- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03333629
Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes
13 de febrero de 2023 actualizado por: Diana Robins, Drexel University
Connecting the Dots: An RCT Integrating Standardized ASD Screening, High-Quality Treatment, and Long-Term Outcomes
Autism spectrum disorder (ASD) is defined by impaired social engagement and social communication, and repetitive, restricted, or stereotyped behaviors and interests.
The average age of diagnosis in the US is after the fourth birthday.
However, children who start ASD-specific early intervention have better outcomes than children start later.
The current study will address a gap identified by the US Prevention Services Task Force, namely that children detected through screening respond positively to early intervention.
This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten.
Local pediatric providers will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures.
Across all sites, 8,000 children will be recruited through their participating pediatric practice.
Qualifying children will receive up to one year of early intensive behavioral intervention, after getting an ASD diagnosis.
Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points.
The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Autism spectrum disorder (ASD) is a serious neurodevelopmental disorder defined by impaired social engagement and social communication, in addition to the presence of repetitive, restricted, or stereotyped behaviors and interests.
Although many cases of ASD can be detected when children are less than two years old, the average age of diagnosis in the US is still after the fourth birthday.
However, evidence demonstrates that children who start ASD-specific early intervention have better outcomes than children who do not start treatment until later ages.
In 2006 and 2007, American Academy of Pediatrics recommended three early detection approaches to improve identification of children at risk for ASD: ongoing developmental surveillance at every well-child check-up, routine broad developmental screening at three infant/toddler ages, and ASD-specific screening at two toddler ages.
When these early detection strategies are used with all children attending well-child check-ups, the age of ASD detection is lower, and children who are diagnosed have the opportunity to start ASD-specific early intervention at younger ages than if they had not been detected.
Yet in 2016, the US Preventive Services Task Force (USPSTF) indicated that current evidence is insufficient to recommend universal ASD screening, given the lack of experimental studies demonstrating positive outcomes for treated children that are detected through screening.
The current study will address this gap.
This study will directly relate early detection strategies to early intervention, and measure the impact of age of intervention onset on outcomes when children are entering kindergarten.
The study will be conducted by investigators from three sites: Drexel University; the University of California, Davis; and the University of Connecticut.
Local pediatric providers will be enrolled in the study, and their practices will be randomized to provide either usual care, or to an experimental condition in which autism early detection strategies are enhanced through the addition of specific procedures.
Children attending well-child visits at participating practices will then be enrolled.
Across all sites, 8,000 children will be recruited through their participating pediatric practice.
As part of the study, qualifying children will receive up to one year of early intensive behavioral intervention, using an evidence-based manualized treatment.
Primary outcome measures will include children's cognitive functioning and ASD symptom severity, which will be measured at multiple time points.
Exploratory outcomes will include children's adaptive functioning, kindergarten readiness, and social reciprocity, as measured by experimental eye tracking and parent-child interaction ratings.
This study also will examine the impact of the screening intervention on physician attitudes and on parent empowerment and stress.
Finally, investigators will examine potential moderators of outcomes, to determine whether initial symptom severity, cognitive ability, or socioeconomic status affects children's long-term outcomes.
The investigators predict that this study will inform early detection strategies which will result in improving children's social and cognitive functioning, mitigating lifespan disability, reducing societal costs, and improving personal well-being and productivity of individuals with ASD.
Tipo de estudio
Intervencionista
Inscripción (Actual)
2087
Fase
- Fase 4
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
-
-
California
-
Sacramento, California, Estados Unidos, 95817
- University of California, Davis
-
-
Connecticut
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Storrs, Connecticut, Estados Unidos, 06269
- University of Connecticut
-
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Drexel University
-
-
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
1 año a 4 años (NIÑO)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- child attended 18 m visiting at participating pediatric practice
- legal guardian is fluent in English or Spanish
Exclusion Criteria:
- child has severe sensory or motor deficit that precludes completing standardized evaluation
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: PONER EN PANTALLA
- Asignación: ALEATORIZADO
- Modelo Intervencionista: PARALELO
- Enmascaramiento: DOBLE
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
EXPERIMENTAL: Enhanced early detection
Providers will receive training to administer enhanced early detection strategies.
