Clinical trial NCT03000400: Family Centered Intervention After Traumatic Brain Injury
Official title: The Family as a Resource for Improving Patient and Family Functioning After Traumatic Brain Injury. A Randomized Controlled Trial of a Family Centered Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian Extra Foundation for Health and Rehabilitation
name: The National Association for the Traumatically Injured, Norway
name: Baerum municipality, Department of Rehablitation, Norway
First posted: 2016-12-22
Enrollment: 136
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

Patients: Home dwelling individuals age 16-65 who have sustained a TBI and receiving health services. They should:

1. Be out of post traumatic amnesia for at least one month
2. Have been discharged from post-acute rehabilitation in the specialized health care system in the last 6 - 18 months
3. Have a Ranchos Los Amigos Scale score of at least 8
4. Mini Mental Status Examination score \>23

   * Family members: individuals related by blood or marriage/cohabitating with the TBI patient.

     1. Belongs to the same household as the individual with TBI and/or in close relation with the patient
     2. 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.

Primary outcomes:
measure: Change in Short Form 36 Health Survey (SF-36) Mental Component Summary
timeFrame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
measure: Change in Caregiver Burden Scale (CBS)
timeFrame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Secondary outcomes:
measure: Quality of Life after Traumatic Brain Injury (QOLIBRI)
timeFrame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
measure: Faces IV
timeFrame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other outcomes:
measure: Resilience Scale for Adults (RSA)
timeFrame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
measure: The Generalized Self-Efficacy Scale
timeFrame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
measure: The TBI Self-Efficacy Scale
timeFrame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
measure: The Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Helene L. Soberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: