Family Centered Intervention After Traumatic Brain Injury

Study Overview
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Brief Summary
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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).

Official Title
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The Family as a Resource for Improving Patient and Family Functioning After Traumatic Brain Injury. A Randomized Controlled Trial of a Family Centered Intervention

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: The Traumatic Brain Injury Family System Intervention.
* Behavioral: Psycho-educational session at OUH


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention. | Behavioral: The Traumatic Brain Injury Family System Intervention.<br>* Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.<br>|
| Active Comparator: Control group<br>Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH). | Behavioral: Psycho-educational session at OUH<br>* 2.5 hour psycho-educational session for the patient's family members.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Form 36 Health Survey (SF-36) Mental Component Summary | Mental health for all study participants | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | 
| Change in Caregiver Burden Scale (CBS) | Caregiver Burden for the family members | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life after Traumatic Brain Injury (QOLIBRI) | Quality of Life for the patients | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention | 
| Faces IV | Family dynamics for all study participants | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention |