Clinical trial NCT04159038: Integrating WIC With Early Childhood Systems of Developmental Care
Official title: Integrating WIC With Early Childhood Systems of Developmental Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Developmental Disability
Food Assistance
Health Care Disparity
Keywords: Pilot Projects
Randomized Controlled Trial
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Oregon WIC Program
name: Centers for Disease Control and Prevention
First posted: 2019-11-12
Enrollment: 46
Sex: ALL
Maximum age (years): 54
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Parents in the immediate intervention arm sign a study consent that is integrated into the Women, Infants, \& Children (WIC) Referral Form. They also complete a brief demographic survey. No consent is necessary in the delayed intervention arm as only aggregate information will be reported to the study team by Early Intervention/Early Childhood Special Education. EI/ECSE referrals are tracked from clinics in both arms for 6 months in ecWeb. At the end of the data collection period, the study team will meet to refine the intervention based on the experience with the immediate intervention group. Qualitative Interviews will take place with WIC staff, parents who indicate interest, EI/ECSE staff, and primary care providers during and after the post-intervention data collection period.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: % of Women, Infants, & Children (WIC) participant visits with Early Intervention/Early Childhood Special Education (EI/ECSE) referral.
timeFrame: Start of intervention for 6 months
measure: % EI/ECSE referrals evaluated by EI/ECSE
timeFrame: Start of intervention for 6 months
measure: Time from referral to evaluation
timeFrame: Start of intervention for 6 months
Secondary outcomes:
measure: % of those found eligible on EI/ECSE treatment, 6-months post referral
timeFrame: Start of intervention for 6 months
measure: % of public-health identified children referred to EI/ECSE by WIC
timeFrame: Start of intervention for 6 months
Other outcomes:
Locations:
city: Bend
country: United States
facility: Deschutes County WIC
state: Oregon
city: Grants Pass
country: United States
facility: Josephine County WIC
state: Oregon
city: Hillsboro
country: United States
facility: Washington County WIC
state: Oregon
city: Madras
country: United States
facility: Jefferson County WIC
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Katharine Zuckerman, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
References: