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Study of the Personal Identity in Adults With Autism Spectrum Disorder Without Intellectual Deficiency (TSASDI)

Primary Purpose

Autism Spectrum Disorders

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
clinical, psychological and neuropsychological assessment
Autobiographical memories Assessment
Autobiographical memories assessment characteristics
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autism Spectrum Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Study A & B, Adults with autism spectrum disorders without intellectual deficiency

Inclusion criteria:

  • adults with autism spectrum disorders
  • 18 to 65 years old

Exclusion criteria:

  • treatment with benzodiazepines

Study A & B, control adults

Inclusion criteria:

  • healthy volunteers
  • 18 to 65 years old

Exclusion criteria:

  • psychiatric disorders

Sites / Locations

  • Hôpitaux universitaires de Strasbourg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Other

Other

Experimental

Experimental

Other

Other

Arm Label

Autism spectrum disorder studyA part1

Autism spectrum disorder studyA part2

Control adults Study A, part 1

Control adults Study A, part 2

Autism spectrum disorder Study B, part 1

Autism spectrum disorder Study B, part 2

Control adults, Study B part 1

Control adults, Study B part 2

Arm Description

The subjects will perform clinical, psychological and neuropsychological assessment. the subjects will do 3 tests about executive functions. Finally, the participants will complete 3 questionnaires about autism and 3 questionnaires about the self concept.

The subjects will perform Autobiographical memories Assessment. The subjects will tell autobiographical memories freely first and secondly by answering focused questions to specify the characteristics of subjects' memories

The subjects will perform clinical, psychological and neuropsychological assessment. The subjects will do 3 tests about executive functions. The participants will complete 3 questionnaires about autism and 3 questionnaires about the self concept.

The subjects will perform Autobiographical memories Assessment. The subjects will tell autobiographical memories freely first and secondly by answering focused questions to specify the characteristics of subjects' memories

The subjects will perform clinical, psychological and neuropsychological assessment. The subjects will do 3 tests about executive functions. The participants will complete 3 questionnaires about autism and 3 questionnaires about the self concept.

The subjects will perform Autobiographical memories assessment characteristics. The subjects will say the self statements which define them. Then, the participants will have to tell and specify the characteristics of the autobiographical memories linked to the self statements.

The subjects will perform clinical, psychological and neuropsychological assessment.The subjects will do 3 tests about executive functions. Finally, the participants will complete 3 questionnaires about autism and 3 questionnaires about the self concept.

The subjects will perform Autobiographical memories assessment characteristics. The subjects will say the self statements which define them. Then, the participants will have to tell and specify the characteristics of the autobiographical memories linked to the self statements

Outcomes

Primary Outcome Measures

The number of details in the memory (A)/The specificity of the memory (B)
study A:The number of details is the total number of perceptual/sensory, temporal, contextual, emotional and cognitive details found in the memory after spontaneous recall first. Secondly, the investigators will ask subjects to clarify the five characteristics of the details presented upper and retrieval should be make easier with specific cueing. Study B:The specificity measures how the memory is focused on specific date, space, context, emotions, thoughts and feelings. The specificity of the memories is deeply linked to the self .