|
standardized screening
|
SIN INTERVENCIÓN: Usual care
Providers will not change their early detection strategies, but will be monitored.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change in ASD Symptom Severity
Periodo de tiempo: Change from pre-treatment to immediately post-treatment; 10 minutes
|
ASD symptom severity will be measured with the Brief Observation of Social Communication Change (BOSCC)
|
Change from pre-treatment to immediately post-treatment; 10 minutes
|
Change in Cognitive Functioning
Periodo de tiempo: Change from pre-treatment to immediately post-treatment; 60 minutes
|
Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL).
|
Change from pre-treatment to immediately post-treatment; 60 minutes
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Adaptive Functioning
Periodo de tiempo: Immediately post-treatment, 48 m, 60 m; 45 minutes
|
Vineland Adaptive Behavior Scales-3
|
Immediately post-treatment, 48 m, 60 m; 45 minutes
|
Síntomas del TEA - medida secundaria1
Periodo de tiempo: 48m, 60m; 45 minutos
|
Programa de observación de diagnóstico de autismo, segunda edición (ADOS-2)
|
48m, 60m; 45 minutos
|
Kindergarten Readiness
Periodo de tiempo: 60 m; 45 minutes
|
Developmental Indicators for the Assessment of Learning-4
|
60 m; 45 minutes
|
Social Engagement
Periodo de tiempo: Immediately post-treatment, 48 m, 60 m; 15 minutes
|
Eye tracking paradigms will assess aspects of social engagement (i.e., social orienting, motivation, and cognition)
|
Immediately post-treatment, 48 m, 60 m; 15 minutes
|
Long-term change in Cognitive Functioning
Periodo de tiempo: 48 m, 60 m; 60 minutes
|
Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL)
|
48 m, 60 m; 60 minutes
|
Parent-Child Social Engagement
Periodo de tiempo: Immediately post-treatment, 48 m, 60 m; 15 minutes
|
Parent-child social engagement will be measured with the Joint Engagement Rating Inventory, which is applied to video recordings of the Communication Play Protocol.
|
Immediately post-treatment, 48 m, 60 m; 15 minutes
|
ASD symptoms - secondary measure2
Periodo de tiempo: Immediately post-treatment, 48 m, 60 m; 20 minutes
|
PDD Behavior Inventory
|
Immediately post-treatment, 48 m, 60 m; 20 minutes
|
ASD symptoms - secondary measure3
Periodo de tiempo: 48 m, 60 m; 10 minutes
|
BOSCC
|
48 m, 60 m; 10 minutes
|
Cambio a largo plazo en el funcionamiento cognitivo (alternativa)
Periodo de tiempo: 48m, 60m; 60 minutos
|
y para los niños que alcanzan el techo en el MSEL, usaremos las Escalas de Habilidades Diferenciales-II (DAS-II) para niños demasiado avanzados para el Resultado 7
|
48m, 60m; 60 minutos
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Diana Robins, PhD, Drexel University
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.
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)
29 de noviembre de 2017
Finalización primaria (ANTICIPADO)
30 de junio de 2023
Finalización del estudio (ANTICIPADO)
30 de junio de 2023
Fechas de registro del estudio
Enviado por primera vez
8 de septiembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
3 de noviembre de 2017
Publicado por primera vez (ACTUAL)
7 de noviembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (ESTIMAR)
14 de febrero de 2023
Última actualización enviada que cumplió con los criterios de control de calidad
13 de febrero de 2023
Última verificación
1 de febrero de 2023
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH115715 (NIH)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Data will be uploaded to the National Database for Autism Research (NDAR) semi-annually
Marco de tiempo para compartir IPD
semi-annual uploads beginning December 2018
Criterios de acceso compartido de IPD
as per NDAR requirements
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. .
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