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Family Centered Intervention After Traumatic Brain Injury

NCT ID: NCT03000400

Last Updated: 2020-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-05-31

Brief Summary

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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

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Conditions

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Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

The Traumatic Brain Injury Family System Intervention.

Intervention Type BEHAVIORAL

Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.

Control group

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

Group Type ACTIVE_COMPARATOR

Psycho-educational session at OUH

Intervention Type BEHAVIORAL

2.5 hour psycho-educational session for the patient's family members.

Interventions

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The Traumatic Brain Injury Family System Intervention.

Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.

Intervention Type BEHAVIORAL

Psycho-educational session at OUH

2.5 hour psycho-educational session for the patient's family members.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian Extra Foundation for Health and Rehabilitation

OTHER

Sponsor Role collaborator

The National Association for the Traumatically Injured, Norway

UNKNOWN

Sponsor Role collaborator

Baerum municipality, Department of Rehablitation, Norway

UNKNOWN

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Helene Lundgaard Søberg

Senior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helene L. Soberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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Oslo University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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2016/1215/REK sør-øst C

Identifier Type: -

Identifier Source: org_study_id