跳至主要内容
临床试验/NCT02374541
NCT02374541已完成不适用

Screening and Linkage to Services for Autism

University of Colorado, Denver6 个研究点 分布在 1 个国家目标入组 305 人开始时间: 2015年2月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
305
试验地点
6
主要终点
Completion of developmental evaluation / eligibility determination

研究概览

简要总结

The SaLSA (Screening and Linkage to Services for Autism) study will test whether patient navigation can help disadvantaged families obtain earlier diagnosis and treatment for their children who have had a positive screening test for autism spectrum disorder. Half of the families will be offered help from an autism patient navigator. The other half will receive standard care.

详细描述

Despite its relatively high rate of occurrence, autism spectrum disorder (ASD) is under-diagnosed and under-treated in young children, particularly in minority and disadvantaged populations. Although screening for ASD in the primary care setting is recommended as best practice, inadequate attention has been paid to addressing important obstacles to early recognition of ASD, including barriers to referral after positive screening, completion of diagnostic evaluations, and receipt of treatment. Patient navigation was originally developed to reduce health care disparities. The patient navigator guides patients with suspicious findings (e.g., a positive screening test) through and around barriers to care to ensure timely diagnosis and treatment. Patient navigation has improved receipt of preventive care among low-income, minority children but has not been tested for improving early identification and treatment of autism spectrum disorders. The goal of this study is to test the effectiveness and feasibility of patient navigation to facilitate autism screening follow-up, diagnostic evaluation, and linkage to early intervention in a very young, disadvantaged, minority population. To increase patient navigation's potential for widespread application and public health impact, this study uses the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework, a set of criteria for translating research into action, to guide planning and evaluation. The intervention's Reach, Effectiveness, Adoption, Implementation and Maintenance over time will be examined.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Months 至 32 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Receives medical care at Denver Community Health Services (DCHS) clinic
  • Positive M-CHAT screening test (score 3 or higher) between ages 16 and 30 months at DCHS
  • Resident of City and County of Denver

排除标准

  • Existing diagnosis of autism spectrum disorder
  • Sibling of enrolled subject

结局指标

主要结局

Completion of developmental evaluation / eligibility determination

时间窗: 36 months of age

Indicated developmental evaluation (aka eligibility determination) completed (Yes/No)

次要结局

  • Time to referral for and implementation of developmental evaluation / eligibility determination(36 months of age)
  • Time to initiation of indicated early intervention services(36 months of age)
  • Referral for developmental evaluation / eligibility determination(36 months of age)
  • Age at referral for and implementation of developmental evaluation / eligibility determination(36 months of age)
  • Individualized Family Service Plan (IFSP) development(36 months of age)
  • Age at Individualized Family Service Plan (IFSP) development(36 months of age)
  • Initiation of indicated early intervention (EI) services(36 months of age)
  • Age at initiation of indicated early intervention services(36 months of age)
  • Time to Individualized Family Service Plan (IFSP) development(36 months of age)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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