Autism Spectrum DisorderNEAR-TSANCT05786898
Adaptation of the NEAR Cognitive Remediation Method to Child and Adult Autism by Including Social Scenarios and Skills
A study testing NEAR-TSA in people with Autism Spectrum Disorder, run by Centre Hospitalier St Anne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 40 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- NEAR-TSA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2023to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
GHU Paris Saint-Anne
Paris
Isabelle Amado, i.amado@ghu-paris.fr
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- NEAR-TSA
- Keywords
- Autism Spectrum Disorder, Cognitive remediation, Children, Adults
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEAR-TSAOther
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
| Study group | Role | What they receive |
|---|---|---|
| NEAR TSA | Experimental | Neuropsychological and Educational Approach of Cognitive Remediation, adapted for autism (NEAR-TSA) Receives: Other: NEAR-TSA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
number of sessions correctly completed/number of sessions planned
Measured: 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
Measured: 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
Measured: 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
D2-R test
Measured: 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
D2 test
Measured: 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)
Color Trail Test (raw score)
Measured: 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)
verbal fluency test (raw score and z-score)
Measured: 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)
Stroop test (raw score and z-score)
Measured: 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 : working memory
Child memory scale for minor <16 years, Wechsler's memory scale for other participants
Measured: 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
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))
Measured: 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
Functional assessment : conversational skills
CCC-2 (Children's Communication Check list) for minors <16 years (Raw Score, Scaled Score, Percentile)
Measured: 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
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)
Measured: 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
Functional assessment: self-esteem
Rosenberg's Self-Esteem Scale (10 items, score from 1 to 4 for each - total score between 10 and 40)
Measured: 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
Functional assessment: global functioning
Global assessment of functioning scale (total score between 0 and 100)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start24 Jan 2023
- Primary completion24 Aug 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Amado, Principal investigator, GHU Paris Saint-Anne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786898
- Sponsor's protocol ID
- D22-P018
- Acronym
- NEAR-TSA
- Status last verified
- Nov 2022
- First submitted
- 13 Dec 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05786898
- Acronym / sponsor ID
- NEAR-TSA / D22-P018
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Cognitive remediation, Children, Adults
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 24 Aug 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NEAR TSA | Experimental | Other: NEAR-TSANeuropsychological and Educational Approach of Cognitive Remediation, adapted for autism (NEAR-TSA) |
Who may qualify
- Ages
- 13 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEAR-TSANeuropsychological 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 | Other | NEAR TSA |
Primary outcome
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
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
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
11 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isabelle Amado principal investigator
GHU Paris Saint-Anne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEAR-TSA in people with Autism Spectrum Disorder, run by Centre Hospitalier St Anne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Nailler (01.45.65.76.78, ext.nailler@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: At the end of the intervention (Month 4 for adults participants, Month 8 for minor participants)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.