- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03333629
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
Les conditions
Intervention / Traitement
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
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California
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Sacramento, California, États-Unis, 95817
- University of California, Davis
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Connecticut
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Storrs, Connecticut, États-Unis, 06269
- University of Connecticut
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- Drexel University
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-
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.
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standardized screening
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AUCUNE_INTERVENTION: Usual care
Providers will not change their early detection strategies, but will be monitored.
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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)
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Change from pre-treatment to immediately post-treatment; 10 minutes
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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).
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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
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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)
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48m, 60m; 45 minutes
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Kindergarten Readiness
Délai: 60 m; 45 minutes
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Developmental Indicators for the Assessment of Learning-4
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60 m; 45 minutes
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Social Engagement
Délai: Immediately post-treatment, 48 m, 60 m; 15 minutes
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Eye tracking paradigms will assess aspects of social engagement (i.e., social orienting, motivation, and cognition)
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Immediately post-treatment, 48 m, 60 m; 15 minutes
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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)
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48 m, 60 m; 60 minutes
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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
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ASD symptoms - secondary measure2
Délai: Immediately post-treatment, 48 m, 60 m; 20 minutes
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PDD Behavior Inventory
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Immediately post-treatment, 48 m, 60 m; 20 minutes
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ASD symptoms - secondary measure3
Délai: 48 m, 60 m; 10 minutes
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BOSCC
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48 m, 60 m; 10 minutes
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Changement à long terme du fonctionnement cognitif (alternative)
Délai: 48m, 60m; 60 minutes
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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
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48m, 60m; 60 minutes
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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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R01MH115715 (NIH)
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 .
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