Secondary Outcome Measures

Study A and B: Autistic symptoms questionnaire 1
Autistic symptoms are assessed through the Ritvo's Autism Asperger Diagnostic Scale. A numerical value will be obtained for this questionnaire.
Study A and B: Autistic symptoms questionnaire 2
Autistic symptoms are assessed through the Empathy Quotient. A numerical value will be obtained for this questionnaire.
Study A and B: Autistic symptoms questionnaire 3
Autistic symptoms are assessed through the Autistic Quotient. A numerical value will be obtained for this questionnaire.
Study A and B:Executives functions, test 1
Executive functions are measured through test: the Trail Making Test A & B, The test will provide value in seconds. This executive functions are known to be impaired in autism spectrum disorder and to be involved in autobiographical memory.
Study Aand B:Executives functions test 2
Executive functions are measured through test: The Hayling test . The tests will provide value in seconds. This executive functions are known to be impaired in autism spectrum disorder and to be involved in autobiographical memory.
Study A and B:Executives functions test 3
Executive functions are measured through test: The phonologic verbal fluency tasks. The test will give numerical value. These executive functions are known to be impaired in autism spectrum disorder and to be involved in autobiographical memory.
Study A and B: The self concept, questionnaire 1
The self-concept is measured through the questionnaire like the Thinking About Life Experiences (TALE) scale. This test measure how the self is updated and adaptable. A numerical value will be obtained for the questionnaire.
Study A and B: The self concept, questionnaire 2
The self-concept is measured through the questionnaire like: The Self Concept Clarity Scale. This test measure how the self is updated and adaptable. A numerical value will be obtained for the questionnaire.
Study A and B: The self concept, questionnaire 3
The self-concept is measured through the questionnaire like : The Rosenberg self-esteem test. This test measure how the self is updated and adaptable. A numerical value will be obtained for the questionnaire.
Study A: the number of remember/ know/ guess responses, the perspective in recollection and the subjective temporal distance in the memory
The number or remember, know, guess responses gives information about the subjective state of conscious awareness during the recall of the memory. This subjective state goes from complete conscious recollection with reliving of thoughts, perceptions, and feelings at the date of the event to a vague impression. The perspective in recollection could be an actor perspective or an observer perspective. In the actor perspective, the recollection is in a first-person point of view. The person remembering relives the event through her own eyes. In the observer perspective, the recollection is in a third-person point of view. The person remembering sees the scene of the memory as the spectator of herself. The subjective temporal distance is the subjective perception of the temporal distance between the present and the event of the memory. The investigators will ask subjects if they feel this event close or distant on a seven point scale.
Study B:The importance for the self of the memory test1
The importance for the self of the memory is assessed by distinctiveness. The distinctiveness criteria of the memory is established by Conway. These criteria require participants to specify in what extent these memories have had a personal significance, were discriminatory, consistent and are frequently recalled. A numerical value will be obtained for this criteria.
Study B:The importance for the self of the memory test 2
The importance for the self of the memory is assessed by emotional intensity. The emotional intensity will be measured with the PANAS scale. The investigator will ask the participants to rate the emotional intensity of their memory based on 4 positive affect (determined, enthusiastic, proud and strong) and 4 negative affect (frightened, ashamed, guilty and disappointed). No value is obtained.
Study B:The importance for the self of the memory test 3
The importance for the self of the memory is assessed by the active or passive position . An active position will refer to a memory in which the subject plays a key role in the progression of the event. A passive position will refer to a memory where the participant undergoes an event where he did not play a determining role.
Study B:The importance for the self of the memory test 4
The importance for the self of the memory is assessed by the emotional valence of memory. The emotional valence of memory will be etheir positive, negative or neutral.

Full Information

First Posted
March 7, 2016
Last Updated
August 19, 2019
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02747056
Brief Title
Study of the Personal Identity in Adults With Autism Spectrum Disorder Without Intellectual Deficiency
Acronym
TSASDI
Official Title
Study of the Personal Identity in Adults With Autism Spectrum Disorder Without Intellectual Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

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 research aims at clarifying the impact of autism on personal identity in adulthood. Two studies will be made in order to compare adults with autistic spectrum disorders without intellectual deficiency and controls. In the first study (Study A), the investigators will ask subjects to tell autobiographical memories and to specify their characteristics by answering focused questions. In the second study (Study B), the investigators will ask subjects to say the self statements which define them. Then, subjects will have to tell and to specify the characteristics of the autobiographical memories linked to these self statements.
Detailed Description
Introduction: Autism associates impairments in social relationships and specific competencies linked to restricted interests. These interests usually focus on mathematics, drawings or foreign language learning and are very significant in the autobiographies of persons with autism without intellectual deficiency. It's seem to be a basement of their self-identity. The personal identity relies on both the self representations and the sense of self. This sense of self supports the self continuity through time which links the present feelings, the autobiographical memories and the future personals projects. The personal identity depends on the memory of life events called "autobiographical memory." Objectives: The research aims at clarifying the impact of autism on personal identity in adulthood. Two studies will be made in order to compare adults with autistic spectrum disorders without intellectual deficiency and controls. In the first study (Study A), the investigators will ask subjects to tell autobiographical memories and to specify their characteristics by answering focused questions. In the second study (Study B), the investigators will ask subjects to say the self statements which define them. Then, subjects will have to tell and to specify the characteristics of the autobiographical memories linked to these self statements. Expected Results: The first study will inform the investigators on the sense of self and self continuity through time. The investigators predict that it would be difficult for subjects with autism spectrum disorders to give details of their life events. The focused questions should make easier the recollection of the memories. The investigators hypothesize that the memories linked to the typically autistic restricted interests would be more detailed. The second study will inform the investigators on the memories linked to self representations. The investigators predict that these memories would be, in autism, less detailed and less important for identity. The investigators also hypothesize that the memories linked to the restricted interests would be more detailed and important for the self. Autobiographical memory and socialization are deeply interconnected. So, the investigators think that this research will help them to elaborate news therapies focused on autobiographical memory improvement. Finally, the investigators want to reduce the social disability in autism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorders

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autism spectrum disorder studyA part1
Arm Type
Experimental
Arm Description
The subjects will perform clinical, psychological and neuropsychological assessment. the subjects will do 3 tests about executive functions. Finally, the participants will complete 3 questionnaires about autism and 3 questionnaires about the self concept.
Arm Title
Autism spectrum disorder studyA part2
Arm Type
Experimental
Arm Description
The subjects will perform Autobiographical memories Assessment. The subjects will tell autobiographical memories freely first and secondly by answering focused questions to specify the characteristics of subjects' memories
Arm Title
Control adults Study A, part 1
Arm Type
Other
Arm Description
The subjects will perform clinical, psychological and neuropsychological assessment. The subjects will do 3 tests about executive functions. The participants will complete 3 questionnaires about autism and 3 questionnaires about the self concept.
Arm Title
Control adults Study A, part 2
Arm Type
Other
Arm Description
The subjects will perform Autobiographical memories Assessment. The subjects will tell autobiographical memories freely first and secondly by answering focused questions to specify the characteristics of subjects' memories
Arm Title
Autism spectrum disorder Study B, part 1
Arm Type
Experimental
Arm Description
The subjects will perform clinical, psychological and neuropsychological assessment. The subjects will do 3 tests about executive functions. The participants will complete 3 questionnaires about autism and 3 questionnaires about the self concept.
Arm Title
Autism spectrum disorder Study B, part 2
Arm Type
Experimental
Arm Description
The subjects will perform Autobiographical memories assessment characteristics. The subjects will say the self statements which define them. Then, the participants will have to tell and specify the characteristics of the autobiographical memories linked to the self statements.
Arm Title
Control adults, Study B part 1
Arm Type
Other
Arm Description
The subjects will perform clinical, psychological and neuropsychological assessment.The subjects will do 3 tests about executive functions. Finally, the participants will complete 3 questionnaires about autism and 3 questionnaires about the self concept.
Arm Title
Control adults, Study B part 2
Arm Type
Other
Arm Description
The subjects will perform Autobiographical memories assessment characteristics. The subjects will say the self statements which define them. Then, the participants will have to tell and specify the characteristics of the autobiographical memories linked to the self statements
Intervention Type
Other
Intervention Name(s)
clinical, psychological and neuropsychological assessment
Intervention Description
the subjects will do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
Intervention Type
Other
Intervention Name(s)
Autobiographical memories Assessment
Intervention Description
The investigators will ask subjects to tell autobiographical memories freely first and, secondly, to specify participants'characteristics by answering focused questions.
Intervention Type
Other
Intervention Name(s)
Autobiographical memories assessment characteristics
Intervention Description
During the second time point, the investigators will ask subjects to say the self statements which define them. Then, subjects will have to tell and to specify the characteristics of the autobiographical memories linked to these self statements.
Primary Outcome Measure Information:
Title
The number of details in the memory (A)/The specificity of the memory (B)
Description
study A:The number of details is the total number of perceptual/sensory, temporal, contextual, emotional and cognitive details found in the memory after spontaneous recall first. Secondly, the investigators will ask subjects to clarify the five characteristics of the details presented upper and retrieval should be make easier with specific cueing. Study B:The specificity measures how the memory is focused on specific date, space, context, emotions, thoughts and feelings. The specificity of the memories is deeply linked to the self .
Time Frame
The number of details or the specificity of the memory is assessed from 1 day to 3 months after the inclusion/baseline
Secondary Outcome Measure Information:
Title
Study A and B: Autistic symptoms questionnaire 1
Description
Autistic symptoms are assessed through the Ritvo's Autism Asperger Diagnostic Scale. A numerical value will be obtained for this questionnaire.
Time Frame
the Autistic symptoms will be assessed during the initiation/baseline visit at V1
Title
Study A and B: Autistic symptoms questionnaire 2
Description
Autistic symptoms are assessed through the Empathy Quotient. A numerical value will be obtained for this questionnaire.
Time Frame
the Autistic symptoms will be assessed during the initiation/baseline visit at V1
Title
Study A and B: Autistic symptoms questionnaire 3
Description
Autistic symptoms are assessed through the Autistic Quotient. A numerical value will be obtained for this questionnaire.
Time Frame
the Autistic symptoms will be assessed during the initiation/baseline visit at V1
Title
Study A and B:Executives functions, test 1
Description
Executive functions are measured through test: the Trail Making Test A & B, The test will provide value in seconds. This executive functions are known to be impaired in autism spectrum disorder and to be involved in autobiographical memory.
Time Frame
Executives functions will be assessed during the initiation/baseline visit (V1)
Title
Study Aand B:Executives functions test 2
Description
