- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02184390
Parenting Your Young Child With Autism: A Web-Based Tutorial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Autism is a neurodevelopmental disorder characterized by core deficits in social reciprocity, verbal and nonverbal communication, and behavior. Early detection and intervention has been shown to improve these core deficits, resulting in better long-term outcomes in language functioning, cognitive/developmental skills, and social and adaptive behavior. Despite the demonstrated benefits of effective intervention, few children receive these specialized services, due in part to critical resource barriers, such as the shortage of specialists trained to deliver them. The broad, long-term objective of this project is to improve outcomes for children with autism and their families by empowering caregivers with the knowledge and skills needed to effectively intervene directly with their children as part of their daily interactions and routines. By targeting those with the most invested in the child's success and the longest lasting influence on a child's long-term growth and development, we can help parents in several ways: a) teach parents how to promote their child's development in the core deficit areas seen in young children with autism spectrum disorders: social interaction, communication, play, and imitation; b) help parents understand and improve challenging behaviors their child may demonstrate, and c) reduce caregiver stress through more effective interactions.
To make this training widely accessible to parents of children with autism, we will deliver this training through a web-based, multi-media, interactive tutorial. The tutorial will use principles of instructional design to more effectively deliver the material and utilize high levels of interactivity afforded by the web-based platform to maximize learning. The tutorial teaches skills to improve their child's behavior and communication within the framework of everyday routines and activities, utilizing interactive exercises and a comprehensive set of videos of real parents implementing these strategies with their children within the context of everyday situations.
The specific aims of the proposed Phase II study are:
Aim 1. To evaluate parents' satisfaction and acceptance of the tutorial program Aim 2. To demonstrate the tutorial increases parental knowledge of the principles and techniques for improving effective parenting of children with Autism Spectrum Disorder.
Aim 3. To demonstrate behavioral improvements in actual parenting skills during the daily interactions with their child based on the knowledge gained.
Aim 4. To demonstrate that the improved parenting skills result in social, communication, and behavioral improvements in the children of parents who complete the tutorial.
Aim 5. To demonstrate that improving parenting skills through the use of this web-based tutorial program reduces caregiver stress and depression.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53717
- Center for Psychological Consulation
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- parents or caregivers of children with ASD between the ages of 18 months and 6 years with an autism spectrum disorder
Exclusion Criteria:
- Ability to read and understand English
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: tutorial
Parents who receive access to the tutorial immediately
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Interactive on line tutorial for parenting skills for autism
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Sin intervención: wait list control
Parents who are assessed at the same time points as the intervention arm, but do no receive access to the tutorial
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
System Usability Scale
Periodo de tiempo: 8 weeks
|
User satisfaction with the technical aspects of the Enhancing Interactions tutorial will be assessed using the ratings on the System Usability Scale (SUS).
The SUS is a reliable, well-validated 10-item scale 1,49 designed to evaluate the usability and user satisfaction with web-based applications and other technologies.
It yields quantitative feedback on a 0-100 scale regarding the effectiveness, efficiency, and satisfaction of users while interacting with engineered systems.
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8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Autism Knowledge Test
Periodo de tiempo: 8 weeks
|
Gains in parents' knowledge regarding of the principles and techniques for more effective parenting of children will be demonstrated using a pre and post test of 24-items developed by the content experts (Drs.
Stone and Warren, and Lisa Wallace) that covers the core concepts of the tutorials.
The test items were piloted in parents who (a) had received face-to-face training during Enhancing Interactions seminars and (b) other parents prior to being trained.
Items were selected based on their psychometric properties and sensitivity to discriminate between parents who had and had not been exposed to the Enhancing Interactions training.
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8 weeks
|
Otras medidas de resultado
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The Parent Interview for Autism-Clinical Version
Periodo de tiempo: 8 weeks
|
8 weeks
|
|
Parenting Efficacy Scale
Periodo de tiempo: 8 weeks
|
8 weeks
|
|
Parenting Stress Index
Periodo de tiempo: 8 weeks
|
8 weeks
|
|
Child and Parent Behavior Form
Periodo de tiempo: 8 weeks
|
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 5R44MH086936 (Subvención/contrato del NIH 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. .