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Families First Edmonton (FFE) (FFE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00705328
Recruitment Status : Completed
First Posted : June 26, 2008
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Low-Income Population Behavioral: Primary Health Care Model (PRMHLTH) Behavioral: Recreation Coordination Model (REC) Behavioral: Comprehensive Model (COMP) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: Families First Edmonton: The Comparative Effects and Expense of Four Models of Augmenting Services for Low-income Families
Study Start Date : December 2005
Primary Completion Date : June 2011
Study Completion Date : June 2011
Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Behavioral: Primary Health Care Model (PRMHLTH)
Primary health care service delivery
Experimental: 2 Behavioral: Recreation Coordination Model (REC)
Recreation coordination service delivery
Experimental: 3 Behavioral: Comprehensive Model (COMP)
a comprehensive service delivery model consisting of PRMHLTH plus REC.


Outcome Measures

Primary Outcome Measures :
  1. Increased linkages between low income families and established services in their communities [ Time Frame: Baseline, 12-month, 24-month, 36-month follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705328


Locations
Canada, Alberta
Alberta Human Resources and Employment
Edmonton, Alberta, Canada, T5A 1C6
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Jane Drummond, PhD University of Alberta
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Mayan, Vice Provost - Health Sciences Council; Professor - Nursing, University of Alberta
ClinicalTrials.gov Identifier: NCT00705328     History of Changes
Other Study ID Numbers: 137444
First Posted: June 26, 2008    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Maria Mayan, University of Alberta:
low-income families
children
recreation
family healthy lifestyle
linkages to community resources
Families with low incomes
working poor
welfare recipients