- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05886361
Somatiske symptomer ved autismespektrumforstyrrelse: dataintegration
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiesteder
-
-
-
Taipei, Taiwan
- National Taiwan University Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- ASD-gruppe: diagnosticeret med DSM-5 autismespektrumforstyrrelse
- klinisk gruppe: angst, depression, somatisk lidelse, som er ikke-psykotiske og ikke-organiske
- kontrolgruppe: sund kontrol uden psykiatrisk lidelse eller kroniske somatiske symptomer
- alder mellem 15 og 70
Ekskluderingskriterier:
- psykiatriske lidelser såsom skezofreni, stemningslidelse.
- alvorlig fysisk lidelse, som kan være potentielt dødelig
- som ikke kan læse eller forstå undersøgelsen og spørgeskemaet
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
ASD
Diagnosticeret med DSM-5 autismespektrumforstyrrelse
|
Ingen indgriben involveret
|
|
Klinisk
Patienter med angst, depression, somatiske symptomer, som er ikke-psykotiske og ikke-organiske
|
Ingen indgriben involveret
|
|
Styring
Sund kontrol uden psykiatrisk lidelse eller kroniske somatiske symptomer
|
Ingen indgriben involveret
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient health questionnaire-15, PHQ-15
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
range from 0 to 2 for each item, total score range from 0 to 30.
Higher the score, worse the level of somatization
|
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
|
Health assessment questionnaire, HAQ
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
range from 0 to 3 for each item.
Higher the score, worse the disability
|
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
|
Beck depression inventory, BDI
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
range from 0 to 3 for each item.
Higher the score, worse the depression
|
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
|
Beck anxiety inventory
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
range from 0 to 3 for each item.
Total score 0 to 63.
Higher the score, worse the anxiety
|
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
|
Tridimensional Personality Questionnaire (TPQ)
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
a 100-item, true/false psychological test, measures three neurotransmitter-linked personality dimensions:
|
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
|
WHO Quality of Life-BREF (WHOQOL-BREF)
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
a 26-item survey by the World Health Organization that measures personal well-being across four core domains: physical health, psychological health, social relationships, and environment.
Scores are scaled from 0 to 100, where higher numbers show a better quality of life.
|
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
|
Sensory profile
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
a standardized questionnaire completed by caregivers, teachers, or individuals to evaluate how a person processes everyday sensory information (like touch, sound, and movement). It measures how a person's nervous system responds to sensory inputs and how those responses affect daily life. Results describe an individual in the following four areas: Seeking: Actively searches for extra sensory input (e.g., loves spinning, crashing into things, chewing objects, or loud music). Sensitivity: Detects sensory input very quickly and easily, noticing small details (e.g., easily distracted by background noise or bright lights). Avoiding: Actively tries to escape or prevent sensory input (e.g., covers ears in loud rooms, refuses certain clothing textures, or avoids crowds). Low Registration: Misses or is slow to notice sensory input (e.g., doesn't respond to their name, seems clumsy, or doesn't notice pain/temperatures). |
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
|
Social responsiveness scale (SRS)
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
a 65-item questionnaire that measures the severity of social impairment and autism spectrum-related traits.
It evaluates how a person acts in real-life social settings.
Higher scores represent greater impairment.
|
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
|
Autism Spectrum Quotient (AQ)
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
The Autism Spectrum Quotient (AQ) is a 50-item self-report questionnaire used to measure autistic traits in adults and teens.
Scores range from 0 to 50.
A score of 26 or higher suggests elevated autistic traits, while 32 or higher indicates a strong presence of these traits.
|
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
|
Empathy Quotient (EQ)
Tidsramme: Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
The Empathy Quotient (EQ) is a self-report questionnaire developed by psychologist Simon Baron-Cohen to measure a person's ability to understand others' thoughts and feel appropriate emotional responses.
The standard test has 60 items (40 scored statements and 20 filler questions) spanning cognitive empathy, emotional reactivity, and social skills.
Higher scores indicate higher empathy levels.
|
Time of the original assessment (data collected retrospectively from January 1, 2014 to March 21, 2023)
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 202206027RINA
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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