Clinical trial NCT02161913: Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
Official title: Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: St. Luke's Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Washington State University
name: The Craig H. Neilsen Foundation
First posted: 2014-06-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* For Person with SCI: quadriplegia or paraplegia due to an acquired injury with complete or incomplete lesion as defined by ASIA
* For person with SCI: discharge from inpatient rehabilitation within the previous 3 years
* For Person with SCI: age 18 years or older
* For Person with SCI: mobility impairment as the result of the SCI
* For Person with SCI: living in the community in a non-group setting after injury
* For Person with SCI: planning to remain in the geographic area for at least 12 months
* For Person with SCI: competency in English
* For Caregiver of Person with SCI: provision of instrumental or emotional support for a spouse, relative, partner, or friend with SCI for at least the past 6 months
* For Caregiver of Person with SCI: having regular contact with the individual with SCI (at least a minimum of 2 hours face-to-face contact per week)
* For Caregiver of Person with SCI: living with or near the individual with SCI
* For Caregiver of Person with SCI: over the age of 18
* For Caregiver of Person with SCI: having a telephone
* For Caregiver of Person with SCI: planning to remain in the geographic area for at least 12 months
* For Caregiver of Person with SCI: competency in English

Exclusion Criteria:

* For Person with SCI or Caregiver: terminal illness with life expectancy of less than 12 months
* For Person with SCI or Caregiver: in active treatment for cancer
* For Person with SCI or Caregiver: blind or deaf
* For Person with SCI or Caregiver: moderate to severe cognitive impairment (defined at screening as a score on the Short Portable Mental Status Questionnaire \> 4 errors)
* For Person with SCI or Caregiver: severely high level of depression symptoms (defined at screening as a score on the CES-D \>30)

Primary outcomes:
measure: Change in ability to take action to improve one's health from baseline to end of treatment
timeFrame: 9 months
measure: Change in emotion regulation and interpersonal skills from baseline to end of treatment
timeFrame: 9 months
measure: Change in mental health and health behavior from baseline to end of treatment
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
measure: Change in ability to take action to improve one's health from baseline to 6-months post-treatment
timeFrame: 15 months
measure: Change in emotion regulation and interpersonal skills from baseline to 6-months post-treatment
timeFrame: 15 months
measure: Change in mental health and health behavior from baseline to 6-months post-treatment
timeFrame: 15 months
Locations:
city: Spokane
country: United States
facility: St. Luke's Rehabilitation Institute
state: Washington
Study officials:
affiliation: Washington State University
name: Dennis G. Dyck, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Rehabilitation Institute
name: Douglas L. Weeks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dyck DG, Weeks DL, Smith CL, Shaw M. Multiple family group intervention for spinal cord injury: Quantitative and qualitative comparison with standard education. J Spinal Cord Med. 2021 Jul;44(4):572-582. doi: 10.1080/10790268.2019.1710946. Epub 2020 Jan 21.
citation: Dyck DG, Weeks DL, Gross S, Lederhos Smith C, Lott HA, Wallace AJ, Wood SM. Comparison of two psycho-educational family group interventions for improving psycho-social outcomes in persons with spinal cord injury and their caregivers: a randomized-controlled trial of multi-family group intervention versus an active education control condition. BMC Psychol. 2016 Jul 26;4(1):40. doi: 10.1186/s40359-016-0145-0.