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Integrating WIC With Early Childhood Systems of Developmental Care (CDC-WIC)

Primary Purpose

Developmental Disability, Food Assistance, Health Care Disparity

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Group
Control group
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Developmental Disability focused on measuring Pilot Projects, Randomized Controlled Trial

Eligibility Criteria

undefined - 54 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Deschutes County WIC
  • Josephine County WIC
  • Washington County WIC
  • Jefferson County WIC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Immediate Intervention Group

Delayed Intervention Group

Arm Description

Parents in the immediate intervention arm sign a study consent that is integrated into the 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 EI/ECSE. 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.

6 months after the immediate intervention group receives their training, the delayed intervention group will receive the training. Prior to implementation of the training in the delayed intervention group, the study team will meet with the Stakeholder Advisory Board. It will review interim results and consider the efficacy of the intervention as a whole. Based on actual use patterns and stakeholder feedback, the investigators will make improvements to the intervention prior to implementing it in the delayed intervention group.

Outcomes

Primary Outcome Measures

% 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.
% 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.
Time from referral to evaluation
in both arms, to see if the intervention accelerated EI/ECSE evaluation.

Secondary Outcome Measures

% 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.
% 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.

Full Information

First Posted
November 7, 2019
Last Updated
May 5, 2022
Sponsor
Oregon Health and Science University
Collaborators
Oregon WIC Program, Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04159038
Brief Title
Integrating WIC With Early Childhood Systems of Developmental Care
Acronym
CDC-WIC
Official Title
Integrating WIC With Early Childhood Systems of Developmental Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Study sites were closed in March 2020, due to COVID-19 and did not re-open; follow-up data were collected for 6 months subsequently of already enrolled subjects
Study Start Date
January 10, 2020 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Oregon WIC Program, Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Developmental Disability, Food Assistance, Health Care Disparity
Keywords
Pilot Projects, Randomized Controlled Trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate Intervention Group
Arm Type
Experimental
Arm Description
Parents in the immediate intervention arm sign a study consent that is integrated into the 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 EI/ECSE. 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.
Arm Title
Delayed Intervention Group
Arm Type
Other
Arm Description
6 months after the immediate intervention group receives their training, the delayed intervention group will receive the training. Prior to implementation of the training in the delayed intervention group, the study team will meet with the Stakeholder Advisory Board. It will review interim results and consider the efficacy of the intervention as a whole. Based on actual use patterns and stakeholder feedback, the investigators will make improvements to the intervention prior to implementing it in the delayed intervention group.
Intervention Type
Other
Intervention Name(s)
Intervention Group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
The control group will continue usual WIC care.
Primary Outcome Measure Information:
Title
% of Women, Infants, & Children (WIC) participant visits with Early Intervention/Early Childhood Special Education (EI/ECSE) referral.
Description
in immediate versus delayed intervention arms, to understand if the intervention boosted EI/ECSE referral rates.
Time Frame
Start of intervention for 6 months
Title
% EI/ECSE referrals evaluated by EI/ECSE
Description
by 6 months after referral, in both arms, to see if increased referral actually results in increased EI/ECSE evaluation.
Time Frame
Start of intervention for 6 months
Title
Time from referral to evaluation
Description
in both arms, to see if the intervention accelerated EI/ECSE evaluation.
Time Frame
Start of intervention for 6 months
Secondary Outcome Measure Information:
Title
% of those found eligible on EI/ECSE treatment, 6-months post referral
Description
to see if the intervention increased the number of children receiving treatment services in EI/ECSE.
Time Frame
Start of intervention for 6 months
Title
% of public-health identified children referred to EI/ECSE by WIC
Description
to see if WIC can identify and refer children who are high-risk but not otherwise accessing developmental care.
Time Frame
Start of intervention for 6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
54 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katharine Zuckerman, M.D., M.P.H.
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deschutes County WIC
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Josephine County WIC
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97526
Country
United States
Facility Name
Washington County WIC
City
Hillsboro
State/Province
Oregon
ZIP/Postal Code
97124
Country
United States
Facility Name
Jefferson County WIC
City
Madras
State/Province
Oregon
ZIP/Postal Code
97741
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.disabilityresearchcenter.com/research/awarded-grants/
Description
Disability Research and Dissemination Center- Grants Awarded through the DRDC Mechanism

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Integrating WIC With Early Childhood Systems of Developmental Care

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