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

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161913
• Other study ID #: CHNF-288318
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: St. Luke's Rehabilitation Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Behavioral:
• Multi-Family Group Treatment

• SCI Education Control Group

Locations

Country	Name	City	State
United States	St. Luke's Rehabilitation Institute	Spokane	Washington

Sponsors (3)

Lead Sponsor	Collaborator
St. Luke's Rehabilitation Institute	The Craig H. Neilsen Foundation, Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in ability to take action to improve one's health from baseline to 6-months post-treatment	Ability to take action to improve one's health will be assessed with the Patient Activation Measure (PAM) and the 8-item Short-Form Health Survey (SF-8). The PAM will measure the degree of individual's knowledge, confidence, and skill to participate in self-management. A higher degree of patient activation has been associated with better health outcomes for adults with chronic conditions. The SF-8 will assess self-reported general health, physical functioning, role-limitations due to physical health problems, bodily pain, and vitality.	15 months
Other	Change in emotion regulation and interpersonal skills from baseline to 6-months post-treatment	Emotion regulation and interpersonal skills will be assessed with the Anger Expression Scale (AXS), the Abbreviated Duke Social Support Index (ADSSI), and the Family Crisis Oriented Personal Evaluation Scales (F-COPES). The AXS measures anger management including anger-in (suppression of angry feelings), anger-out (expression of anger towards property or people) and anger control (the frequency of attempts to control expressions of anger). The ADSSI measures both subjective support and social network interactions. The F-COPES assesses family-level coping including use of social/spiritual support, reframing negative events, and mobilizing the family to acquire/accept help.	15 months
Other	Change in mental health and health behavior from baseline to 6-months post-treatment	Mental health and health behavior will be assessed for the presence and severity of depressive symptoms, substance use, and in caregivers, burden of care, as these may influence benefits derived from treatment. The 10-item Center for Epidemiologic Study of Depression (CESD-10) will measure depressive symptoms, and the Addiction Severity Index-Lite (ASI-L) will evaluate alcohol and substance use and related problems. The Caregiver Burden Inventory (CBI) will evaluate caregiver burden in four areas: physical, social, emotional and time dependence burden.	15 months
Primary	Change in ability to take action to improve one's health from baseline to end of treatment	Ability to take action to improve one's health will be assessed with the Patient Activation Measure (PAM) and the 8-item Short-Form Health Survey (SF-8). The PAM will measure the degree of individual's knowledge, confidence, and skill to participate in self-management. A higher degree of patient activation has been associated with better health outcomes for adults with chronic conditions. The SF-8 will assess self-reported general health, physical functioning, role-limitations due to physical health problems, bodily pain, and vitality.	9 months
Primary	Change in emotion regulation and interpersonal skills from baseline to end of treatment	Emotion regulation and interpersonal skills will be assessed with the Anger Expression Scale (AXS), the Abbreviated Duke Social Support Index (ADSSI), and the Family Crisis Oriented Personal Evaluation Scales (F-COPES). The AXS measures anger management including anger-in (suppression of angry feelings), anger-out (expression of anger towards property or people) and anger control (the frequency of attempts to control expressions of anger). The ADSSI measures both subjective support and social network interactions. The F-COPES assesses family-level coping including use of social/spiritual support, reframing negative events, and mobilizing the family to acquire/accept help.	9 months
Primary	Change in mental health and health behavior from baseline to end of treatment	Mental health and health behavior will be assessed for the presence and severity of depressive symptoms, substance use, and in caregivers, burden of care, as these may influence benefits derived from treatment. The 10-item Center for Epidemiologic Study of Depression (CESD-10) will measure depressive symptoms, and the Addiction Severity Index-Lite (ASI-L) will evaluate alcohol and substance use and related problems. The Caregiver Burden Inventory (CBI) will evaluate caregiver burden in four areas: physical, social, emotional and time dependence burden.	9 months