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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Enhanced early detection

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
• Enrollment (Actual): 2087
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • University of California, Davis
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Drexel University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ASD Symptom Severity	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	Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL).	Change from pre-treatment to immediately post-treatment; 60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adaptive Functioning	Vineland Adaptive Behavior Scales-3	Immediately post-treatment, 48 m, 60 m; 45 minutes
ASD Symptoms - secondary measure1	Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)	48 m, 60 m; 45 minutes
Kindergarten Readiness	Developmental Indicators for the Assessment of Learning-4	60 m; 45 minutes
Social Engagement	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	Cognitive functioning will be measured by the Mullen Scales of Early Learning (MSEL)	48 m, 60 m; 60 minutes
Parent-Child Social Engagement	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	PDD Behavior Inventory	Immediately post-treatment, 48 m, 60 m; 20 minutes
ASD symptoms - secondary measure3	BOSCC	48 m, 60 m; 10 minutes
Long-term change in Cognitive Functioning (alternative)	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	48 m, 60 m; 60 minutes

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: University of California, Davis; University of Connecticut
• Investigators: Principal Investigator: Diana Robins, PhD, Drexel University

Publications and helpful links

General Publications

• McClure LA, Lee NL, Sand K, Vivanti G, Fein D, Stahmer A, Robins DL. Connecting the Dots: a cluster-randomized clinical trial integrating standardized autism spectrum disorders screening, high-quality treatment, and long-term outcomes. Trials. 2021 May 2;22(1):319. doi: 10.1186/s13063-021-05286-6.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2017
• Primary Completion (Actual): September 6, 2023
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: September 8, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Autistic Disorder; Early Intervention; Early Detection
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: R01MH115715 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be uploaded to the National Database for Autism Research (NDAR) semi-annually
• IPD Sharing Time Frame: semi-annual uploads beginning December 2018
• IPD Sharing Access Criteria: as per NDAR requirements

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No