Intervention for Toddlers at Risk for Autism Spectrum Disorders (ASD)
9 de marzo de 2021 actualizado por: Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
A Comprehensive Approach to Intervention for Toddlers at Risk for ASD
This research is being done to test the effectiveness of an early intervention model for very young children at high risk for autism spectrum disorders (ASD) and their families.
If children show improvement in this intervention, the investigators hope that the availability of public services of this type will be increased.
Children between 11 months and 21 months old with Autism Spectrum Disorders, or with social and communication delays that indicate high risk for Autism Spectrum Disorders, and their parents may join the study.
Treatment must start prior to the second birthday.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
49
Fase
- No aplica
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
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21211
- Kennedy Krieger Institute
-
-
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
11 meses a 1 año (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Children will be ascertained between 11 months and 21 months of age
- Must be able to enter the study prior to their second birthday
- Must then pass an eligibility assessment to determine whether the child meets criteria for ASD and thus qualifies for the study. This assessment will consist of the Baby ADOS and the Mullen Scales of Early Learning. Children must meet criteria for ASD or autism on the ADOS, score more than one standard deviation below the mean on the Receptive or Expressive Language scale of the MSEL, and have a clinical judgment of ASD to be eligible for enrollment into treatment.
- Parents must agree to participate in the study and commit to having their child participate in the intervention to which they are randomized for 6 months
- The parent (or other primary caregiver, such as grandparent) in the Parent Enrichment/Training condition must agree to attend the training sessions
Exclusion Criteria:
- Fail hearing or vision screening (by pediatrician's office, audiologist, or ophthalmologist)
- Family's first language being other than English (language measures are normed on English speakers, putting non-English speakers at a disadvantage. In addition, the treatment is delivered in English. Children from non-English speaking homes may not make progress, but for reasons other than the efficacy of the intervention.)
- Head injury (because this may cause some of the symptoms, which may not be due to autism and therefore we would not be able to assess the effects of the intervention on autism)
- Identified reason for the autism (e.g., fragile X syndrome, Rett syndrome, Tuberous Sclerosis)
- Inability of the family to attend the playgroup sessions and parent trainings
- Parents whose hearing or vision is not within normal limits after correction (e.g., hearing aid, glasses)
- Parents with developmental delays, language or learning impairments, or a psychiatric diagnosis IF the impairment would interfere with parent training (PI will assess on a case by case basis by talking to the parent)
- Foster children
- Refusal to allow videotaping of the children's assessments or intervention or to allow videotaped footage to be used for teaching purposes.
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Playgroup and Parent Training
|
The playgroup will be conducted at our center and focuses on providing an invigorating learning environment in which emerging skills/knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally.
Learning with and through peers, provides the opportunity to address abnormal peer relationships for developmental level.
Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children experiences that they would not otherwise have.
Parent training sessions will focus on strategies aimed at improving child social engagement and communication.
Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources.
The 1-2 hour individual therapeutic sessions with parent training in the home or clinic (1x every week over six months) are based on our own program which is in development.
This program focuses on teaching parents how to encourage social and communication skills in their toddlers and also provides comprehensive information about development.
Sessions will focus on knowledge of autism, current access to services, general knowledge of strategies used to facilitate child development, advocacy, knowledge of how to access services, and coping strategies.
Otros nombres:
In the once-a-week 1 to 2 hour parent training/enrichment, we will ask parents to target specific play and care routines in which they may stimulate their child's development in the ways identified by the therapist.
These stimulation times may be provided by the parents, other family members, friends, volunteers or hired assistants.
Parents will be encouraged to have their child in direct skill-enhancing engagement for 1-2 hour per day.
The therapist will work with the family to identify times during the day that best lend themselves to accomplishing this goal.
Otros nombres:
|
|
Comparador activo: Parent Training
|
The 1-2 hour individual therapeutic sessions with parent training in the home or clinic (1x every week over six months) are based on our own program which is in development.
This program focuses on teaching parents how to encourage social and communication skills in their toddlers and also provides comprehensive information about development.
Sessions will focus on knowledge of autism, current access to services, general knowledge of strategies used to facilitate child development, advocacy, knowledge of how to access services, and coping strategies.
Otros nombres:
In the once-a-week 1 to 2 hour parent training/enrichment, we will ask parents to target specific play and care routines in which they may stimulate their child's development in the ways identified by the therapist.
These stimulation times may be provided by the parents, other family members, friends, volunteers or hired assistants.
Parents will be encouraged to have their child in direct skill-enhancing engagement for 1-2 hour per day.
The therapist will work with the family to identify times during the day that best lend themselves to accomplishing this goal.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Developmental Level
Periodo de tiempo: 3 months into treatment, 6 months into treatment, and 6 months after treatment ends
|
Using the Mullen Scales of Early Learning to assess.
|
3 months into treatment, 6 months into treatment, and 6 months after treatment ends
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Communication
Periodo de tiempo: 3 months after treatment starts
|
Using Communication and Symbolic Behavior Scales to assess.
|
3 months after treatment starts
|
|
Communication
Periodo de tiempo: 6 months into treatment
|
Using Communication and Symbolic Behavior Scales to assess.
|
6 months into treatment
|
|
Communication
Periodo de tiempo: 6 months after treatment ends
|
Using Communication and Symbolic Behavior Scales to assess.
|
6 months after treatment ends
|
|
Presence and Severity of Autism
Periodo de tiempo: 3 months after treatment starts
|
Using Autism Diagnostic Observation Schedule to assess.
|
3 months after treatment starts
|
|
Presence and Severity of Autism
Periodo de tiempo: 6 months into treatment
|
Using Autism Diagnostic Observation Schedule to assess.
|
6 months into treatment
|
|
Presence and Severity of Autism
Periodo de tiempo: 6 months after treatment ends
|
Using Autism Diagnostic Observation Schedule to assess.
|
6 months after treatment ends
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Keen D, Rodger S, Doussin K, Braithwaite M. A pilot study of the effects of a social-pragmatic intervention on the communication and symbolic play of children with autism. Autism. 2007 Jan;11(1):63-71. doi: 10.1177/1362361307070901.
- Solomon R, Necheles J, Ferch C, Bruckman D. Pilot study of a parent training program for young children with autism: the PLAY Project Home Consultation program. Autism. 2007 May;11(3):205-24. doi: 10.1177/1362361307076842.
- Howlin P, Gordon RK, Pasco G, Wade A, Charman T. The effectiveness of Picture Exchange Communication System (PECS) training for teachers of children with autism: a pragmatic, group randomised controlled trial. J Child Psychol Psychiatry. 2007 May;48(5):473-81. doi: 10.1111/j.1469-7610.2006.01707.x.
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
1 de enero de 2008
Finalización primaria (Actual)
1 de diciembre de 2011
Finalización del estudio (Actual)
1 de diciembre de 2011
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2010
Primero enviado que cumplió con los criterios de control de calidad
10 de agosto de 2010
Publicado por primera vez (Estimar)
11 de agosto de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
9 de marzo de 2021
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NA_00006553
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. .