Family Centered Intervention After Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03000400
• Other study ID #: 2016/1215/REK sør-øst C
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2020

Study information

• Verified date: November 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

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.
• Psycho-educational session at OUH
2.5 hour psycho-educational session for the patient's family members.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Baerum municipality, Department of Rehablitation, Norway, Norwegian Extra Foundation for Health and Rehabilitation, The National Association for the Traumatically Injured, Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Resilience Scale for Adults (RSA)	Resilience for all study participants	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other	The Generalized Self-Efficacy Scale	Self-efficacy for all participants	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other	The TBI Self-Efficacy Scale	Self-efficacy for the patients	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other	Patient Health Questionnaire 9 (PHQ-9)	Mental health for all participants	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Other	The Generalized Anxiety Disorder 7 (GAD-7)	Mental health for all participants	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Primary	Change in Short Form 36 Health Survey (SF-36) Mental Component Summary	Mental health for all study participants	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Primary	Change in Caregiver Burden Scale (CBS)	Caregiver Burden for the family members	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Secondary	Quality of Life after Traumatic Brain Injury (QOLIBRI)	Quality of Life for the patients	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Secondary	Faces IV	Family dynamics for all study participants	Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention