Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

19. august 2019 oppdatert av: University Hospital, Strasbourg, France
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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

102

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Strasbourg, Frankrike, 67091
        • Hôpitaux Universitaires de Strasbourg

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: clinical, psychological and neuropsychological assessment
the subjects will do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
Eksperimentell: 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
Annen: Autobiographical memories Assessment
The investigators will ask subjects to tell autobiographical memories freely first and, secondly, to specify participants'characteristics by answering focused questions.
Annen: 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.
Annen: clinical, psychological and neuropsychological assessment
the subjects will do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
Annen: 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
Annen: Autobiographical memories Assessment
The investigators will ask subjects to tell autobiographical memories freely first and, secondly, to specify participants'characteristics by answering focused questions.
Eksperimentell: 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.
Annen: clinical, psychological and neuropsychological assessment
the subjects will do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
Eksperimentell: 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.
Annen: Autobiographical memories assessment characteristics
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.
Annen: 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.
Annen: clinical, psychological and neuropsychological assessment
the subjects will do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
Annen: 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
Annen: Autobiographical memories assessment characteristics
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The number of details in the memory (A)/The specificity of the memory (B)
Tidsramme: The number of details or the specificity of the memory is assessed from 1 day to 3 months after the inclusion/baseline

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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Study A and B: Autistic symptoms questionnaire 1
Tidsramme: the Autistic symptoms will be assessed during the initiation/baseline visit at V1
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
Study A and B: Autistic symptoms questionnaire 2
Tidsramme: the Autistic symptoms will be assessed during the initiation/baseline visit at V1
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
Study A and B: Autistic symptoms questionnaire 3
Tidsramme: the Autistic symptoms will be assessed during the initiation/baseline visit at V1
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
Study A and B:Executives functions, test 1
Tidsramme: Executives functions will be assessed during the initiation/baseline visit (V1)
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)
Study Aand B:Executives functions test 2
Tidsramme: Executives functions will be assessed during the initiation/baseline visit (V1)
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)
Study A and B:Executives functions test 3
Tidsramme: Executives functions will be assessed during the initiation/baseline visit (V1)
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)
Study A and B: The self concept, questionnaire 1
Tidsramme: self-concept will be assessed during the initiation/baseline visit (V1)
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)
Study A and B: The self concept, questionnaire 2
Tidsramme: 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.
self-concept will be assessed during the initiation/baseline visit (V1)
Study A and B: The self concept, questionnaire 3
Tidsramme: 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.
self-concept will be assessed during the initiation/baseline visit (V1)
Study A: the number of remember/ know/ guess responses, the perspective in recollection and the subjective temporal distance in the memory
Tidsramme: 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

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
Study B:The importance for the self of the memory test1
Tidsramme: 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
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
Study B:The importance for the self of the memory test 2
Tidsramme: 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
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
Study B:The importance for the self of the memory test 3
Tidsramme: 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
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
Study B:The importance for the self of the memory test 4
Tidsramme: 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
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Strasbourg, France

Etterforskere

  • Hovedetterforsker: Jean Marie DANION, Prof, Hôpitaux Universitaires de Strasbourg

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juni 2016

Primær fullføring (Faktiske)

1. august 2019

Studiet fullført (Faktiske)

1. august 2019

Datoer for studieregistrering

Først innsendt

7. mars 2016

Først innsendt som oppfylte QC-kriteriene

18. april 2016

Først lagt ut (Anslag)

21. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. august 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. august 2019

Sist bekreftet

1. august 2019

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 6282

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Autismespekterforstyrrelser

Kliniske studier på clinical, psychological and neuropsychological assessment

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Senegal

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

3
Abonnere