Family Intervention Following Traumatic Injury (FITS)

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries; Acquired Brain Injury
• Intervention / Treatment: Behavioral: FITS; Behavioral: Group session psycho-education

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Hvidovre, Denmark, 2650
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: The Danish Victims Fund; The Association of Eastern Founders
• Investigators: Study Chair: Pernille Langer Soendergaard, MSc, Rigshospitalet, Denmark

Publications and helpful links

General Publications

• Stevens LF, Lehan T, Duran MAS, Plaza SLO, Arango-Lasprilla JC. Pilot Study of a Newly Developed Intervention for Families Facing Serious Injury. Top Spinal Cord Inj Rehabil. 2016 Winter;22(1):49-59. doi: 10.1310/sci2201-49.
• Soendergaard PL, Wolffbrandt MM, Biering-Sorensen F, Nordin M, Schow T, Arango-Lasprilla JC, Norup A. A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial. Trials. 2019 Nov 27;20(1):646. doi: 10.1186/s13063-019-3794-5. Erratum In: Trials. 2019 Dec 27;20(1):771.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Spinal Cord Diseases; Brain Injuries; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: 2018_0004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No