The Family as a Resource for Improving Patient and Family Functioning After Traumatic Brain Injury. A Randomized Controlled Trial of a Family Centered Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- Change in Short Form 36 Health Survey (SF-36) Mental Component Summary
Study Overview
Brief Summary
The purpose of this study is to determine the effectiveness of a multi-professional theoretically based family centered intervention, The Traumatic Brain Injury Family System Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics and functioning. The intervention will be provided in collaboration with the municipal rehabilitation service. The intervention group will be compared with a control group receiving treatment as usual, defined as an individually tailored multidisciplinary approach, and the family members will attend one ongoing psycho-educational group session of 2.5 hour provided by Oslo University Hospital (OUH).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients: Home dwelling individuals age 16-65 who have sustained a TBI and receiving health services. They should:
- •Be out of post traumatic amnesia for at least one month
- •Have been discharged from post-acute rehabilitation in the specialized health care system in the last 6 - 18 months
- •Have a Ranchos Los Amigos Scale score of at least 8
- •Mini Mental Status Examination score >23
- •Family members: individuals related by blood or marriage/cohabitating with the TBI patient.
- •Belongs to the same household as the individual with TBI and/or in close relation with the patient
- •are between 18-65 years of age.
Exclusion Criteria
- •TBI survivors or their family members with a history of psychiatric or neurologic illness, active learning disability, or active substance abuse. Inability to speak and read Norwegian. Families in which there are other members requiring care or who have previously been caregivers for other family members.
Outcomes
Primary Outcomes
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Mental health for all study participants
Change in Caregiver Burden Scale (CBS)
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Caregiver Burden for the family members
Secondary Outcomes
- Quality of Life after Traumatic Brain Injury (QOLIBRI)(Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention)
- Faces IV(Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention)
Investigators
Helene Lundgaard Søberg
Senior researcher
Oslo University Hospital