- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00705328
Families First Edmonton (FFE) (FFE)
Families First Edmonton: The Comparative Effects and Expense of Four Models of Augmenting Services for Low-income Families
This study is designed to provide clear evidence for health and social policymakers about the influence of alternate service-delivery models and practices on enhancing and sustaining low-income family linkages to available services. A challenge faced by Canadian health and social service providers is to promote health for low-income families in a proactive and cost-effective manner. Families with low incomes experience an array of health and social barriers that compromise their resilience, lead to negative family outcomes, and act as barriers to available services. Family barriers are compounded by service delivery barriers and result in reduced opportunities for effective, primary-level services and in increased use of secondary-level services (e.g., emergency room visits, emergency intervention, police involvement), with the obvious increase in costs. Randomized-controlled trials are rare in community-based intervention research.
This Families First Edmonton randomized-controlled trial (RCT) will enable testing of innovative service-delivery models and provide an opportunity for evidence-based decision making for Canadian policy makers. Critical information will be provided about
- optimizing cost effectiveness for public systems
- the long-term effects on the health of low-income family members
- mechanisms that intervene between the interventions and their effect on the health of low-income family members
- building on previous research and on community-based initiatives
- promoting knowledge transfer
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T5A 1C6
- Alberta Human Resources and Employment
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Participant families will
have received low-income assistance either in the form of
- Alberta Works Income Support
- Alberta Child Health Benefits,
- Alberta Works Adult Health Benefits
- participating in City of Edmonton Leisure Access Program
- living in Capital Region Housing
- have a child or children between 0 and 12 years of age
- reside in city of Edmonton
- be able to provide signed consent
Exclusion Criteria:
- Potential study participants will be excluded if they refuse to give informed consent to be interviewed
- are unable to read and write English and an appropriate translator is not available
- have plans to move outside the region
- are unwilling to participate for the entire follow-up period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Primary health care service delivery
|
Experimental: 2
|
Recreation coordination service delivery
|
Experimental: 3
|
a comprehensive service delivery model consisting of PRMHLTH plus REC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increased linkages between low income families and established services in their communities
Time Frame: Baseline, 12-month, 24-month, 36-month follow-up
|
Baseline, 12-month, 24-month, 36-month follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jane Drummond, PhD, University of Alberta
Publications and helpful links
General Publications
- Browne G, Byrne C, Roberts J, Gafni A, Whittaker S. When the bough breaks: provider-initiated comprehensive care is more effective and less expensive for sole-support parents on social assistance. Soc Sci Med. 2001 Dec;53(12):1697-710. doi: 10.1016/s0277-9536(00)00455-x.
- Drummond J, Wiebe N, So S, Schnirner L, Bisanz J, Williamson DL, Mayan M, Templeton L, Fassbender K; Community-University Partnership for the Study of Children, Youth, and Families. Service-integration approaches for families with low income: a Families First Edmonton, community-based, randomized, controlled trial. Trials. 2016 Jul 22;17:343. doi: 10.1186/s13063-016-1444-8.
- Drummond J, Schnirer L, So S, Mayan M, Williamson DL, Bisanz J, Fassbender K, Wiebe N. The protocol for the Families First Edmonton trial (FFE): a randomized community-based trial to compare four service integration approaches for families with low-income. BMC Health Serv Res. 2014 May 19;14:223. doi: 10.1186/1472-6963-14-223.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 137444
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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