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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
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Sacramento, California, United States, 95817
- University of California, Davis
-
-
Connecticut
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Storrs, Connecticut, United States, 06269
- University of Connecticut
-
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Drexel University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Enhanced early detection
Providers will receive training to administer enhanced early detection strategies.
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standardized screening
|
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No Intervention: Usual care
Providers will not change their early detection strategies, but will be monitored.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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Change from pre-treatment to immediately post-treatment; 10 minutes
|
|
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).
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Change from pre-treatment to immediately post-treatment; 60 minutes
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adaptive Functioning
Time Frame: 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
Time Frame: 48 m, 60 m; 45 minutes
|
Autism Diagnostic Observation Schedule, Second Edition (ADOS-2)
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48 m, 60 m; 45 minutes
|
|
Kindergarten Readiness
Time Frame: 60 m; 45 minutes
|
Developmental Indicators for the Assessment of Learning-4
|
60 m; 45 minutes
|
|
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)
|
Immediately post-treatment, 48 m, 60 m; 15 minutes
|
|
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)
|
48 m, 60 m; 60 minutes
|
|
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.
|
Immediately post-treatment, 48 m, 60 m; 15 minutes
|
|
ASD symptoms - secondary measure2
Time Frame: 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
Time Frame: 48 m, 60 m; 10 minutes
|
BOSCC
|
48 m, 60 m; 10 minutes
|
|
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
|
48 m, 60 m; 60 minutes
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Diana Robins, PhD, Drexel University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- R01MH115715 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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