- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03700190
The Predictors for Activity and Participation in Children With ASD: A Follow-up Study
17 de febrero de 2022 actualizado por: Chang Gung Memorial Hospital
Developmental Function and Participation in Life and School Activities in Patients With Autism Spectrum Disorder: A Follow-up Study
Developmental function and Participation in life and school activities in patients with autism spectrum disorder: A follow-up study
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Descripción detallada
Most ASD studies have explored the body functions and core symptoms in children with ASD by follow-up, but less studies explore the activities and participation by follow-up, especially the changes in different ages.
Although studies explore many predictors to predict the activities and participation in children with ASD, but less studies explore sensory perception to predict the activities and participation in children with ASD.
Tipo de estudio
De observación
Inscripción (Anticipado)
180
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Taoyuan, Taiwán, 333
- Reclutamiento
- Chang Gung Memorial Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
2 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
This study is a prospective and follow-up study.
Children with Autism Spectrum Disorder and Typical Developmental, aged 2-18 years.
Descripción
Inclusion Criteria:
- Patients with Autism Spectrum Disorder
- Age 2-18 y/o
- Agree to sign informed consent
Exclusion Criteria:
- Active medical condition (e.g. infection)
- Concurrent progressive or degenerative disease (e.g. neurogenerative disease)
- Concurrent illness or disease not typically associated with ASD (e.g. pneumonia)
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Control
Niño sano
|
|
Experimental
Patients with Autism Spectrum Disorder
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline of general developmental for Healthy child and patients with Autism Spectrum Disorder in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Comprehensive Developmental Inventory for Infants and Toddlers
|
baseline, 6 months, 12 months
|
|
Change from baseline of body function & structures in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Bruininks- Oseretsky Test of Motor Proficiency II short form
|
baseline, 6 months, 12 months
|
|
Change from baseline of Sensory and Perceptual function in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Sensory Profile:It is composed of 125 projects and is completed by the main caregivers of children.
There are 14 sub-projects, which can be divided into three main areas: sensory processing (6 items), adjustment (5 items), and emotional response ( 3 items), the project score is divided into 0, 25, 50, 75, 100% (none, rarely, occasionally, often, almost always)
|
baseline, 6 months, 12 months
|
|
Change from baseline of Participation in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Children Assessment of Participation and Enjoyment(CAPE): Applicable to children or adolescents between the ages of six and twenty one, through questionnaires through self-reports or interviews, a total of 49 questions, asking children about the activities involved in the past four months (1 point for yes, 0 for no).
|
baseline, 6 months, 12 months
|
|
Change from baseline of Participation in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Preferences for Activity of Children(APCP): For children between the ages of two and five, the questionnaire model is used to allow parents to circle the level.
There are 45 questions in total, so that the case or parent can review the activities in the past 4 months and ask if the child have done this activity (1 point means yes, 0 points means no).
|
baseline, 6 months, 12 months
|
|
Change from baseline of Visual Perception in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Test of Visual Perceptual Skills-Third Edition
|
baseline, 6 months, 12 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline of lower extremity function & structures in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Pediatric Balance Scale:The Pediatric Balance Scale (PBS) is a 14-item measure of functional balance for children, ages 2 to 13 years.
It was developed through modifications of the Berg Balance Scale to identify children who lack appropriate functional balance and thus may be at risk for developmental delay and injury.
The PBS is also used to identify change in functional balance with intervention.
The score for each item is from 0 (lowest function) to 4 (highest function).
The total maximum score that refers to the best function, is 56.
|
baseline, 6 months, 12 months
|
|
Change from baseline of activities in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Functional Independence Measure for Children:Applicable to infants and adolescents.
The main purpose is to understand and track children's life function performance, progress and goal achievement.
There are three main areas: self-care, mobility, and cognition.
The score is from 1 to 7 points, 1 is completely dependent, and 7 is completely independent.
|
baseline, 6 months, 12 months
|
|
Change from baseline of Quality of Life in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
TNO-AZL Child Quality of Life Questionnaire (TACQOL): The TACQOL is for children aged from 8 to 15.
The questionnaire can be done by the parents or the children themselves for children's health status.
The TACQOL contains 56 items with 7 domains (physical functioning, motor, autonomous, cognitive, social, positive moods, and negative moods).
There are 8 items in each domain.
For physical functioning, motor, autonomous, cognitive and social domains, the scoring is from 0 (never) to 3 (often), followed by a question of child's feeling (3: fine, 2: not so good, 1: quite bad or 0: bad).
