Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001419358
Ethics application status
Approved
Date submitted
15/09/2017
Date registered
9/10/2017
Date last updated
8/03/2021
Date data sharing statement initially provided
8/03/2021
Date results provided
8/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
SKIBI – Supporting Kids In Brain Injury
Scientific title
Life altering effects on children when a family member has an Acquired Brain Injury; a qualitative exploration of child and family perceptions
Secondary ID [1] 292896 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SKIBI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 304740 0
Anxiety 304946 0
Condition category
Condition code
Mental Health 304072 304072 0 0
Anxiety
Injuries and Accidents 304271 304271 0 0
Other injuries and accidents
Neurological 304319 304319 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this research is to involve consumers, with a lived experience of Acquired Brain Injury (ABI), in how sub-acute Services can best support and educate children about brain injury. Qualitative interviews with children and family members will be the first phase of research which will aim at eliciting information about their lived experience of brain injury, any perceived lack of support/information and how services could have best supported their children. Experienced qualified social workers will undertake the interviews. Interviews are likely to take 30 minutes to one hour.
Intervention code [1] 299132 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303393 0
To investigate children and families perspective on their experience when a family member has a brain injury, assessed by qualitative interviews.
Timepoint [1] 303393 0
Time of interview
Secondary outcome [1] 338824 0
To understand if children perceive their needs were met as a significant other in the journey of a person with a brain injury, assessed by qualitative interviews.
Timepoint [1] 338824 0
NA
Secondary outcome [2] 339531 0
To gain information on children and families perceptions of the optimum support system that should be offered including what, how, when and where.
Timepoint [2] 339531 0
NA

Eligibility
Key inclusion criteria
Two groups of individuals will be interviewed, 1. the children who have experienced the journey with an adult who has had an ABI, and 2. the parents of children who have experienced this journey.
1. 20 children, between the ages of 5 and 17 years old, who have a close relationship with a person with an acquired brain injury will be interviewed

2. 10 parents of children who are close to a person with an ABI will be interviewed.
The age range of these participants will be older than 18 years.
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
People who are not interested in discussing issues relating to the query.
People who are likely to be traumatised by the interview material.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Qualitative thematic analysis will be undertaken with the assistance of NVivo 11 qualitative data analysis software package. Firstly, the summaries of each interview and focus group will undergo a preliminary analysis to identify the meaning in each unit of data for that person or group (open coding). As patterns emerge across the interviews and groups, data will be pooled according to similar meanings, perceptions and feelings and the initial nodes developed. In this way, subthemes will begin to emerge (axial coding). Next the subthemes will be combined to arrive at the major themes (selective coding). At each phase of analysis the three researchers (MK, KD and AB) will discuss the categories and group them into subthemes and then major themes until consensus is reached.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
9/10/2017
Actual
15/11/2017
Date of last participant enrolment
Anticipated
20/04/2018
Actual
21/06/2018
Date of last data collection
Anticipated
27/04/2018
Actual
21/06/2018
Sample size
Target
30
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9038 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 17519 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 297526 0
Government body
Name [1] 297526 0
Lifetime Support Authority
Country [1] 297526 0
Australia
Primary sponsor type
Government body
Name
South Australia Brain Injury Rehabilitation Services
Address
Hampstead Rehabilitation Centre
207-235 Hampstead Road, Lightsview SA 5085
Central Adelaide Local Health Network
Country
Australia
Secondary sponsor category [1] 296532 0
None
Name [1] 296532 0
Address [1] 296532 0
Country [1] 296532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298622 0
Womens and Childrens Ethics Committee SA
Ethics committee address [1] 298622 0
Ethics committee country [1] 298622 0
Australia
Date submitted for ethics approval [1] 298622 0
27/09/2016
Approval date [1] 298622 0
19/10/2016
Ethics approval number [1] 298622 0
HREC/16/WCHN/136

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77682 0
Dr Maggie Killington
Address 77682 0
South Australia Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085
Country 77682 0
Australia
Phone 77682 0
+61 400061204
Fax 77682 0
Email 77682 0
[email protected]
Contact person for public queries
Name 77683 0
Maggie Killington
Address 77683 0
South Australia Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085
Country 77683 0
Australia
Phone 77683 0
+ 61 400061204
Fax 77683 0
Email 77683 0
[email protected]
Contact person for scientific queries
Name 77684 0
Maggie Killington
Address 77684 0
South Australia Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085
Country 77684 0
Australia
Phone 77684 0
+61 400061204
Fax 77684 0
Email 77684 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD is not available.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseLife altering effects on children when a family member has an acquired brain injury; a qualitative exploration of child and family perceptions.2022https://dx.doi.org/10.1080/09638288.2020.1766582
N.B. These documents automatically identified may not have been verified by the study sponsor.