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临床试验/NCT04159038
NCT04159038终止不适用

Integrating WIC With Early Childhood Systems of Developmental Care

Oregon Health and Science University8 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2020年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
46
试验地点
8
主要终点
% of Women, Infants, & Children (WIC) participant visits with Early Intervention/Early Childhood Special Education (EI/ECSE) referral.

研究概览

简要总结

This study's goals are to improve connections between Oregon Women, Infants, & Children (WIC) clinics, primary care providers, and Early Intervention/Early Childhood Special Education programs (EI/ECSE), in order to help children with suspected developmental delays get the services they need.

详细描述

Disparities exist in early identification of developmental disabilities, particularly for families from low-income and/or racial ethnic minority backgrounds. As WIC has frequent contact with children and families in the first five years of life, it is optimally positioned to play a unique role in early identification of developmental disabilities. However, WIC staff are not formally trained in child development outside of program's primary focus on nutrition and supporting the feeding relationship nor is formal screening for potential developmental delays an allowable WIC expense. In our prior research Oregon WIC staff reported being frequently asked by parents about potential concerns yet they also reported not being well connected to pediatric primary care, Part C Early Intervention (EI), or other resources who could further assess these concerns. In this study the investigators propose to design and pilot test a 2-part intervention to enhance the link between WIC and early childhood resources. The 2-part intervention includes: (1) WIC staff training delivered at the Local Agency which will: build staff confidence in discussing developmental concerns with families, familiarize staff with the CDC Learn the Signs Act Early (LTSAE) material which may be used to support those conversations, provide easy tips for encouraging early language and literacy development with parents, and study procedures (2) the creation of a standardized, direct, closed-loop referral process from WIC to EI for families with an identified concern who agree to the referral. EI will notify the child's primary care provider of the referral as per usual EI protocol. A referral form has been approved by the Oregon Department of Education (ODE) to support the direct referral from WIC to EI, meeting all ODE FERPA requirements. In addition, a data use agreement has been approved by ODE to allow the study team to access data on referred children to determine if they completed further assessment and the given diagnosis (if any). While our primary quantitative outcomes of interest are the number of children with a potential developmental concern who are referred directly from WIC to EI, the timing of follow-up assessment by EI from that referral, services plan & start of services; the project really centers on improving processes between organizations who are key stakeholders in referral, assessment, and treatment. Therefore, secondary outcomes include feasibility and acceptability of the intervention amongst WIC staff, EI staff and primary care providers Upon completion of the study the investigators hope to apply our findings to scale up the WIC staff training and closed-loop referral process to take it Statewide. If successful the investigators will disseminate findings through the National WIC Association to encourage other State and Tribal WIC Authorities to adopt our procedures as best practices.

研究设计

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

入排标准

年龄范围
— 至 54 Months(Child)
性别
All
接受健康志愿者

入选标准

  • The primary subject population of interest are Women, Infants, & Children families who in the course of a WIC visit identify a potential developmental concern and agree to a direct referral from WIC to Early Intervention to further assess that concern. To be eligible for the study, the parent/guardian must speak English or Spanish. The child with the identified concern must be under 54 months of age as the investigators will need to follow the child for 6 months to determine initial outcomes and children are no longer eligible for WIC after their 5th birthday.
  • WIC staff at the 4 intervention agencies, EI staff in the 4 communities in which the 4 intervention WIC Local Agencies are located, and primary care providers (PCPs) who have had a patient referred to EI directly from WIC will all be invited to participate in a telephone interview to give their perspective on the process. The only staff inclusion requirement is that these staff are currently working in their professional role in the county studied.

排除标准

  • Family speaks language that isn't English or Spanish. Child is older than 54 months.
  • Staff does not work in their professional role in the county studied.

结局指标

主要结局

% of Women, Infants, & Children (WIC) participant visits with Early Intervention/Early Childhood Special Education (EI/ECSE) referral.

时间窗: Start of intervention for 6 months

in immediate versus delayed intervention arms, to understand if the intervention boosted EI/ECSE referral rates.

Time from referral to evaluation

时间窗: Start of intervention for 6 months

in both arms, to see if the intervention accelerated EI/ECSE evaluation.

% EI/ECSE referrals evaluated by EI/ECSE

时间窗: Start of intervention for 6 months

by 6 months after referral, in both arms, to see if increased referral actually results in increased EI/ECSE evaluation.

次要结局

  • % of public-health identified children referred to EI/ECSE by WIC(Start of intervention for 6 months)
  • % of those found eligible on EI/ECSE treatment, 6-months post referral(Start of intervention for 6 months)

研究者

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

Katharine Zuckerman, MD MPH

Principal Investigator

Oregon Health and Science University

研究点 (8)

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