Back to resultsFamily Centered Intervention After Traumatic Brain Injury
Primary Purpose
Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
The Traumatic Brain Injury Family System Intervention.
Psycho-educational session at OUH
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
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.
Sites / Locations
- Oslo University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention.
Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH).
Outcomes
Primary Outcome Measures
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary
Mental health for all study participants
Change in Caregiver Burden Scale (CBS)
Caregiver Burden for the family members
Secondary Outcome Measures
Quality of Life after Traumatic Brain Injury (QOLIBRI)
Quality of Life for the patients
Faces IV
Family dynamics for all study participants
Full Information
NCT ID
NCT03000400
First Posted
November 11, 2016
Last Updated
November 2, 2020
Sponsor
Oslo University Hospital
Collaborators
Norwegian Extra Foundation for Health and Rehabilitation, The National Association for the Traumatically Injured, Norway, Baerum municipality, Department of Rehablitation, Norway
1. Study Identification
Unique Protocol Identification Number
NCT03000400
Brief Title
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
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
Collaborators
Norwegian Extra Foundation for Health and Rehabilitation, The National Association for the Traumatically Injured, Norway, Baerum municipality, Department of Rehablitation, Norway
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH).
Intervention Type
Behavioral
Intervention Name(s)
The Traumatic Brain Injury Family System Intervention.
Intervention Description
Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.
Intervention Type
Behavioral
Intervention Name(s)
Psycho-educational session at OUH
Intervention Description
2.5 hour psycho-educational session for the patient's family members.
Primary Outcome Measure Information:
Title
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary
Description
Mental health for all study participants
Time Frame
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Title
Change in Caregiver Burden Scale (CBS)
Description
Caregiver Burden for the family members
Time Frame
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Secondary Outcome Measure Information:
Title
Quality of Life after Traumatic Brain Injury (QOLIBRI)
Description
Quality of Life for the patients
Time Frame
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Title
Faces IV
Description
Family dynamics for all study participants
Time Frame
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other Pre-specified Outcome Measures:
Title
Resilience Scale for Adults (RSA)
Description
Resilience for all study participants
Time Frame
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Title
The Generalized Self-Efficacy Scale
Description
Self-efficacy for all participants
Time Frame
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Title
The TBI Self-Efficacy Scale
Description
Self-efficacy for the patients
Time Frame
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Title
Patient Health Questionnaire 9 (PHQ-9)
Description
Mental health for all participants
Time Frame
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Title
The Generalized Anxiety Disorder 7 (GAD-7)
Description
Mental health for all participants
Time Frame
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene L. Soberg, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
0424
Country
Norway
12. IPD Sharing Statement
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Family Centered Intervention After Traumatic Brain Injury
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