Integrating WIC With Early Childhood Systems of Developmental Care

Developmental Disability Clinical Trial

— CDC-WIC  

Official title:

Integrating WIC With Early Childhood Systems of Developmental Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04159038
• Other study ID #: STUDY00019833
• Secondary ID: 19-3773 PO# 2000
• Status: Terminated
• Phase: N/A
• Start date: January 10, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: May 2022
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: September 20, 2021
• Est. primary completion date: September 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 54 Months

Eligibility

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.

Related Conditions & MeSH terms

• Developmental Disabilities
• Developmental Disability
• Food Assistance
• Health Care Disparity

Intervention

Other:
• Intervention Group
The immediate intervention group will receive training on how to identify children at risk for developmental disabilities and how to refer to Early Intervention/Early Childhood Special Education.
• Control group
The control group will continue usual WIC care.

Locations

Country	Name	City	State
United States	Deschutes County WIC	Bend	Oregon
United States	Josephine County WIC	Grants Pass	Oregon
United States	Washington County WIC	Hillsboro	Oregon
United States	Jefferson County WIC	Madras	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	Centers for Disease Control and Prevention, Oregon WIC Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% of Women, Infants, & Children (WIC) participant visits with Early Intervention/Early Childhood Special Education (EI/ECSE) referral.	in immediate versus delayed intervention arms, to understand if the intervention boosted EI/ECSE referral rates.	Start of intervention for 6 months
Primary	% EI/ECSE referrals evaluated by EI/ECSE	by 6 months after referral, in both arms, to see if increased referral actually results in increased EI/ECSE evaluation.	Start of intervention for 6 months
Primary	Time from referral to evaluation	in both arms, to see if the intervention accelerated EI/ECSE evaluation.	Start of intervention for 6 months
Secondary	% of those found eligible on EI/ECSE treatment, 6-months post referral	to see if the intervention increased the number of children receiving treatment services in EI/ECSE.	Start of intervention for 6 months
Secondary	% of public-health identified children referred to EI/ECSE by WIC	to see if WIC can identify and refer children who are high-risk but not otherwise accessing developmental care.	Start of intervention for 6 months

External Links

•   Disability Research and Dissemination Center- Grants Awarded through the DRDC Mechanism