- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02235467
Multisite Study: Parental Training Using Video Modelling to Develop Social Skills in Children With Autism
Multisite Study: Acquisition of Social Skills in Children With Autism Using Video Modeling in Parental Training
This is a Brazilian multisite study to test the efficacy of an Applied Behavior Analysis (ABA) parent training using video modeling to teach parents of children with Autism techniques to apply to their children in order to improve eye contact and joint attention behaviors.
Our hypothesis is that children with Autism whose parents will be trained by videomodeling will have better eye contact and joint attention behaviors compared to children with Autism whose parents will not be trained.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Applied Behavior Analysis (ABA) is an intervention with proven efficacy in treating impairments on social functioning and daily-life activities of individuals with Autism Spectrum Disorder (ASD). In Brazil we have a limited number of qualified professionals and an increasing demand of families non-served in the public health system.
Our main objective is to standardize and test the efficacy of a model for parent training using video modeling for teaching eye contact and joint attention behaviors in children with ASD. These two behaviors are essential to develop adequate social interaction, the core impaired domain in ASD. It is a multisite study to be carried out at the Universidade Federal de São Paulo, Universidade de São Paulo and Universidade Presbiteriana Mackenzie. The sample will be composed of 70 children divided in control and intervention groups that will be randomly chosen. The intervention should be carried out in 21 weeks.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
São Paulo, Brasil, 04038-030
- Federal University of São Paulo Department of Psychiatry
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Clinical Diagnosis of Autism Spectrum Disorders
- Diagnosis of Autism Spectrum Disorders by means of ADI
- IQ equal or lower than 70 by means of SON
- Main caregiver's level of education > primary education
Exclusion Criteria:
- IQ lower than 50 by means of SON
- Child who is receiving ABA therapy at least 10 hours per week
- Main caregiver diagnosed with Autism Spectrum Disorders
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: ABA parent training
Applied Behavior Analysis parent training using videomodeling in 21 sessions
|
A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
Otros nombres:
|
Sin intervención: ABA parent training control
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Acquisition from baseline of new behaviors at 8 weeks
Periodo de tiempo: baseline assessment to 8 weeks of therapy
|
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
|
baseline assessment to 8 weeks of therapy
|
Acquisition from baseline of new behaviors at 16 weeks
Periodo de tiempo: baseline assessment to 16 weeks
|
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
|
baseline assessment to 16 weeks
|
Acquisition from baseline of new behaviors at 21 weeks
Periodo de tiempo: baseline to 21 weeks
|
acquisition of new behaviors (eye contact and joint attention) checked through taped interactions between child and a family member
|
baseline to 21 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in Eye-tracking at 21 weeks
Periodo de tiempo: baseline assessment to 21 weeks
|
Latency, duration, and sequence of visual fixations measured with eye-tracking
|
baseline assessment to 21 weeks
|
Change from baseline in Vineland Scale at 21 weeks
Periodo de tiempo: baseline assessment to 21 weeks
|
Adaptative behavior using Vineland Scale
|
baseline assessment to 21 weeks
|
Change from baseline in SON-R 2½-7 at 21 weeks
Periodo de tiempo: baseline assessment to 21 weeks
|
Improve on SON-R 2½-7 that is an intelligence coefficient test developed for deaf people
|
baseline assessment to 21 weeks
|
Change from baseline in Zaritt Burden Interview at 21 weeks
Periodo de tiempo: baseline assessment to 21 weeks
|
The Zaritt Burden Interview measures the caregiver burden of taking care of the relative with psychiatric disorder
|
baseline assessment to 21 weeks
|
Change from baseline in OERA at 21 weeks
Periodo de tiempo: baseline assessment to 21 weeks
|
OERA (Observação Estruturada para Rastreamento de Autismo) is a taped structured observation to screen Autism that was developed by Brazilian researchers.
|
baseline assessment to 21 weeks
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline in KAP at 21 weeks
Periodo de tiempo: baseline assessment to 21 weeks
|
Improvement on the knowledge, attitude and practice (KAP) questionnaire
|
baseline assessment to 21 weeks
|
Change from baseline in Hamilton scalels and at 21 weeks
Periodo de tiempo: baseline assessment to 21 weeks
|
Improvement on the Hamilton Depression and Anxiety scales of the caregiver
|
baseline assessment to 21 weeks
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Sheila C Caetano, MD, PhD, Federal University of São Paulo, São Paulo, Brazil
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- U1111-1157-8984
- 2012/51584-0 (Otro número de subvención/financiamiento: FAPESP)
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. .
Ensayos clínicos sobre ABA parent training
-
The First Affiliated Hospital of Anhui Medical...Hefei Kanghua Rehabilitation Hospital; Hefei Jingu Rehabilitation HospitalAún no reclutando
-
Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
-
The Cleveland ClinicCVS Caremark; O'Neill FoundationTerminadoAutismoEstados Unidos
-
Montera Health Texas LLCAún no reclutandoDesorden del espectro autista
-
Johns Hopkins Bloomberg School of Public HealthInnovations for Poverty Action; Investors Club/Enterprise UgandaReclutamientoEstrés | Bienestar Psicológico | Dificultad económicaUganda
-
Hugo W. Moser Research Institute at Kennedy Krieger...ReclutamientoSíndrome de Cornelia de LangeEstados Unidos
-
Experiad LLCnorthwest behavioral associatesDesconocidoDesorden del espectro autistaEstados Unidos
-
Rigshospitalet, DenmarkUniversity of CopenhagenTerminadoResultado de aprendizaje | Eficiencia de entrenamientoDinamarca
-
Queen's UniversityTerminadoEficacia del Cuaderno de Recuperación como Herramienta Psicoeducativa para Facilitar la RecuperaciónDesordenes mentalesCanadá