Executive functions are measured through test: The Hayling test . The tests will provide value in seconds. This executive functions are known to be impaired in autism spectrum disorder and to be involved in autobiographical memory.
Time Frame
Executives functions will be assessed during the initiation/baseline visit (V1)
Title
Study A and B:Executives functions test 3
Description
Executive functions are measured through test: The phonologic verbal fluency tasks. The test will give numerical value. These executive functions are known to be impaired in autism spectrum disorder and to be involved in autobiographical memory.
Time Frame
Executives functions will be assessed during the initiation/baseline visit (V1)
Title
Study A and B: The self concept, questionnaire 1
Description
The self-concept is measured through the questionnaire like the Thinking About Life Experiences (TALE) scale. This test measure how the self is updated and adaptable. A numerical value will be obtained for the questionnaire.
Time Frame
self-concept will be assessed during the initiation/baseline visit (V1)
Title
Study A and B: The self concept, questionnaire 2
Description
The self-concept is measured through the questionnaire like: The Self Concept Clarity Scale. This test measure how the self is updated and adaptable. A numerical value will be obtained for the questionnaire.
Time Frame
self-concept will be assessed during the initiation/baseline visit (V1)
Title
Study A and B: The self concept, questionnaire 3
Description
The self-concept is measured through the questionnaire like : The Rosenberg self-esteem test. This test measure how the self is updated and adaptable. A numerical value will be obtained for the questionnaire.
Time Frame
self-concept will be assessed during the initiation/baseline visit (V1)
Title
Study A: the number of remember/ know/ guess responses, the perspective in recollection and the subjective temporal distance in the memory
Description
The number or remember, know, guess responses gives information about the subjective state of conscious awareness during the recall of the memory. This subjective state goes from complete conscious recollection with reliving of thoughts, perceptions, and feelings at the date of the event to a vague impression. The perspective in recollection could be an actor perspective or an observer perspective. In the actor perspective, the recollection is in a first-person point of view. The person remembering relives the event through her own eyes. In the observer perspective, the recollection is in a third-person point of view. The person remembering sees the scene of the memory as the spectator of herself. The subjective temporal distance is the subjective perception of the temporal distance between the present and the event of the memory. The investigators will ask subjects if they feel this event close or distant on a seven point scale.
Time Frame
This outcome will be assessed on the follow up visit (V2) either one day after the inclusion visit (V1) or within 3 months after V1
Title
Study B:The importance for the self of the memory test1
Description
The importance for the self of the memory is assessed by distinctiveness. The distinctiveness criteria of the memory is established by Conway. These criteria require participants to specify in what extent these memories have had a personal significance, were discriminatory, consistent and are frequently recalled. A numerical value will be obtained for this criteria.
Time Frame
This outcome will be assessed on the follow up visit (V2) either one day after the inclusion visit (V1) or within 3 months after V1Description
Title
Study B:The importance for the self of the memory test 2
Description
The importance for the self of the memory is assessed by emotional intensity. The emotional intensity will be measured with the PANAS scale. The investigator will ask the participants to rate the emotional intensity of their memory based on 4 positive affect (determined, enthusiastic, proud and strong) and 4 negative affect (frightened, ashamed, guilty and disappointed). No value is obtained.
Time Frame
this outcome will be assessed on the follow up visit (V2) either one day after the inclusion visit (V1) or within 3 months after V1Description
Title
Study B:The importance for the self of the memory test 3
Description
The importance for the self of the memory is assessed by the active or passive position . An active position will refer to a memory in which the subject plays a key role in the progression of the event. A passive position will refer to a memory where the participant undergoes an event where he did not play a determining role.
Time Frame
this outcome will be assessed on the follow up visit (V2) either one day after the inclusion visit (V1) or within 3 months after V1Description
Title
Study B:The importance for the self of the memory test 4
Description
The importance for the self of the memory is assessed by the emotional valence of memory. The emotional valence of memory will be etheir positive, negative or neutral.
Time Frame
this outcome will be assessed on the follow up visit (V2) either one day after the inclusion visit (V1) or within 3 months after V1Description

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Study A & B, Adults with autism spectrum disorders without intellectual deficiency Inclusion criteria: adults with autism spectrum disorders 18 to 65 years old Exclusion criteria: treatment with benzodiazepines Study A & B, control adults Inclusion criteria: healthy volunteers 18 to 65 years old Exclusion criteria: psychiatric disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Marie DANION, Prof
Organizational Affiliation
Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of the Personal Identity in Adults With Autism Spectrum Disorder Without Intellectual Deficiency

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