Developmental DisabilityCDC-WICNCT04159038
Integrating WIC With Early Childhood Systems of Developmental Care
A study testing Intervention Group in people with Developmental Disability and Food Assistance, run by Oregon Health and Science University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 54 months
- Conditions the study is for
- Developmental Disability, Food Assistance, Health Care Disparity
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 4 sitesUnited States
- Study dates
- 10 Jan 2020to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 54 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Deschutes County WIC
Bend, Oregon, 97701
Josephine County WIC
Grants Pass, Oregon, 97526
Washington County WIC
Hillsboro, Oregon, 97124
Jefferson County WIC
Madras, Oregon, 97741
About this study
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.
Read the 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.
- Being tested
- Intervention Group, Control group
- Keywords
- Pilot Projects, Randomized Controlled Trial
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
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 groupOther
The control group will continue usual WIC care.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Intervention Group | Experimental | 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. Receives: Other: Intervention Group |
| Delayed Intervention Group | Other | 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. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
Measured: 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.
Measured: Start of intervention for 6 months
Time from referral to evaluation
in both arms, to see if the intervention accelerated EI/ECSE evaluation.
Measured: Start of intervention for 6 months
Secondary outcomes (2)
% 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.
Measured: Start of intervention for 6 months
% 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.
Measured: Start of intervention for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2019
- Study start10 Jan 2020
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilityStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon WIC Program, Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Katharine Zuckerman, MD MPH, Oregon Health and Science University
- Investigators
- Katharine Zuckerman, M.D., M.P.H., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04159038
- Sponsor's protocol ID
- STUDY00019833
- Other IDs
- 19-3773 PO# 2000043062
- Acronym
- CDC-WIC
- Status last verified
- May 2022
- First submitted
- 7 Nov 2019
- Last updated
- 11 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating WIC With Early Childhood Systems of Developmental Care
- ClinicalTrials.gov ID
- NCT04159038
- Acronym / sponsor ID
- CDC-WIC / STUDY00019833
- Keywords
- Pilot Projects, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Oregon WIC Program, Centers for Disease Control and Prevention
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 12 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Immediate Intervention Group | Experimental | Other: Intervention GroupParents 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 | Other | Other: Control group6 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. |
Who may qualify
- Ages
- Up to 54 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThe 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. | Other | Immediate Intervention Group |
| Control groupThe control group will continue usual WIC care. | Other | Delayed Intervention Group |
Primary outcome
% of Women, Infants, & Children (WIC) participant visits with Early Intervention/Early Childhood Special Education (EI/ECSE) referral.
Time frame: Start of intervention for 6 months
in immediate versus delayed intervention arms, to understand if the intervention boosted EI/ECSE referral rates.
% EI/ECSE referrals evaluated by EI/ECSE
Time frame: 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.
Time from referral to evaluation
Time frame: Start of intervention for 6 months
in both arms, to see if the intervention accelerated EI/ECSE evaluation.
2 secondary outcomes
% of those found eligible on EI/ECSE treatment, 6-months post referral
Time frame: Start of intervention for 6 months
% of public-health identified children referred to EI/ECSE by WIC
Time frame: Start of intervention for 6 months
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2022.
- Disability Research and Dissemination Center- Grants Awarded through the DRDC MechanismLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katharine Zuckerman, M.D., M.P.H. principal investigator
Oregon Health and Science University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Developmental Disability and Food Assistance, run by Oregon Health and Science University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of Women, Infants, & Children (WIC) participant visits with Early Intervention/Early Childhood Special Education (EI/ECSE) referral. (time frame: Start of intervention for 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2022.