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An SRT Model for Early Access to ASD Intervention

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screen-Refer-Treat Intervention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Screening, Preventive intervention, Risk

Eligibility Criteria

16 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Screen-Refer-Treat Intervention

Control

Arm Description

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

No intervention received.

Outcomes

Primary Outcome Measures

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
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
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
Change in average age at which children receive an ASD diagnosis from baseline (pre-SRT intervention) to post-SRT intervention
Caregiver report
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
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

Secondary Outcome Measures

Full Information

First Posted
March 26, 2015
Last Updated
November 1, 2022
Sponsor
University of Washington
Collaborators
Seattle Children's Hospital, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT02409303
Brief Title
An SRT Model for Early Access to ASD Intervention
Official Title
A Screen-Refer-Treat (SRT) Model to Promote Earlier Access to ASD Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Seattle Children's Hospital, National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, Screening, Preventive intervention, Risk

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
627 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screen-Refer-Treat Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention received.
Intervention Type
Behavioral
Intervention Name(s)
Screen-Refer-Treat Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in rates of ASD screening by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention
Description
PCP self-report
Time Frame
5 times over 4 years
Title
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
Description
PCP self-report
Time Frame
5 times over 4 years
Title
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
Description
Caregiver report
Time Frame
Every 3 months until toddlers turn 36 months of age
Title
Change in average age at which children receive an ASD diagnosis from baseline (pre-SRT intervention) to post-SRT intervention
Description
Caregiver report
Time Frame
Every 3 months until toddlers turn 36 months of age
Title
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
Description
Caregiver self-report
Time Frame
Every 3 months until children turn 36 months of age
Title
Change in levels of pivotal social-communicative behaviors in toddlers at risk for ASD from baseline (pre-SRT intervention) to post-SRT intervention
Description
Caregiver report
Time Frame
Every 3 months until children turn 36 months of age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy L Stone, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33901728
Citation
Steinman KJ, Stone WL, Ibanez LV, Attar SM. Reducing Barriers to Autism Screening in Community Primary Care: A Pragmatic Trial Using Web-Based Screening. Acad Pediatr. 2022 Mar;22(2):263-270. doi: 10.1016/j.acap.2021.04.017. Epub 2021 Apr 23.
Results Reference
derived
PubMed Identifier
31174514
Citation
Ibanez LV, Stoep AV, Myers K, Zhou C, Dorsey S, Steinman KJ, Stone WL. Promoting early autism detection and intervention in underserved communities: study protocol for a pragmatic trial using a stepped-wedge design. BMC Psychiatry. 2019 Jun 7;19(1):169. doi: 10.1186/s12888-019-2150-3.
Results Reference
derived

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An SRT Model for Early Access to ASD Intervention

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