Family Centered Intervention After Traumatic Brain Injury

November 2, 2020 updated by: Helene Lundgaard Søberg, Oslo University Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
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)
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
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)
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Quality of Life for the patients
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Faces IV
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
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)
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
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
Time Frame: 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
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
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)
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
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)
Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Mental health for all participants
Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • 2016/1215/REK sør-øst C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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