- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07582757
Joint Attention Processing in Social Threat Scenarios
The Proactive and Joint Attention Processing Characteristics of Children With Autism Induced by Social Threat Scenarios
Descripción general del estudio
Estado
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Sichuan
-
Chengdu, Sichuan, Porcelana, 611731
- School of Foreign Languages, University of Electronic Science and Technology of China
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
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.
Descripción
Inclusion Criteria:
-
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:
-
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Autism Spectrum Disorder (ASD) Group
|
|
Typically Developing Children (TD) Group
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Gaze transitions
Periodo de tiempo: The two time windows of 48-56 seconds and 70-80 seconds.
|
the number of transitions between face stimuli and unexpected stimuli
|
The two time windows of 48-56 seconds and 70-80 seconds.
|
|
The proportion of fixation time
Periodo de tiempo: The two time windows of 48-56 seconds and 70-80 seconds.
|
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
|
The two time windows of 48-56 seconds and 70-80 seconds.
|
|
Activation concentration
Periodo de tiempo: The two time windows of 48-56 seconds and 70-80 seconds.
|
the concentration of cortical activation during video viewing
|
The two time windows of 48-56 seconds and 70-80 seconds.
|
Colaboradores e Investigadores
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 (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UESTC-GazeLab-03
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .