<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03000400</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1215/REK sør-øst C</org_study_id>
    <nct_id>NCT03000400</nct_id>
  </id_info>
  <brief_title>Family Centered Intervention After Traumatic Brain Injury</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oslo University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Norwegian Extra Foundation for Health and Rehabilitation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The National Association for the Traumatically Injured, Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baerum municipality, Department of Rehablitation, Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oslo University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of a multi-professional&#xD;
      theoretically based family centered intervention, The Traumatic Brain Injury Family System&#xD;
      Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics&#xD;
      and functioning. The intervention will be provided in collaboration with the municipal&#xD;
      rehabilitation service. The intervention group will be compared with a control group&#xD;
      receiving treatment as usual, defined as an individually tailored multidisciplinary approach,&#xD;
      and the family members will attend one ongoing psycho-educational group session of 2.5 hour&#xD;
      provided by Oslo University Hospital (OUH).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">May 2020</completion_date>
  <primary_completion_date type="Actual">May 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Short Form 36 Health Survey (SF-36) Mental Component Summary</measure>
    <time_frame>Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention</time_frame>
    <description>Mental health for all study participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Caregiver Burden Scale (CBS)</measure>
    <time_frame>Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention</time_frame>
    <description>Caregiver Burden for the family members</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life after Traumatic Brain Injury (QOLIBRI)</measure>
    <time_frame>Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention</time_frame>
    <description>Quality of Life for the patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Faces IV</measure>
    <time_frame>Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention</time_frame>
    <description>Family dynamics for all study participants</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Resilience Scale for Adults (RSA)</measure>
    <time_frame>Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention</time_frame>
    <description>Resilience for all study participants</description>
  </other_outcome>
  <other_outcome>
    <measure>The Generalized Self-Efficacy Scale</measure>
    <time_frame>Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention</time_frame>
    <description>Self-efficacy for all participants</description>
  </other_outcome>
  <other_outcome>
    <measure>The TBI Self-Efficacy Scale</measure>
    <time_frame>Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention</time_frame>
    <description>Self-efficacy for the patients</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Health Questionnaire 9 (PHQ-9)</measure>
    <time_frame>Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention</time_frame>
    <description>Mental health for all participants</description>
  </other_outcome>
  <other_outcome>
    <measure>The Generalized Anxiety Disorder 7 (GAD-7)</measure>
    <time_frame>Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention</time_frame>
    <description>Mental health for all participants</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The Traumatic Brain Injury Family System Intervention.</intervention_name>
    <description>Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psycho-educational session at OUH</intervention_name>
    <description>2.5 hour psycho-educational session for the patient's family members.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients: Home dwelling individuals age 16-65 who have sustained a TBI and receiving health&#xD;
        services. They should:&#xD;
&#xD;
          1. Be out of post traumatic amnesia for at least one month&#xD;
&#xD;
          2. Have been discharged from post-acute rehabilitation in the specialized health care&#xD;
             system in the last 6 - 18 months&#xD;
&#xD;
          3. Have a Ranchos Los Amigos Scale score of at least 8&#xD;
&#xD;
          4. Mini Mental Status Examination score &gt;23&#xD;
&#xD;
               -  Family members: individuals related by blood or marriage/cohabitating with the&#xD;
                  TBI patient.&#xD;
&#xD;
                    1. Belongs to the same household as the individual with TBI and/or in close&#xD;
                       relation with the patient&#xD;
&#xD;
                    2. are between 18-65 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  TBI survivors or their family members with a history of psychiatric or neurologic&#xD;
             illness, active learning disability, or active substance abuse. Inability to speak and&#xD;
             read Norwegian. Families in which there are other members requiring care or who have&#xD;
             previously been caregivers for other family members.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helene L. Soberg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oslo University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oslo University Hospital</name>
      <address>
        <city>Oslo</city>
        <zip>0424</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oslo University Hospital</investigator_affiliation>
    <investigator_full_name>Helene Lundgaard Søberg</investigator_full_name>
    <investigator_title>Senior researcher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000400
org study id: 2016/1215/REK sør-øst C
nct id: NCT03000400
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
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
description: Mental health for all study participants
measure: Change in Caregiver Burden Scale (CBS)
time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
description: Caregiver Burden for the family members
measure: 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
description: Quality of Life for the patients
measure: Faces IV
time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
description: Family dynamics for all study participants
measure: Resilience Scale for Adults (RSA)
time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
description: Resilience for all study participants
measure: The Generalized Self-Efficacy Scale
time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
description: Self-efficacy for all participants
measure: The TBI Self-Efficacy Scale
time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
description: Self-efficacy for the patients
measure: Patient Health Questionnaire 9 (PHQ-9)
time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
description: Mental health for all participants
measure: 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
description: Mental health for all participants
arm group label: Intervention group
arm group type: Experimental
description: Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention.
arm group label: Control group
arm group type: Active Comparator
description: Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH).
intervention type: Behavioral
intervention name: The Traumatic Brain Injury Family System Intervention.
description: Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.
arm group label: Intervention group
intervention type: Behavioral
intervention name: Psycho-educational session at OUH
description: 2.5 hour psycho-educational session for the patient's family members.
arm group label: Control group
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Helene L. Soberg, PhD
role: Principal Investigator
affiliation: Oslo University Hospital
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Oslo University Hospital
investigator full name: Helene Lundgaard Søberg
investigator title: Senior researcher
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Wounds and Injuries