Background: Over 12,000 individuals suffer a spinal cord injury (SCI) annually in the United States, necessitating long-term, complex adjustments and responsibilities for patients and their caregivers. Despite growing evidence that family education and support improves the management of chronic conditions for care recipients as well as caregiver outcomes, few systematic efforts have been made to involve caregivers in psycho-educational interventions for SCI. As a result, a serious gap exists in accumulated knowledge regarding effective, family-based treatment strategies for improving outcomes for individuals with SCI and their caregivers. The proposed research aims to fill this gap by evaluating the efficacy of a structured adaptation of an evidence-based psychosocial group treatment called Multi-Family Group (MFG) intervention. The objective of this study is to test, in a randomized-controlled design, an MFG intervention for the treatment of individuals with SCI and their primary caregivers. Our central hypothesis is that by providing support in an MFG format, we will improve coping skills of persons with SCI and their caregivers as well as supportive strategies employed by caregivers.
Methods: We will recruit 32 individuals with SCI who have been discharged from inpatient rehabilitation within the previous 3 years and their primary caregivers. Patient/caregiver pairs will be randomized to the MFG intervention or an active SCI education control (SCIEC) condition in a two-armed randomized trial design. Participants will be assessed pre- and post-program and 6 months post-program. Intent to treat analyses will test two a priori hypotheses: (1) MFG-SCI will be superior to SCIEC for SCI patient activation, health status, and emotion regulation, caregiver burden and health status, and relationship functioning, and (2) MFG will be more effective for individuals with SCI and their caregivers when the person with SCI is within 18 months of discharge from inpatient rehabilitation compared to when the person is between 19 and 36 months post discharge.
Discussion: Support for our hypotheses will indicate that MFG-SCI is superior to specific education for assisting patients and their caregivers in the management of difficult, long-term, life adjustments in the months and years after SCI, with increased efficacy closer in time to the injury.
Trial registration: ClinicalTrials.gov NCT02161913 . Registered 10 June 2014.
Keywords: Caregiver; Multi-family group treatment; Psycho-educational intervention; Spinal cord injury; Study protocol.