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

13. Februar 2023 aktualisiert von: 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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

2087

Phase

  • Phase 4

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • California
      • Sacramento, California, Vereinigte Staaten, 95817
        • University of California, Davis
    • Connecticut
      • Storrs, Connecticut, Vereinigte Staaten, 06269
        • University of Connecticut
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19104
        • Drexel University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

1 Jahr bis 4 Jahre (KIND)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: SCREENING
  • Zuteilung: ZUFÄLLIG
  • Interventionsmodell: PARALLEL
  • Maskierung: DOPPELT

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
EXPERIMENTAL: Enhanced early detection
Providers will receive training to administer enhanced early detection strategies.
standardized screening
KEIN_EINGRIFF: Usual care
Providers will not change their early detection strategies, but will be monitored.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in ASD Symptom Severity
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Adaptive Functioning
Zeitfenster: Immediately post-treatment, 48 m, 60 m; 45 minutes
Vineland Adaptive Behavior Scales-3
Immediately post-treatment, 48 m, 60 m; 45 minutes
ASD Symptoms - secondary measure1
Zeitfenster: 48m, 60m; 45 Minuten
Autismus-Diagnose-Beobachtungsplan, zweite Ausgabe (ADOS-2)
48m, 60m; 45 Minuten
Kindergarten Readiness
Zeitfenster: 60 m; 45 minutes
Developmental Indicators for the Assessment of Learning-4
60 m; 45 minutes
Social Engagement
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 48 m, 60 m; 10 minutes
BOSCC
48 m, 60 m; 10 minutes
Long-term change in Cognitive Functioning (alternative)
Zeitfenster: 48m, 60m; 60 Minuten
und für Kinder, die die MSEL-Obergrenze erreichen, verwenden wir die Differential Differentielle Abilities Scales-II (DAS-II) für Kinder, die für Ergebnis 7 zu weit fortgeschritten sind
48m, 60m; 60 Minuten

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Diana Robins, PhD, Drexel University

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (TATSÄCHLICH)

29. November 2017

Primärer Abschluss (ERWARTET)

30. Juni 2023

Studienabschluss (ERWARTET)

30. Juni 2023

Studienanmeldedaten

Zuerst eingereicht

8. September 2017

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. November 2017

Zuerst gepostet (TATSÄCHLICH)

7. November 2017

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (SCHÄTZEN)

14. Februar 2023

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

13. Februar 2023

Zuletzt verifiziert

1. Februar 2023

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

semi-annual uploads beginning December 2018

IPD-Sharing-Zugriffskriterien

as per NDAR requirements

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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