Study 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
Integrating WIC With Early Childhood Systems of Developmental Care
CDC-WIC
2 other identifiers
interventional
46
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2019
CompletedFirst Posted
Study publicly available on registry
November 12, 2019
CompletedStudy Start
First participant enrolled
January 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2021
CompletedMay 11, 2022
May 1, 2022
1.7 years
November 7, 2019
May 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
% 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
% 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
Time from referral to evaluation
in both arms, to see if the intervention accelerated EI/ECSE evaluation.
Start of intervention for 6 months
Secondary Outcomes (2)
% of those found eligible on EI/ECSE treatment, 6-months post referral
Start of intervention for 6 months
% of public-health identified children referred to EI/ECSE by WIC
Start of intervention for 6 months
Study Arms (2)
Immediate Intervention Group
EXPERIMENTALParents 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.
Delayed Intervention Group
OTHER6 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- Oregon WIC Programcollaborator
- Centers for Disease Control and Preventioncollaborator
Study Sites (4)
Deschutes County WIC
Bend, Oregon, 97701, United States
Josephine County WIC
Grants Pass, Oregon, 97526, United States
Washington County WIC
Hillsboro, Oregon, 97124, United States
Jefferson County WIC
Madras, Oregon, 97741, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katharine Zuckerman, M.D., M.P.H.
Oregon Health and Science University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 7, 2019
First Posted
November 12, 2019
Study Start
January 10, 2020
Primary Completion
September 20, 2021
Study Completion
September 20, 2021
Last Updated
May 11, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share