ClinicalTrials.gg
CompletedNCT00705328FFEUpdated Apr 21, 2016

Families First Edmonton (FFE)

A Phase 2 interventional study of Primary Health Care Model (PRMHLTH) and Recreation Coordination Model (REC) in Low-Income Population, sponsored by University of Alberta. Completed at 1 site in Canada. Per ClinicalTrials.gov, last updated 2016-04-21.

Sponsored by University of Alberta · Phase 2, Interventional, and Health services research

Phase
Phase 2
Study type
Interventional
Enrollment
2,400
Allocation
Randomized
Sex
All
01

Study summary

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

  1. optimizing cost effectiveness for public systems
  2. the long-term effects on the health of low-income family members
  3. mechanisms that intervene between the interventions and their effect on the health of low-income family members
  4. building on previous research and on community-based initiatives
  5. promoting knowledge transfer
02

Conditions studied

  • Low-Income Population

Keywords

  • low-income families
  • children
  • recreation
  • family healthy lifestyle
  • linkages to community resources
  • Families with low incomes
  • working poor
  • welfare recipients
03

In context

Lead sponsor

University of Alberta is the lead sponsor of 819 studies on the registry; 166 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participant families will

    1. have received low-income assistance either in the form of

      1. Alberta Works Income Support
      2. Alberta Child Health Benefits,
      3. Alberta Works Adult Health Benefits
      4. participating in City of Edmonton Leisure Access Program
      5. living in Capital Region Housing
    2. have a child or children between 0 and 12 years of age
    3. reside in city of Edmonton
    4. be able to provide signed consent

Exclusion criteria

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
05

Study design

Phase
Phase 2
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Investigator)
Enrollment
2,400 participants (actual)

Study arms

  • Experimental
    1

    Behavioral: Primary Health Care Model (PRMHLTH)

  • Experimental
    2

    Behavioral: Recreation Coordination Model (REC)

  • Experimental
    3

    Behavioral: Comprehensive Model (COMP)

Interventions

  • BehavioralPrimary Health Care Model (PRMHLTH)

    Primary health care service delivery

  • BehavioralRecreation Coordination Model (REC)

    Recreation coordination service delivery

  • BehavioralComprehensive Model (COMP)

    a comprehensive service delivery model consisting of PRMHLTH plus REC.

06

What researchers measure

Primary outcomes

  1. Increased linkages between low income families and established services in their communities

    Time frame: Baseline, 12-month, 24-month, 36-month follow-up

07

Study locations

1 site
  • Alberta Human Resources and Employment
    Edmonton, Alberta T5A 1C6, Canada
08

References and documents

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. PubMed 11762894 ↗
  • 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. PubMed 27449358 ↗
  • 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. PubMed 24885729 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00705328
Responsible party
Maria Mayan (Vice Provost - Health Sciences Council; Professor - Nursing, University of Alberta) — Principal investigator
First posted
Jun 26, 2008
Start date
Dec 2005
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Apr 21, 2016

Study contacts

Jane Drummond, PhD
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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