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

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ClinicalTrials.gov Identifier: NCT03333629
Recruitment Status : Enrolling by invitation
First Posted : November 7, 2017
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
University of California, Davis
University of Connecticut
Information provided by (Responsible Party):
Diana Robins, Drexel University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Enhanced early detection Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Screening
Official Title: Connecting the Dots: An RCT Integrating Standardized ASD Screening, High-Quality Treatment, and Long-Term Outcomes
Actual Study Start Date : November 29, 2017
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Enhanced early detection
Providers will receive training to administer enhanced early detection strategies.
Behavioral: Enhanced early detection
standardized screening

No Intervention: Usual care
Providers will not change their early detection strategies, but will be monitored.



Primary Outcome Measures :
  1. Change in ASD Symptom Severity [ Time Frame: 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)

  2. Change in Cognitive Functioning [ Time Frame: Change from pre-treatment to immediately post-treatment; 60 minutes ]
    Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL).


Secondary Outcome Measures :
  1. Adaptive Functioning [ Time Frame: Immediately post-treatment, 48 m, 60 m; 45 minutes ]
    Vineland Adaptive Behavior Scales-3

  2. ASD Symptoms - secondary measure1 [ Time Frame: 48 m, 60 m; 45 minutes ]
    Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)

  3. Kindergarten Readiness [ Time Frame: 60 m; 45 minutes ]
    Developmental Indicators for the Assessment of Learning-4

  4. Social Engagement [ Time Frame: 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)

  5. Long-term change in Cognitive Functioning [ Time Frame: 48 m, 60 m; 60 minutes ]
    Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL)

  6. Parent-Child Social Engagement [ Time Frame: 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.

  7. ASD symptoms - secondary measure2 [ Time Frame: Immediately post-treatment, 48 m, 60 m; 20 minutes ]
    PDD Behavior Inventory

  8. ASD symptoms - secondary measure3 [ Time Frame: 48 m, 60 m; 10 minutes ]
    BOSCC

  9. Long-term change in Cognitive Functioning (alternative) [ Time Frame: 48 m, 60 m; 60 minutes ]
    and for children who reach ceiling on the MSEL, we will use the Differential Differential Abilities Scales-II (DAS-II) will be used for children too advanced for Outcome 7



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Months to 50 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03333629


Locations
United States, California
University of California, Davis
Sacramento, California, United States, 95817
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Drexel University
University of California, Davis
University of Connecticut
Investigators
Principal Investigator: Diana Robins, PhD Drexel University

Responsible Party: Diana Robins, Professor, Drexel University
ClinicalTrials.gov Identifier: NCT03333629     History of Changes
Other Study ID Numbers: R01MH115715 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be uploaded to the National Database for Autism Research (NDAR) semi-annually
Time Frame: semi-annual uploads beginning December 2018
Access Criteria: as per NDAR requirements

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Diana Robins, Drexel University:
Autistic Disorder
Early Detection
Early Intervention

Additional relevant MeSH terms:
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders