Family Centered Intervention After Traumatic Brain Injury

University of Oslo (UIO)

Status: Completed

Conditions: Traumatic Brain Injury

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03000400

2016/1215/REK sør-øst C

Details and patient eligibility

About

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).

Enrollment: 136 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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136 participants in 2 patient groups

Intervention group

Experimental group

Description:

Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention.

Treatment:

Behavioral: The Traumatic Brain Injury Family System Intervention.

Control group

Active Comparator group

Description:

Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH).

Treatment:

Behavioral: Psycho-educational session at OUH