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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):

November 11, 2016
December 22, 2016
May 11, 2017
January 2017
December 2018   (Final data collection date for primary outcome measure)
  • 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
  • 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
  • Change in SF-36 Mental Component Summary [ Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after compeltion of the intervention ]
    Mental health for all study participants
  • Change in Caregiver Burden Scale (CBS) [ Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after compeltion of the intervention ]
    Caregiver Burden for the family members
Complete list of historical versions of study NCT03000400 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • Quality of Life after Traumatic Brain Injury (QOLIBRI) [ Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after compeltion of the intervention ]
    Quality of Life for the patients
  • Faces IV [ Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after compeltion of the intervention ]
    Family dynamics for all study participants
  • 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
  • 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
  • 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
  • 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
  • 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
  • Resilience Scale for Adults (RSA) [ Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after compeltion of the intervention ]
    Resilience for all study participants
  • The Generalized Self-Efficacy Scale [ Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after compeltion of the intervention ]
    Self-efficacy for all participants
  • The TBI Self-Efficacy Scale [ Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after compeltion of the intervention ]
    Self-efficacy for the patients
  • Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after compeltion of the intervention ]
    Mental health for all participants
  • The Generalized Anxiety Disorder 7 (GAD-7) [ Time Frame: Baseline at study start, at 8 weeks after inclusion, 6 months after compeltion of the intervention ]
    Mental health for all participants
 
Family Centered Intervention After Traumatic Brain Injury
The Family as a Resource for Improving Patient and Family Functioning After Traumatic Brain Injury. A Randomized Controlled Trial of a Family Centered Intervention
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).
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
  • 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.
  • Behavioral: Psycho-educational session at OUH
    2.5 hour psycho-educational session for the patient's family members.
  • Experimental: Intervention group
    Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention.
    Intervention: Behavioral: The Traumatic Brain Injury Family System Intervention.
  • Active Comparator: Control group
    Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH).
    Intervention: Behavioral: Psycho-educational session at OUH
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2019
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
No
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
Norway
 
 
NCT03000400
2016/1215/REK sør-øst C
No
Not Provided
Not Provided
Helene Lundgaard Søberg, Oslo University Hospital
Oslo University Hospital
  • Norwegian Extra Foundation for Health and Rehabilitation
  • The National Association for the Traumatically Injured, Norway
  • Baerum municipality, Department of Rehablitation, Norway
Principal Investigator: Helene L. Soberg, PhD Oslo University Hospital
Oslo University Hospital
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP