Family Intervention Following Traumatic Injury

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effectiveness of a manualized intervention (FITS) to families living with brain injury or spinal cord injury. The intervention will be provided by a trained neuropsychologist and consists of 8 structured sessions of 90 minutes duration. The intervention group will be compared to a control group receiving treatment as usual, one psycho-educational group session of a 2 hour duration.

Official Title
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Effect of a Manualized Family Intervention Following Brain Injury or Spinal Cord Injury

Conditions
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Acquired Brain Injury, Spinal Cord Injuries

Intervention / Treatment
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* Behavioral: Group session psycho-education
* Behavioral: FITS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acquired brain injury or spinal cord injury Talk and read Danish Minimum 6 months to 2 years since discharge Family members must be actively involved in the patient's rehabilitation Exclusion Criteria: Severe aphasia Families, where other family members require a substantial amount of care Prior psychiatric or neurological disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SCI intervention<br>Spinal cord injury intervention group | Behavioral: FITS<br>* Manualized family intervention<br>|
| Active Comparator: SCI control<br>Spinal cord injury control | Behavioral: Group session psycho-education<br>* Active comparator - control group<br>|
| Experimental: TBI intervention<br>Traumatic brain injury intervention group | Behavioral: FITS<br>* Manualized family intervention<br>|
| Active Comparator: TBI control<br>Traumatic brain injury control group | Behavioral: Group session psycho-education<br>* Active comparator - control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease specific quality of life | Measured by Qolibri for patients with traumatic brain injury. The QOLIBRI consists of six novel items that assess overall satisfaction with facets of life relevant to people with TBI. Areas covered by the questionnaire include physical condition, cognition, emotions, function in daily life, personal and social life, and current situation and future prospects. Responses to each item are scored 1 ('Not at all') to 5 ('Very'), and the sum of all items was converted arithmetically to a percentage scale, with 0 representing the lowest possible HRQoL on the questionnaire and 100 the best possible HRQoL. | Change from day 0 to week 8, follow up at six months | 
| Generic quality of life | Short Form-36 (SF-36) completed by all participants. SF-36, a measure of self-reported HRQoL. The questionnaire comprises 36 items addressing eight dimensions of health: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health. The original summative scoring algorithm will be used, and raw scores will be converted into standard SF-36 scores ranging from 0-100 by calculating the product 100∗(actual sum score / highest possible score), with higher scores indicating better health. The scores will be evaluated according to Danish norms provided by Bjorner, Damsga°rd, Watt, and Bech (1997). This normative study showed high Cronbach's alpha coefficients on all the sub-scales ranging from .75-.85 (Bjorner et al., 1997). | Change from day 0 to week 8, follow up at six months | 
| Disease specific quality of life | QoL basic data elements for spinal cord injury for patients with spinal cord injury. The QoL Basic Data Set consists of three items on satisfaction with life as a whole, satisfaction with physical health and satisfaction with psychological health during the past 4 weeks. Each item is answered on a 0-10 numerical rating scale with markers 'complete dissatisfaction' and 'complete satisfaction'. | Change from day 0 to week 8, follow up at six months | 
| Caregiver burden | Caregiver burden questionnaire. The burden of the caregivers will be assessed using the 22-item scale Caregiver Burden (CB). The scale consists of five sub-scales: General Strain, Isolation, Disappointment, Emotional Involvement and Environment. A Total Burden index is given by calculating the mean of all 22 items. Each of the 22-items is scored 1-4 (Not at all, Seldom, Sometimes, Often) and the items cover aspects such as caregiver health, psychological well-being, relationship, social network, physical workload and environmental aspects. | Change from day 0 to week 8, follow up at six months | 
| Self-perceived burden | Burden perceived by the patient (SPB). The patients' SPB was measured with the Danish version of Self-Perceived Burden Scale (SPBS), which contains 10 items and scores range from 0-50. The 10 items were selected based on one single, general burden factor (Cousineau et al. 2003). Higher scores indicate high SPB. To estimate how severe self-perceived burden did patients feel, SPBS scores can be categorised into four stages: none to little (≤ 19), mild to moderate (20-29),moderate to severe (30-39) and severe (≥40). | Change from day 0 to week 8, follow up at six months |