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A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial

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@article{d100688b52a5419e99785aa5f9b75ce1,
title = "A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord: a study protocol of a randomized controlled trial",
abstract = "BACKGROUND: Acquiring a traumatic injury constitutes a severe life change for the survivor, but also for the surrounding family. The paradigm of helping the family has primarily been on psychosocial interventions targeting caregivers. However, interventions including both survivor and caregivers should be an essential part of treatment, as the whole family's functional level and mental health can be affected. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). The objectives are to investigate if the intervention improves quality of life (QoL) and decreases burden. It is hypothesized that the family intervention improves problem-solving strategies and family dynamics, which will reduce the burden. This may improve the caregivers' mental health, which will improve the support to the survivor and QoL.METHODS: The study is an interventional, two-arm, randomized controlled trial. During a 2-year period, a total of 132 families will be included. Participants will be recruited from East-Denmark. Inclusion criteria are (1) TBI or tSCI, (2) ≥ 18 years of age, (3) ≥ 6 months to ≤ 2 years since discharge from hospital, (4) ability to understand and read Danish, (5) cognitive abilities that enable participation, and (6) a minimum of one family member actively involved in the survivor's life. Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence. Within each disease group, families will be allocated randomly to participate in an intervention or a control group with a ratio 1:1. The intervention groups receive the family intervention consisting of eight sessions of 90 min duration. Families in the control groups receive 2 h of psychoeducation. All participants complete questionnaires on QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience at pre-intervention, post-intervention, and 6-month follow up.CONCLUSION: If the intervention is found to have effect, the study will contribute with novel knowledge on the use of a manual-based intervention including the entire family. This would be of clinical interest and would help families living with the consequences of TBI or tSCI.TRIALS REGISTRATION: ClinicalTrials.gov, NCT03814876. Retrospectively registered on 24 January 2019.",
keywords = "CONSORT-SPI 2018, Family intervention, Randomized controlled trial, Study protocol, Traumatic brain injury, Traumatic spinal cord injury",
author = "Soendergaard, {Pernille Langer} and Wolffbrandt, {Mia Moth} and Fin Biering-S{\o}rensen and Malin Nordin and Trine Schow and Arango-Lasprilla, {Juan Carlos} and Anne Norup",
year = "2019",
month = "11",
day = "27",
doi = "10.1186/s13063-019-3794-5",
language = "English",
volume = "20",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - A manual-based family intervention for families living with the consequences of traumatic injury to the brain or spinal cord

T2 - a study protocol of a randomized controlled trial

AU - Soendergaard, Pernille Langer

AU - Wolffbrandt, Mia Moth

AU - Biering-Sørensen, Fin

AU - Nordin, Malin

AU - Schow, Trine

AU - Arango-Lasprilla, Juan Carlos

AU - Norup, Anne

PY - 2019/11/27

Y1 - 2019/11/27

N2 - BACKGROUND: Acquiring a traumatic injury constitutes a severe life change for the survivor, but also for the surrounding family. The paradigm of helping the family has primarily been on psychosocial interventions targeting caregivers. However, interventions including both survivor and caregivers should be an essential part of treatment, as the whole family's functional level and mental health can be affected. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). The objectives are to investigate if the intervention improves quality of life (QoL) and decreases burden. It is hypothesized that the family intervention improves problem-solving strategies and family dynamics, which will reduce the burden. This may improve the caregivers' mental health, which will improve the support to the survivor and QoL.METHODS: The study is an interventional, two-arm, randomized controlled trial. During a 2-year period, a total of 132 families will be included. Participants will be recruited from East-Denmark. Inclusion criteria are (1) TBI or tSCI, (2) ≥ 18 years of age, (3) ≥ 6 months to ≤ 2 years since discharge from hospital, (4) ability to understand and read Danish, (5) cognitive abilities that enable participation, and (6) a minimum of one family member actively involved in the survivor's life. Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence. Within each disease group, families will be allocated randomly to participate in an intervention or a control group with a ratio 1:1. The intervention groups receive the family intervention consisting of eight sessions of 90 min duration. Families in the control groups receive 2 h of psychoeducation. All participants complete questionnaires on QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience at pre-intervention, post-intervention, and 6-month follow up.CONCLUSION: If the intervention is found to have effect, the study will contribute with novel knowledge on the use of a manual-based intervention including the entire family. This would be of clinical interest and would help families living with the consequences of TBI or tSCI.TRIALS REGISTRATION: ClinicalTrials.gov, NCT03814876. Retrospectively registered on 24 January 2019.

AB - BACKGROUND: Acquiring a traumatic injury constitutes a severe life change for the survivor, but also for the surrounding family. The paradigm of helping the family has primarily been on psychosocial interventions targeting caregivers. However, interventions including both survivor and caregivers should be an essential part of treatment, as the whole family's functional level and mental health can be affected. The current study protocol presents a manualized family intervention for families living with traumatic injury to the brain (TBI) or spinal cord (tSCI). The objectives are to investigate if the intervention improves quality of life (QoL) and decreases burden. It is hypothesized that the family intervention improves problem-solving strategies and family dynamics, which will reduce the burden. This may improve the caregivers' mental health, which will improve the support to the survivor and QoL.METHODS: The study is an interventional, two-arm, randomized controlled trial. During a 2-year period, a total of 132 families will be included. Participants will be recruited from East-Denmark. Inclusion criteria are (1) TBI or tSCI, (2) ≥ 18 years of age, (3) ≥ 6 months to ≤ 2 years since discharge from hospital, (4) ability to understand and read Danish, (5) cognitive abilities that enable participation, and (6) a minimum of one family member actively involved in the survivor's life. Exclusion criteria are (1) active substance abuse, (2) aphasia, (3) prior neurologic or psychiatric diagnose, and (4) history of violence. Within each disease group, families will be allocated randomly to participate in an intervention or a control group with a ratio 1:1. The intervention groups receive the family intervention consisting of eight sessions of 90 min duration. Families in the control groups receive 2 h of psychoeducation. All participants complete questionnaires on QoL, self-perceived burden, family dynamics, problem-solving strategies, mental health, and resilience at pre-intervention, post-intervention, and 6-month follow up.CONCLUSION: If the intervention is found to have effect, the study will contribute with novel knowledge on the use of a manual-based intervention including the entire family. This would be of clinical interest and would help families living with the consequences of TBI or tSCI.TRIALS REGISTRATION: ClinicalTrials.gov, NCT03814876. Retrospectively registered on 24 January 2019.

KW - CONSORT-SPI 2018

KW - Family intervention

KW - Randomized controlled trial

KW - Study protocol

KW - Traumatic brain injury

KW - Traumatic spinal cord injury

UR - http://www.scopus.com/inward/record.url?scp=85075720318&partnerID=8YFLogxK

U2 - 10.1186/s13063-019-3794-5

DO - 10.1186/s13063-019-3794-5

M3 - Journal article

VL - 20

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 646

ER -

ID: 58502871