Autism Spectrum Disorders Clinical Trial
— TSASDIOfficial title:
Study of the Personal Identity in Adults With Autism Spectrum Disorder Without Intellectual Deficiency
NCT number | NCT02747056 |
Other study ID # | 6282 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | August 2019 |
Verified date | August 2019 |
Source | University Hospital, Strasbourg, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 102 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpitaux universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 . |
The number of details or the specificity of the memory is assessed from 1 day to 3 months after the inclusion/baseline | |
Secondary | 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. | the Autistic symptoms will be assessed during the initiation/baseline visit at V1 | |
Secondary | 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. | the Autistic symptoms will be assessed during the initiation/baseline visit at V1 | |
Secondary | 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. | the Autistic symptoms will be assessed during the initiation/baseline visit at V1 | |
Secondary | 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. | Executives functions will be assessed during the initiation/baseline visit (V1) | |
Secondary | 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. | Executives functions will be assessed during the initiation/baseline visit (V1) | |
Secondary | 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. | Executives functions will be assessed during the initiation/baseline visit (V1) | |
Secondary | 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. | self-concept will be assessed during the initiation/baseline visit (V1) | |
Secondary | 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. | self-concept will be assessed during the initiation/baseline visit (V1) | |
Secondary | 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. | self-concept will be assessed during the initiation/baseline visit (V1) | |
Secondary | 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. |
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 | |
Secondary | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | 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. | 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 | |
Secondary | 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. | 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 |
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