School-Age Children With Autism With Limited Expressive Language Skills
9 de marzo de 2021 actualizado por: Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
School-Age Children With Autism With Limited Expressive Language Skills: An Intervention Study
This project will address a major challenge to the field of autism research: improving expressive communication in children with autism who have reached school age but have not acquired functional spoken language (non-verbal school aged children with autism; NVSACA).
Fifteen children who completed the RO1 ICAN intervention (NCT01018407) at the Kennedy Krieger site and follow-up testing but continue to have minimal functional spoken language will be participants in this study. After eligibility is established, participants will be randomly assigned to a baseline duration of one week, two weeks or three weeks before the start of active treatment. Once the baseline duration is completed, participants begin active treatment one hour of intervention three days per week in the participants' school setting. In month 2, weekly teacher trainings begin. In month 5, weekly parent trainings begin to improve the child's generalization of skills and teach parents the strategies implemented in their child's treatment. Post-baseline and post-treatment assessments will be completed in the lab at a time that is convenient for the participants' families.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
13
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
4 años a 7 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of autism by a licensed psychologist or board certified developmental pediatrician, or child and adolescent psychiatrist, confirmed by the Autism Diagnostic Observation Schedule (ADOS; Lord, Rutter, DiLavore, & Risi, 1999)
- Chronological age between 4.0 years and 7 years, 11 months
- Reynell developmental score ≤ 24 months, ADOS A1 score of 2, 3 or 8
- Nonverbal IQ of ≥ 40 (Leiter International Performance Scale-Revised (Leiter-R), Roid & Miller, 2007)
- Children have participated in and completed follow-up testing for the ICAN study.
Exclusion Criteria:
- Major medical conditions other than autism (e.g., genetic disorders [e.g., Fragile X, Down syndrome, tuberous sclerosis], blindness or deafness, and motor disabilities such as cerebral palsy;
- Uncontrolled seizures;
- Self-injurious behavior or moderate to severe aggression.
- Children in foster care.
- Children who are exposed to < 50% English throughout their typical day.
- Children currently participating in another intervention/treatment study.
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 de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 1 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 1 week before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
|
|
Experimental: 2 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 2 weeks before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
|
|
Experimental: 3 Week Basline Prior to Intervention
If eligible, you will be randomly assigned- as if by flipping a coin- to one of three baseline durations, during which your child will engage in daily interactions with their interventionist to determine if skills targeted by this intervention are improving naturally as your child matures, without active treatment from the study's interventionist.
In this case, the duration is 3 weeks before your child begins active treatment with their interventionist.
|
The intervention has 3 components:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Baseline Spontaneous Language
Periodo de tiempo: Weekly throughout the 5 month intervention (baseline and 5 months)
|
The number of unprompted spontaneous language during a 15min play sample.
|
Weekly throughout the 5 month intervention (baseline and 5 months)
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change in Baseline Autism Diagnostic Observation Schedule
Periodo de tiempo: 5 months into treatment (at completion of intervention)
|
5 months into treatment (at completion of intervention)
|
|
Change in Baseline Reynell
Periodo de tiempo: 5 months into treatment (at completion of intervention)
|
5 months into treatment (at completion of intervention)
|
|
Changes in Baseline Early Social Communication Scales (ESCS)
Periodo de tiempo: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
|
5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
|
|
Changes in Baseline Structured Play Assessment
Periodo de tiempo: 5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
|
5 months into treatment (at completion of intervention) and 6 months following the completion of the intervention
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
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 2012
Finalización primaria (Actual)
1 de diciembre de 2013
Finalización del estudio (Actual)
1 de diciembre de 2013
Fechas de registro del estudio
Enviado por primera vez
6 de febrero de 2012
Primero enviado que cumplió con los criterios de control de calidad
8 de febrero de 2012
Publicado por primera vez (Estimar)
9 de febrero de 2012
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_00049467
- 3R01MH085048-03S1 (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. .