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

NCT ID: NCT02161913

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-04-30

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.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCI Education Control Group

The SCIEC condition is a 16-session, highly structured educational intervention that provides information on how SCI affects the body; methods for maximizing function, coping, and living with SCI; and staying healthy with SCI. It also includes general guidelines for improving health behavior. Each SCIEC session follows the same structure, beginning with a presentation of the objectives for the current session and a brief review of material from the previous session before introducing the session's topic and presenting information on one or two key problem areas. SCIEC utilizes a traditional didactic model with information delivered by an expert SCI educator in a classroom or lecture setting.

Group Type: ACTIVE_COMPARATOR

SCI Education Control Group

Intervention Type: BEHAVIORAL

Multi-family Group Treatment

The MFG Program uses a structured problem-solving and skills training program to provide participants with SCI and their caregivers with tools and information to improve coping and help family members to connect through positive behavioral exchanges. MFG educators are health professionals with experience in management of SCI, such as physical therapists, recreational therapists, occupational therapists, and psychologists. MFG will last for 16 sessions across 9 months.

Group Type: EXPERIMENTAL

Multi-Family Group Treatment

Intervention Type: BEHAVIORAL

Interventions

Multi-Family Group Treatment

Intervention Type: BEHAVIORAL

SCI Education Control Group

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington State University

OTHER

Sponsor Role: collaborator

The Craig H. Neilsen Foundation

OTHER

Sponsor Role: collaborator

St. Luke's Rehabilitation Institute

OTHER

Sponsor Role: lead

Responsible Party

Douglas L. Weeks

Director of Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis G. Dyck, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Douglas L. Weeks, PhD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Rehabilitation Institute

Locations

St. Luke's Rehabilitation Institute

Spokane, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31961284 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27457478 (View on PubMed)

Other Identifiers

CHNF-288318

Identifier Type: -

Identifier Source: org_study_id