Items are scored by assigning a value of 4 to the 'never' response, a value of 3 to a 'feeling fine' response, a value of 2 to a 'feeling not so good' response, a value of 1 to a 'feeling quite bad' response and a value of 0 to a 'feeling bad' response.
For moods, the scoring is from 0 (never) to 3 (often).
The minimal score is 0, and the maximal score is 219.
|
baseline, 6 months, 12 months
|
|
Change from baseline of Personal & Environment factor in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Parenting Stress Index:Screening and triage measure for evaluating the parenting system and identifying issues that may lead to problems in the child's or parent's behavior.
Focuses on three major domains of stress: child characteristics, parent characteristics and situational/demographic life stress.
|
baseline, 6 months, 12 months
|
|
Change from baseline of Rehabilitation & community service factor in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Measure of Processes of Care: It is to assess parents' perceptions of the care they and their children receive from children's rehabilitation treatment centers.
It is a means to assess family-centered behaviors of health care providers.
There are 20 items.
For each item, a question begins with "To what extent do the people who work with your child," with a 7-point scale with the statement "the service provider engaged in this behavior to a very great extent" (7 point) and "not at all" (1 point).
0 point refers to "not applicable.
For each item, the minimal score is 0, and the maximum is 7.
A scale score is obtained by calculating the average of the items' ratings.
There is no total score.
|
baseline, 6 months, 12 months
|
|
Change from baseline of Social Responsiveness Scale in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
his scale is suitable for children aged 4-18.
It is evaluated by 65 questions whether there is a social disorder.
The child is identified as autism.
The score is 0-3, 0 is untrue, and 3 is descriptive.
|
baseline, 6 months, 12 months
|
|
Change from baseline of facial expression in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Taiwanese facial expression database:According to Yangming University database, select black and white pictures, strong expression versions, and select five questions of happiness, anger, sadness, fear, and neutrality, a total of 20 questions, each question is taken in four ways, each emotion is in each question will only appear at most, and will be randomly distributed and presented on the computer.
The child will specify the specified mood, 1 point for each question, up to 20 points.
|
baseline, 6 months, 12 months
|
|
Change from baseline of Clancy Behavior Scale in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
This scale is suitable for children aged 2-5, a total of 14 questionnaires, about 10 minutes of test, mainly used to screen children with autism, three-point scoring, 2 points for frequent, 1 for occasional, 0 for No, the total score is greater than 14 and there is a tendency to autism.
If the score is more than 2/3, it is established as a child with autism.
|
baseline, 6 months, 12 months
|
|
Change from baseline of Theory of Mind Inventory-2 in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
A questionnaire for assessing children's social cognition ability, which is a five-point questionnaire for continuity.
It can be filled out by parents or filled by children with good reading skills and speaking skills.
This scale is suitable for children aged 2-13, including 60 items.
Each question is described as a state, including emotional cognition, mental state understanding, pragmatics and other fields.
The person who fills the document is marked with "not", "may not "undetermined", "may have", "determined"
|
baseline, 6 months, 12 months
|
|
Change from baseline of Childhood Autism Rating Scale II in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
Applicable to children under the age of six and those with insufficient intelligence or suspected communication at the age of six, used to judge whether children have autism.
A total of 15 questions, each topic is divided into 1 to 4 points, the highest total score of 60 points.
For high-function groups, the total score <27.5, non-autistic; between 28 and 33.5 points, there is a tendency to autism; >33.5 points, there is autism.
|
baseline, 6 months, 12 months
|
|
Change from baseline of Childhood Asperger Syndrome Test in 6 months and 12 months
Periodo de tiempo: baseline, 6 months, 12 months
|
This is a set of questionnaires for screening autism traits (social impairment, communication deficit, repetitive behavior) for children with Asperger or high-functioning autism.
It is suitable for children aged 4-11 years.
The questionnaire is filled out by parents and filled out.
The time is about 10 minutes, divided into two points (0, 1 points), a total of 37 questions
|
baseline, 6 months, 12 months
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de agosto de 2017
Finalización primaria (Anticipado)
31 de julio de 2022
Finalización del estudio (Anticipado)
31 de octubre de 2022
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
8 de octubre de 2018
Publicado por primera vez (Actual)
9 de octubre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de febrero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
17 de febrero de 2022
Última verificación
1 de febrero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 201601949B0
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .