Family Centered Intervention After Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Behavioral: The Traumatic Brain Injury Family System Intervention.; Behavioral: Psycho-educational session at OUH

• Registration Number: NCT03000400
• Lead Sponsor: Oslo University Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-11
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-22
• Study Start: 2017-01
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	The Traumatic Brain Injury Family System Intervention.	Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention.
Control group	Psycho-educational session at OUH	Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH).

Primary Outcome Measures

Name	Time	Method
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention	Mental health for all study participants
Change in Caregiver Burden Scale (CBS)	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention	Caregiver Burden for the family members

Secondary Outcome Measures

Name	Time	Method
Quality of Life after Traumatic Brain Injury (QOLIBRI)	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention	Quality of Life for the patients
Faces IV	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention	Family dynamics for all study participants

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway