Family Centered Intervention After Traumatic Brain Injury

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

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).

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: The Traumatic Brain Injury Family System Intervention.; Behavioral: Psycho-educational session at OUH

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients: Home dwelling individuals age 16-65 who have sustained a TBI and receiving health services. They should:

1. Be out of post traumatic amnesia for at least one month
2. Have been discharged from post-acute rehabilitation in the specialized health care system in the last 6 - 18 months
3. Have a Ranchos Los Amigos Scale score of at least 8

4. Mini Mental Status Examination score >23

   • Family members: individuals related by blood or marriage/cohabitating with the TBI patient.

     1. Belongs to the same household as the individual with TBI and/or in close relation with the patient
     2. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.; Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.
Active Comparator: Control group; Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH).	Behavioral: Psycho-educational session at OUH; 2.5 hour psycho-educational session for the patient's family members.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• 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
• Investigators: Principal Investigator: Helene L. Soberg, PhD, Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: November 11, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: November 2, 2020
• Last Verified: November 1, 2020

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; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 2016/1215/REK sør-øst C