Family Centered Intervention After Traumatic Brain Injury

NCT03000400 | Completed

• 1 other identifier: 2016/1215/REK sør-øst C
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Quality of Life after Traumatic Brain Injury (QOLIBRI)

  Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention

• Faces IV

  Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention

Other Outcomes (5)

• Resilience Scale for Adults (RSA)

  Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention

• The Generalized Self-Efficacy Scale

  Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention

• The TBI Self-Efficacy Scale

  Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Control group

ACTIVE COMPARATOR

Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH).

Behavioral: Psycho-educational session at OUH

Interventions

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.

Intervention group

Psycho-educational session at OUH BEHAVIORAL

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

Control group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Extra Foundation for Health and Rehabilitation: collaborator
• The National Association for the Traumatically Injured, Norway: collaborator
• Baerum municipality, Department of Rehablitation, Norway: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Helene L. Soberg, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: December 22, 2016
• Study Start: January 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Locations

NO (1)