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Family Centered Intervention After Traumatic Brain Injury

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ClinicalTrials.gov Identifier: NCT03000400
Recruitment Status : Recruiting
First Posted : December 22, 2016
Last Update Posted : May 11, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment
Traumatic Brain Injury Behavioral: The Traumatic Brain Injury Family System Intervention. Behavioral: Psycho-educational session at OUH

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients: Home dwelling individuals age 16-65 who have sustained a TBI and receiving health services in the municipalities. 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
      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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03000400


Contacts
Contact: Mari Storli Rasmussen, PhD student +47 99 79 75 75 masras@ous-hf.no
Contact: Helene L. Soberg, PhD + 47 95109637 h.l.soberg@medisin.uio.no

Locations
Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Helene Soberg, PhD       h.l.soberg@medisin.uio.no   
Contact: Mari Rasmussen    +47 99 79 75 75    masras@ous-hf.no   
Sponsors and Collaborators
Oslo University Hospital
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
More Information

Responsible Party: Helene Lundgaard Søberg, Senior researcher, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03000400     History of Changes
Other Study ID Numbers: 2016/1215/REK sør-øst C
First Posted: December 22, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System