跳至主要内容
临床试验/NCT02409303
NCT02409303已完成不适用

A Screen-Refer-Treat (SRT) Model to Promote Earlier Access to ASD Intervention

University of Washington2 个研究点 分布在 1 个国家目标入组 627 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
627
试验地点
2
主要终点
Change in average age at which children receive an ASD diagnosis from baseline (pre-SRT intervention) to post-SRT intervention

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
16 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: Every 3 months until toddlers turn 36 months of age

Caregiver report

Change in rates of ASD screening by PCPs at the 18-month Well-Child visit from baseline (pre-SRT intervention) to post-SRT intervention

时间窗: 5 times over 4 years

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

时间窗: Every 3 months until toddlers turn 36 months of age

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

时间窗: Every 3 months until children turn 36 months of age

Caregiver 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

时间窗: 5 times over 4 years

PCP 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

时间窗: Every 3 months until children turn 36 months of age

Caregiver report

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wendy Stone

Professor of Psychology

University of Washington

研究点 (2)

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