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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

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
      • Storrs, Connecticut, Estados Unidos, 06269
        • University of Connecticut
    • Pennsylvania
      • 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

Otros números de identificación del estudio

  • R01MH115715 (NIH)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

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. .

Ensayos clínicos sobre Enhanced early detection

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