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

BACKGROUND: Families with low incomes experience an array of health and social challenges that compromise their resilience and lead to negative family outcomes. Along with financial constraints, there are barriers associated with mental and physical health, poorer education and language. In addition, vulnerable populations experience many services as markedly unhelpful. This combination of family and service barriers results in reduced opportunities for effective, primary-level services and an increased use of more expensive secondary-level services (e.g., emergency room visits, child apprehensions, police involvement). A systematic review of effective interventions demonstrated that promotion of physical and mental health using existing service was critically important. METHODS/DESIGN: The Families First Edmonton Trial (FFE) tests four service integration approaches to increase use of available health and social services for families with low-income. It is a randomized, two-factor, single-blind, longitudinal effectiveness trial where low-income families (1168) were randomly assigned to receive either (1) Family Healthy Lifestyle plus Family Recreation service integration (Comprehensive), (2) Family Healthy Lifestyle service integration, (3) Family Recreation service integration, or (4) existing services. To be eligible families needed to be receiving one of five government income assistance programs. The trial was conducted in the City of Edmonton between January 2006 and August 2011. The families were followed for a total of three years of which interventional services were received for between 18 and 24 months. The primary outcome is the number of family linkages to health and social services as measured by a customized survey tool “Family Services Inventory”. Secondary outcomes include type and satisfaction with services, cost of services, family member health, and family functioning. Where possible, the measures for secondary outcomes were selected because of their standardization, the presence of published norming data, and their utility as comparators to other studies of low-income families. As an effectiveness trial, community and government partners participated in all committees through a mutually agreed upon governance model and helped manage and problem solve with researchers. DISCUSSION: Modifications were made to the FFE trial based on the pragmatics of community-based trials. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT0070532