- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02747056
Study of the Personal Identity in Adults With Autism Spectrum Disorder Without Intellectual Deficiency (TSASDI)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Strasbourg, Francia, 67091
- Hôpitaux Universitaires de Strasbourg
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Autism spectrum disorder studyA part1
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.
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the subjects will do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
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Experimental: Autism spectrum disorder studyA part2
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
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The investigators will ask subjects to tell autobiographical memories freely first and, secondly, to specify participants'characteristics by answering focused questions.
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Otro: Control adults Study A, part 1
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 do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
|
Otro: Control adults Study A, part 2
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 investigators will ask subjects to tell autobiographical memories freely first and, secondly, to specify participants'characteristics by answering focused questions.
|
Experimental: Autism spectrum disorder Study B, part 1
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 do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
|
Experimental: Autism spectrum disorder Study B, part 2
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.
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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.
|
Otro: Control adults, Study B part 1
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 do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
|
Otro: Control adults, Study B part 2
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
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
The number of details in the memory (A)/The specificity of the memory (B)
Periodo de tiempo: The number of details or the specificity of the memory is assessed from 1 day to 3 months after the inclusion/baseline
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Study A and B: Autistic symptoms questionnaire 1
Periodo de tiempo: the Autistic symptoms will be assessed during the initiation/baseline visit at V1
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Autistic symptoms are assessed through the Ritvo's Autism Asperger Diagnostic Scale.
A numerical value will be obtained for this questionnaire.
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the Autistic symptoms will be assessed during the initiation/baseline visit at V1
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Study A and B: Autistic symptoms questionnaire 2
Periodo de tiempo: the Autistic symptoms will be assessed during the initiation/baseline visit at V1
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Autistic symptoms are assessed through the Empathy Quotient.
A numerical value will be obtained for this questionnaire.
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the Autistic symptoms will be assessed during the initiation/baseline visit at V1
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Study A and B: Autistic symptoms questionnaire 3
Periodo de tiempo: the Autistic symptoms will be assessed during the initiation/baseline visit at V1
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Autistic symptoms are assessed through the Autistic Quotient.
A numerical value will be obtained for this questionnaire.
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the Autistic symptoms will be assessed during the initiation/baseline visit at V1
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Study A and B:Executives functions, test 1
Periodo de tiempo: Executives functions will be assessed during the initiation/baseline visit (V1)
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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.
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Executives functions will be assessed during the initiation/baseline visit (V1)
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Study Aand B:Executives functions test 2
Periodo de tiempo: Executives functions will be assessed during the initiation/baseline visit (V1)
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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.
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Executives functions will be assessed during the initiation/baseline visit (V1)
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Study A and B:Executives functions test 3
Periodo de tiempo: Executives functions will be assessed during the initiation/baseline visit (V1)
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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.
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Executives functions will be assessed during the initiation/baseline visit (V1)
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Study A and B: The self concept, questionnaire 1
Periodo de tiempo: self-concept will be assessed during the initiation/baseline visit (V1)
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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.
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self-concept will be assessed during the initiation/baseline visit (V1)
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Study A and B: The self concept, questionnaire 2
Periodo de tiempo: self-concept will be assessed during the initiation/baseline visit (V1)
|
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.
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self-concept will be assessed during the initiation/baseline visit (V1)
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Study A and B: The self concept, questionnaire 3
Periodo de tiempo: self-concept will be assessed during the initiation/baseline visit (V1)
|
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.
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self-concept will be assessed during the initiation/baseline visit (V1)
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Study A: the number of remember/ know/ guess responses, the perspective in recollection and the subjective temporal distance in the memory
Periodo de tiempo: 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
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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
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Study B:The importance for the self of the memory test1
Periodo de tiempo: 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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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.
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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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Study B:The importance for the self of the memory test 2
Periodo de tiempo: 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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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.
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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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Study B:The importance for the self of the memory test 3
Periodo de tiempo: 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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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.
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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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Study B:The importance for the self of the memory test 4
Periodo de tiempo: 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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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.
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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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jean Marie DANION, Prof, Hôpitaux Universitaires de Strasbourg
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 6282
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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