Financial HardshipNCT06486272
The Financial Navigator Program
A study testing Financial Navigator in people with Financial Hardship, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Over one third of caregivers with a child admitted to the Hospital for Sick Children (SickKids) reported having difficulty making ends meet. The SickKids Medical-Financial Partnership (MFP) working group conducted in-depth interviews exploring financial needs and supports with selected caregivers in the Neonatal… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Financial Hardship
- What is being tested?
- Financial Navigator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2024to Sep 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Hospital for Sick Children
Toronto, Ontario, M5G1X8
Meta van den Heuvel, MD PhD, +1416-813-7654 ext. 422814, mathilda.vandenheuvel@sickkids.ca
About this study
Official title: The Financial Navigator Program - Optimizing Early Child Development by Facilitating Access to Financial Resources in the Neonatal Neurodevelopmental Follow-up Program
Over one third of caregivers with a child admitted to the Hospital for Sick Children (SickKids) reported having difficulty making ends meet. The SickKids Medical-Financial Partnership (MFP) working group conducted in-depth interviews exploring financial needs and supports with selected caregivers in the Neonatal Neurodevelopmental Follow-up Program (NNFU). Results identified financial stress (including difficulties with employment, high cost of living, poverty, food insecurity, inaccessible supports, benefit time lines, costs of therapy) as a major theme. Caregivers generally supported the idea of hospital-based financial services. In this feasibility study we will trial a Financial Navigator Program in the NNFU.
Read the 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.
- Conditions
- Financial Hardship
- Being tested
- Financial Navigator
- Keywords
- Financial Services, Neonatal Neurodevelopment Follow-up Clinic
- Medical subject headings
- Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial NavigatorOther
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 group | Role | What they receive |
|---|---|---|
| Financial Navigator Intervention | Experimental | Not described Receives: Other: Financial Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility; Measured with validated questionnaire including; Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM).
Validated Questionnaires (Weiner et al, 2017)
Measured: 14 months
Demand
Demand will be evaluated by calculating the percentage of families that provided consent and the number of appointments per family with the Financial Navigator.
Measured: 14 months
Secondary outcomes (4)
Parenting Stress Index (PSI-Short Form)
Validated Questionnaire
Measured: 14 months
Depression, Anxiety, Stress Scales (DASS)
Validated Questionnaire
Measured: 14 months
Ages and Stages Questionnaire (ASQ)
ASQ 4 months and ASQ 18 month version
Measured: 14 months
Economic outcomes
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
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study startSep 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial HardshipStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility Pilot Study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Edwin S.H. Leong Centre for Healthy Children
- Responsible party
- Principal investigator, Mathilda Vandenheuvel, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486272
- Sponsor's protocol ID
- 1000081699
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Financial Navigator Program - Optimizing Early Child Development by Facilitating Access to Financial Resources in the Neonatal Neurodevelopmental Follow-up Program
- ClinicalTrials.gov ID
- NCT06486272
- Acronym / sponsor ID
- 1000081699
- Conditions
- Financial Hardship
- Keywords
- Financial Services, Neonatal Neurodevelopment Follow-up Clinic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Edwin S.H. Leong Centre for Healthy Children
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Jul 2024 (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.
Over one third of caregivers with a child admitted to the Hospital for Sick Children (SickKids) reported having difficulty making ends meet. The SickKids Medical-Financial Partnership (MFP) working group conducted in-depth interviews exploring financial needs and supports with selected caregivers in the Neonatal Neurodevelopmental Follow-up Program (NNFU). Results identified financial stress (including difficulties with employment, high cost of living, poverty, food insecurity, inaccessible supports, benefit time lines, costs of therapy) as a major theme. Caregivers generally supported the idea of hospital-based financial services. In this feasibility study we will trial a Financial Navigator Program in the NNFU.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility Pilot Study
| Arm | Type | Receives |
|---|---|---|
| Financial Navigator Intervention | Experimental | Other: Financial Navigator |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
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 |
|---|---|---|
| Financial NavigatorIntervention: "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. | Other | Financial Navigator Intervention |
Primary outcome
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)
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.
4 secondary outcomes
Parenting Stress Index (PSI-Short Form)
Time frame: 14 months
Depression, Anxiety, Stress Scales (DASS)
Time frame: 14 months
Ages and Stages Questionnaire (ASQ)
Time frame: 14 months
Economic outcomes
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Navigator in people with Financial Hardship, run by The Hospital for Sick Children at 1 site in Canada.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meta van den Heuvel, MD, PhD (+1416-813-7654 ext. 422814, mathilda.vandenheuvel@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 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 3 Jul 2024.