- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06486272
The Financial Navigator Program
The Financial Navigator Program - Optimizing Early Child Development by Facilitating Access to Financial Resources in the Neonatal Neurodevelopmental Follow-up Program
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of the current proposal will be to evaluate the feasibility of the Financial Navigator Program in the NNFU.
Research question: What is the feasibility of a Financial Navigator Program in the NNFU?
Setting: The NNFU program follows infants who had a Neonatal Intensive Care admission. Follow-up appointments are scheduled for when the infant is 4, 8, 12, 18 and 36 months of age. We will invite all families at their first appointment in the NNFU to participate in our study.
Study Procedure: Caregivers will be informed about the study at their child's first NNFU visit at 4 months. The clinical team will introduce the study and if interested, they will be approached by a Research Assistant (RA) to provide more details of the study. This can be in person at the clinic visit or in a follow-up phone call depended on families preference. If the caregiver provides consent, an appointment with the Financial Navigator will be arranged.
Intervention: "Access to a Financial Navigator" We anticipate the Financial Navigator will meet at least 2 times and up to 2 additional visits, at a time convenient for the family. Examples of financial services that will likely be offered by the Financial Navigator are tax filing, applying for benefits and financial counseling. The program will be flexible and family centered. Families can choose if they would like to meet the Financial Navigator in person at the NNFU appointment, during another medical appointment, or at another time during a virtual visit. The Financial Navigator will be integrated into the existing SickKids Resource Navigation Service. At the 18-month NNFU visit the study will be completed.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Meta van den Heuvel, MD, PhD
- Phone Number: 422814 +1416-813-7654
- Email: mathilda.vandenheuvel@sickkids.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G1X8
- Hospital for Sick Children
-
Contact:
- Meta van den Heuvel, MD PhD
- Phone Number: 422814 +1416-813-7654
- Email: mathilda.vandenheuvel@sickkids.ca
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Caregivers with a child followed in the NNFU in SickKids will be invited to participate in our study.
- Caregiver needs to attend 4-month NNFU appointment.
Exclusion Criteria:
- There are no exclusion criteria.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Financial Navigator Intervention
|
Intervention: "Access to a Financial Navigator" We anticipate the Financial Navigator will meet at least 2 times and up to 2 additional visits, at a time convenient for the family.
Examples of financial services that will likely be offered by the Financial Navigator are tax filing, applying for benefits and financial counseling.
The program will be flexible and family centered.
Families can choose if they would like to meet the Financial Navigator in person at the NNFU appointment, during another medical appointment, or at another time during a virtual visit.
The Financial Navigator will be integrated into the existing SickKids Resource Navigation Service.
At the 18-month NNFU visit the study will be completed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility; Measured with validated questionnaire including; Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Time Frame: 14 months
|
Validated Questionnaires (Weiner et al, 2017)
|
14 months
|
|
Demand
Time Frame: 14 months
|
Demand will be evaluated by calculating the percentage of families that provided consent and the number of appointments per family with the Financial Navigator.
|
14 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Parenting Stress Index (PSI-Short Form)
Time Frame: 14 months
|
Validated Questionnaire
|
14 months
|
|
Depression, Anxiety, Stress Scales (DASS)
Time Frame: 14 months
|
Validated Questionnaire
|
14 months
|
|
Ages and Stages Questionnaire (ASQ)
Time Frame: 14 months
|
ASQ 4 months and ASQ 18 month version
|
14 months
|
|
Economic outcomes
Time Frame: 14 months
|
Standardized report: include tax filing, receipt of social assistance, Canada Tax Benefit and provincial tax benefit take up, parental leave benefits uptake, and reported uptake of other financial supports
|
14 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1000081699
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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