
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
Title
Functional assessment : conversational skills (2)
Description
Pomini's Conversational Skills Scale (1999) for other participants (16 items, score from 0 to 3 for each ; maximum total score : 48)
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
Title
Functional assessment: self-esteem
Description
Rosenberg's Self-Esteem Scale (10 items, score from 1 to 4 for each - total score between 10 and 40)
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
Title
Functional assessment: global functioning
Description
Global assessment of functioning scale (total score between 0 and 100)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Nailler
Phone
01.45.65.76.78
Email
ext.nailler@ghu-paris.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle Amado
Organizational Affiliation
GHU Paris Saint-Anne
Official's Role
Principal Investigator
Facility Information:
Facility Name
GHU Paris Saint-Anne
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Amado
Email
i.amado@ghu-paris.fr

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs