An interventional study of Screen-Refer-Treat Intervention in Autism Spectrum Disorder, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 16 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by University of Washington · Not applicable, Interventional, and Health services research
This project will implement and evaluate an innovative healthcare service delivery model designed to promote earlier access to specialized intervention for toddlers with ASD. The Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early identification and intervention by involving both medical and EI providers, and represents a practical and sustainable strategy for bridging the gap between ASD concerns and ASD intervention.
Although caregivers often become concerned about their child by 17-19 months of age, children do not typically receive a diagnosis of autism spectrum disorder (ASD) until they are 4½ years old, or older for Hispanic families. It is now well documented that early participation in ASD-specialized intervention can lead to significant improvements in skills and behavior for toddlers with ASD. However, despite the availability of publicly funded Part C early intervention (EI) services, long waits for a formal ASD diagnosis can prevent toddlers from receiving appropriately specialized intervention during the critical birth-to-three years. In addition, caregivers concerned about ASD experience high levels of uncertainty and stress during this waiting period. This project will implement and evaluate an innovative healthcare service delivery model designed to promote earlier access to specialized intervention for toddlers with ASD. The Screen-Refer-Treat (SRT) model provides a coordinated and cost-effective approach to early identification and intervention by involving both medical and EI providers, and represents a practical and sustainable strategy for bridging the gap between ASD concerns and ASD intervention. The SRT model, which builds on the availability of validated ASD screening tools and low-cost behaviorally-based ASD interventions, will be implemented in four diverse communities across Washington State to evaluate changes in service delivery practices for toddlers with Hispanic as well as Non-Hispanic backgrounds. The SRT model comprises three components: (1) universal ASD screening at 16-20 months and prompt referral to EI programs by primary care physicians (PCPs); (2) expedited ASD assessments within EI programs; and (3) use of an inexpensive, evidence-based ASD-specialized intervention by EI providers. An electronic version of the Modified Checklist for Autism (M-CHAT) with automated scoring that incorporates relevant follow-up questions will be provided to PCP practices, and distance coaching via telemedicine will be available to EI providers to support their ASD assessment and intervention activities. A stepped wedge cluster RCT design will be used to evaluate implementation and outcomes of the SRT model. Data on screening, referral, assessment, and intervention practices will be collected from 40 PCPs and 80 EI providers across the state prior to and following SRT implementation to identify practice changes. In addition, separate samples of caregivers of toddlers with ASD concerns (n=245) will be recruited from communities before and after SRT implementation and followed prospectively to measure differences and changes over time in caregiver wellbeing, parenting efficacy, satisfaction with healthcare systems, and toddler's social-communicative behaviors. We predict that implementation of the SRT model will be associated with higher rates of ASD screening by PCPs, earlier referral to EI programs, earlier initiation of ASD-specialized intervention, reduced time between ASD concerns and diagnosis, and improved caregiver and child outcomes.
1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.
This study's enrollment of 627 is above the median of 52 across 1,391 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →University of Washington is the lead sponsor of 1,431 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
PCPs:
-PCPs must work at a participating primary care practice.
EI Providers:
-EI providers must work at a participating early intervention agency.
Caregivers and Toddlers:
To be categorized as part of the ASD Concerns Sample recruited from PCP offices:
To be categorized as part of the No ASD Concerns Sample recruited from PCP offices:
- Toddlers must be between 16-20 months of age
To be categorized as part of the ASD Dx/ASD Concerns Sample recruited from EI agencies:
Exclusion Criteria:
-There are no exclusion criteria for PCPs or EI providers.
Caregivers/toddlers meeting the inclusion criteria described above will be excluded if the caregiver:
-reports that the toddler has any severe visual, auditory, or physical impairments, and/or serious medical, genetic, or neurological disorders
PCPs and EI Providers receive training workshops on validated, evidence-based practices (i.e., Online M-CHAT-R/F, STAT, and RIT) and then receive TA (i.e., Screen-Refer-Treat Intervention). At the county level, providers are randomized to the order/timing at which they will receive this system intervention
Behavioral: Screen-Refer-Treat Intervention
No intervention received.
This intervention is healthcare system intervention that trains providers on validated screening tools (Online M-CHAT-R/F and STAT) and an evidence-based behavioral intervention (RIT). PCPs receive a 2-hour training workshop on the Online M-CHAT-R/F and EI Providers receive 2 day-long training workshops, one on the STAT/expedited assessment and one RIT.
Change in rates of ASD screening by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention
PCP self-report
Time frame: 5 times over 4 years
Change in rates of referral for early intervention services by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention
PCP self-report
Time frame: 5 times over 4 years
Change in percent of toddlers at risk for ASD recieving ASD-specialized behavioral intervention before 24 months from baseline (pre-SRT intervention) to post-SRT intervention
Caregiver report
Time frame: Every 3 months until toddlers turn 36 months of age
Change in average age at which children receive an ASD diagnosis from baseline (pre-SRT intervention) to post-SRT intervention
Caregiver report
Time frame: Every 3 months until toddlers turn 36 months of age
Change in levels of parenting stress, parenting efficacy, health quality of life, and satisfaction with the healthcare system from baseline (pre-SRT intervention) to post-SRT intervention
Caregiver self-report
Time frame: Every 3 months until children turn 36 months of age
Change in levels of pivotal social-communicative behaviors in toddlers at risk for ASD from baseline (pre-SRT intervention) to post-SRT intervention
Caregiver report
Time frame: Every 3 months until children turn 36 months of age
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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