- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07582757
Joint Attention Processing in Social Threat Scenarios
The Proactive and Joint Attention Processing Characteristics of Children With Autism Induced by Social Threat Scenarios
Studienübersicht
Status
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Sichuan
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Chengdu, Sichuan, China, 611731
- School of Foreign Languages, University of Electronic Science and Technology of China
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Population composition: TD and ASD. TD: 3-10 years old, with normal vision and corrected vision, hearing, and no social or behavioral problems. ASD: 3-10 years old, diagnosed by a doctor with ASD, normal vision and corrected vision, hearing, etc., but with social and behavioral problems.
Key demographic information: 3-10 years old. TD: 22 males and 6 females. ASD: 24 males and 4 females.
Source and final scale: TD recruited 36 children from Jinhua Primary School and First Kindergarten in Shehong City, Sichuan Province, and ultimately used 28 children. ASD: 52 children from special schools and rehabilitation institutions in some districts and counties of Chengdu were recruited, and 28 were ultimately used.
Beschreibung
Inclusion Criteria:
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For ASD group:
- 3 years ≤ age ≤ 10 years;
- a diagnosis of autism spectrum disorder based on clinical symptoms, confirmed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and other auxiliary diagnostic scales, including the Autism Diagnostic Interview-Revised (ADI-R) and the Childhood Autism Rating Scale (CARS);
- further confirmation of ASD symptoms by experimenters with established research reliability using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2), with severity scores reported;
- absence of comorbid physical diseases or other psychiatric disorders, including normal vision (or corrected-to-normal vision) and normal hearing;
- no receipt of medication, transcranial magnetic stimulation (TMS), or transcranial direct current stimulation (tDCS) within the past three months.
For TD group:The inclusion criterion for the TD group was a score below the cutoff on the Social Responsiveness Scale (SRS).
Exclusion Criteria:
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For ASD group:
- age < 3 years or > 10 years;
- absence of a diagnosis of autism spectrum disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and other auxiliary diagnostic scales, including the Autism Diagnostic Interview-Revised (ADI-R) and the Childhood Autism Rating Scale (CARS);
- failure to meet diagnostic criteria after confirmation of ASD symptoms by experimenters with established research reliability using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2);
- presence of comorbid physical diseases or other psychiatric disorders, or problems with vision (or corrected-to-normal vision) and hearing;
- receipt of medication, transcranial magnetic stimulation (TMS), or transcranial direct current stimulation (tDCS) within the past three months.
For TD group:
children were excluded if their scores on the Social Responsiveness Scale (SRS) exceeded the cutoff.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Autism Spectrum Disorder (ASD) Group
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Typically Developing Children (TD) Group
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Gaze transitions
Zeitfenster: The two time windows of 48-56 seconds and 70-80 seconds.
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the number of transitions between face stimuli and unexpected stimuli
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The two time windows of 48-56 seconds and 70-80 seconds.
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The proportion of fixation time
Zeitfenster: The two time windows of 48-56 seconds and 70-80 seconds.
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The proportion of fixation time on AOI is calculated as the fixation time on AOI divided by the total valid fixation time on the screen within each phase
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The two time windows of 48-56 seconds and 70-80 seconds.
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Activation concentration
Zeitfenster: The two time windows of 48-56 seconds and 70-80 seconds.
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the concentration of cortical activation during video viewing
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The two time windows of 48-56 seconds and 70-80 seconds.
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Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- UESTC-GazeLab-03
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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