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| Name | Class |
|---|---|
| Norwegian Extra Foundation for Health and Rehabilitation | OTHER |
| The National Association for the Traumatically Injured, Norway | UNKNOWN |
| Baerum municipality, Department of Rehablitation, Norway | UNKNOWN |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention. |
|
| Control group | Active Comparator | Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Traumatic Brain Injury Family System Intervention. | Behavioral | Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Resilience Scale for Adults (RSA) | Resilience for all study participants | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention |
| The Generalized Self-Efficacy Scale |
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helene L. Soberg, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0424 | Norway |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Psycho-educational session at OUH | Behavioral | 2.5 hour psycho-educational session for the patient's family members. |
|
Family dynamics for all study participants
| Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention |
Self-efficacy for all participants
| Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention |
| The TBI Self-Efficacy Scale | Self-efficacy for the patients | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention |
| Patient Health Questionnaire 9 (PHQ-9) | Mental health for all participants | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention |
| The Generalized Anxiety Disorder 7 (GAD-7) | Mental health for all participants | Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |