NCT06486272

Brief 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 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress84%
Sep 2024Sep 2026

First Submitted

Initial submission to the registry

June 19, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

July 3, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

June 19, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

Financial ServicesNeonatal Neurodevelopment Follow-up Clinic

Outcome Measures

Primary Outcomes (2)

  • 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)

    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.

    14 months

Secondary Outcomes (4)

  • Parenting Stress Index (PSI-Short Form)

    14 months

  • Depression, Anxiety, Stress Scales (DASS)

    14 months

  • Ages and Stages Questionnaire (ASQ)

    14 months

  • Economic outcomes

    14 months

Study Arms (1)

Financial Navigator Intervention

EXPERIMENTAL
Other: Financial Navigator

Interventions

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.

Financial Navigator Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Central Study Contacts

Meta van den Heuvel, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Feasibility Pilot Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Pediatrician, Project Investigator, Associate Professor UofT

Study Record Dates

First Submitted

June 19, 2024

First Posted

July 3, 2024

Study Start

September 1, 2024

Primary Completion

January 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 3, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations