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Completed

NCT Number: NCT03000400

Family Centered Intervention After Traumatic Brain Injury

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).

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oslo University Hospital

Oslo, 0424, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Be out of post traumatic amnesia for at least one month
  • Have been discharged from post-acute rehabilitation in the specialized health care system in the last 6 - 18 months
  • Have a Ranchos Los Amigos Scale score of at least 8
  • Mini Mental Status Examination score >23
  • Family members: individuals related by blood or marriage/cohabitating with the TBI patient.
  • Belongs to the same household as the individual with TBI and/or in close relation with the patient
  • 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.

Treatment and study plan

The Traumatic Brain Injury Family System Intervention.

Behavioral

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

Psycho-educational session at OUH

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

Other outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Baerum municipality, Department of Rehablitation, Norway
  • Norwegian Extra Foundation for Health and Rehabilitation
  • The National Association for the Traumatically Injured, Norway

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 22, 2016
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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