Comparison of Two Psycho-educational Family Group Interventions for

Status Completed

Clinical Trial Summary

Each year over 12,000 spinal cord injuries (SCI) occur in the United States. These injuries result in incredibly difficult, long-term, life adjustments both for patients and their caregivers. Many families continue to struggle with the physical, emotional and social impacts of SCI for months and years after the injury. Family education and support improves the outcomes of other challenging long-term conditions such as Traumatic Brain Injury, but little effort has been made to provide such interventions for persons with SCI and their caregivers. The proposed study will address this problem by refining and testing a group treatment for SCI called Multi-family Group (MFG) intervention. The groups will include people with SCI and their primary caregivers, and will be facilitated by an "educator" who is a health care provider who works with people with SCI. By providing education about the management of SCI and support in an MFG format, quality of life for persons with SCI is predicted to be improved. In turn, it is expected that caregivers will also benefit from the information, problem-solving activities, and social support that they receive from the educators and other group members. The investigators will recruit 32 individuals with SCI who have been discharged from inpatient rehabilitation within the previous three years and their primary caregivers. Participants will be randomized to the MFG intervention or to an education control condition and tested before and after treatment and 6 months following treatment. It is hypothesized that participants receiving MFG-SCI will have better outcomes than controls on measures of quality of life, health, and adjustment. The study will also test whether participants who are more recently discharged from inpatient rehabilitation will experience greater benefit from the MFG intervention or the education control intervention. If the outcomes support the hypotheses, the MFG intervention should be made available to those with SCI and their caregivers.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02161913
Study type	Interventional
Source	St. Luke's Rehabilitation Institute
Contact
Status	Completed
Phase	N/A
Start date	September 2014
Completion date	April 2019

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms