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Promoting Positive Outcomes for Individuals With ASD: Linking Early Detection, Treatment, and Long-term Outcomes

13 février 2023 mis à jour par: 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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

2087

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • California
      • Sacramento, California, États-Unis, 95817
        • University of California, Davis
    • Connecticut
      • Storrs, Connecticut, États-Unis, 06269
        • University of Connecticut
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19104
        • Drexel University

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

1 an à 4 ans (ENFANT)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: DÉPISTAGE
  • Répartition: ALÉATOIRE
  • Modèle interventionnel: PARALLÈLE
  • Masquage: DOUBLE

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
EXPÉRIMENTAL: Enhanced early detection
Providers will receive training to administer enhanced early detection strategies.
standardized screening
AUCUNE_INTERVENTION: Usual care
Providers will not change their early detection strategies, but will be monitored.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in ASD Symptom Severity
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Adaptive Functioning
Délai: Immediately post-treatment, 48 m, 60 m; 45 minutes
Vineland Adaptive Behavior Scales-3
Immediately post-treatment, 48 m, 60 m; 45 minutes
Symptômes de TSA - mesure secondaire1
Délai: 48m, 60m; 45 minutes
Calendrier d'observation diagnostique de l'autisme, deuxième édition (ADOS-2)
48m, 60m; 45 minutes
Kindergarten Readiness
Délai: 60 m; 45 minutes
Developmental Indicators for the Assessment of Learning-4
60 m; 45 minutes
Social Engagement
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 48 m, 60 m; 10 minutes
BOSCC
48 m, 60 m; 10 minutes
Changement à long terme du fonctionnement cognitif (alternative)
Délai: 48m, 60m; 60 minutes
et pour les enfants qui atteignent le plafond du MSEL, nous utiliserons les échelles d'aptitudes différentielles différentielles-II (DAS-II) seront utilisées pour les enfants trop avancés pour le résultat 7
48m, 60m; 60 minutes

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Diana Robins, PhD, Drexel University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (RÉEL)

29 novembre 2017

Achèvement primaire (ANTICIPÉ)

30 juin 2023

Achèvement de l'étude (ANTICIPÉ)

30 juin 2023

Dates d'inscription aux études

Première soumission

8 septembre 2017

Première soumission répondant aux critères de contrôle qualité

3 novembre 2017

Première publication (RÉEL)

7 novembre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (ESTIMATION)

14 février 2023

Dernière mise à jour soumise répondant aux critères de contrôle qualité

13 février 2023

Dernière vérification

1 février 2023

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Data will be uploaded to the National Database for Autism Research (NDAR) semi-annually

Délai de partage IPD

semi-annual uploads beginning December 2018

Critères d'accès au partage IPD

as per NDAR requirements

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Enhanced early detection

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