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An SRT Model for Early Access to ASD Intervention

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ClinicalTrials.gov Identifier: NCT02409303
Recruitment Status : Recruiting
First Posted : April 6, 2015
Last Update Posted : October 30, 2017
Sponsor:
Collaborators:
Seattle Children's Hospital
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Wendy Stone, University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: Screen-Refer-Treat Intervention Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 555 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Screen-Refer-Treat (SRT) Model to Promote Earlier Access to ASD Intervention
Study Start Date : July 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Screen-Refer-Treat Intervention
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
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.

No Intervention: Control
No intervention received.



Primary Outcome Measures :
  1. Change in rates of ASD screening by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention [ Time Frame: 5 times over 4 years ]
    PCP self-report

  2. 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 [ Time Frame: 5 times over 4 years ]
    PCP self-report

  3. 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 [ Time Frame: Every 3 months until toddlers turn 36 months of age ]
    Caregiver report

  4. Change in average age at which children receive an ASD diagnosis from baseline (pre-SRT intervention) to post-SRT intervention [ Time Frame: Every 3 months until toddlers turn 36 months of age ]
    Caregiver report

  5. 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 [ Time Frame: Every 3 months until children turn 36 months of age ]
    Caregiver self-report

  6. Change in levels of pivotal social-communicative behaviors in toddlers at risk for ASD from baseline (pre-SRT intervention) to post-SRT intervention [ Time Frame: Every 3 months until children turn 36 months of age ]
    Caregiver report



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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:

  • Toddlers must demonstrate ASD risk/concern by meeting at least one of the following criteria: (1) behaviorally-based caregiver concerns about the presence of ASD; (2) behaviorally-based PCP concerns about the presence of ASD; (3) having an older sibling with an ASD diagnosis; or (4) screening positive for ASD on a validated screening tool.
  • Toddlers must be between 16-20 months of age

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:

  • Toddlers must demonstrate ASD risk/concern by meeting at least one of the following criteria: (1) behaviorally-based caregiver concerns about the presence of ASD; (2) behaviorally-based PCP concerns about the presence of ASD; (3) having an older sibling with an ASD diagnosis; (4) screening positive for ASD on a validated screening tool; or (5) parent-report of an ASD diagnosis.
  • Toddlers must be between 16-30 months of age

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


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): NCT02409303


Contacts
Contact: Lisa V. Ibanez, PhD 206-616-7358 libanez1@uw.edu
Contact: Wendy L Stone, PhD 206-685-2821 stonew@uw.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Lisa V Ibanez, PhD    206-616-7358    libanez1@uw.edu   
Contact: Wendy L Stone, PhD    206-685-2821    stonew@uw.edu   
Sponsors and Collaborators
University of Washington
Seattle Children's Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Wendy L Stone, PhD University of Washington

Responsible Party: Wendy Stone, Professor of Psychology, University of Washington
ClinicalTrials.gov Identifier: NCT02409303     History of Changes
Other Study ID Numbers: 47892
R01MH104302-01 ( U.S. NIH Grant/Contract )
First Posted: April 6, 2015    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by Wendy Stone, University of Washington:
Autism Spectrum Disorder
Screening
Preventive intervention
Risk

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