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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

SKIBI

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Acquired Brain Injury

Anxiety

Condition category

Condition code

Mental Health

Anxiety

Injuries and Accidents

Other injuries and accidents

Neurological

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]

Not applicable

Comparator / control treatment

None

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To investigate children and families perspective on their experience when a family member has a brain injury, assessed by qualitative interviews.

Timepoint [1]

Time of interview

Secondary outcome [1]

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]

Secondary outcome [2]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Lifetime Support Authority

Address [1]

Lifetime Support Authority
PO Box 1218,
Adelaide SA 5000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Womens and Childrens Ethics Committee SA

Ethics committee address [1]

Research Secretariat
Level 2
Samuel Way Building
72 King William Road
Adelaide 5000
South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/09/2016

Approval date [1]

19/10/2016

Ethics approval number [1]

HREC/16/WCHN/136

Summary

Brief summary

Study objectives: 1.To investigate children and families perspective on their experience when a family member has a brain injury 2.To understand if children perceive their needs were met as a significant other in the journey of a person with a brain injury. 3. To gain information on children and families perceptions of the optimum support system that should be offered including what, how, when and where.
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. The second phase of the research (not included in this stage of the trial– another application/grant will be sought) is expected to thereafter develop an age-appropriate children’s brain injury education program or ‘tool’ which will encapsulate the topics reported through the qualitative interview. 
The purpose of this research is to address the gaps in resources and tools that professionals can use when supporting and educating children after a parent or significant person in their lives has a brain injury. Children can be a ‘forgotten’ component in someone’s rehabilitation as practitioners are often unsure of how to age-appropriately educate them as there are minimal resources available. This research will compile the information direct from consumers as to how brain injury in the family has affected them, how their lives have changed, how they feel, how they coped, how their relationships have been affected and what would have helped them understand brain injury better through their loved ones recovery/rehabilitation. 
With this information, not only will consumers have felt heard, they would have contributed essential information that will form the basis of the second phase of research which will be developing an education program or ‘tool’ that can be used in any sub-acute brain injury rehabilitation setting across the world.
To ensure rigour of this research, 
1. Interviews will be audiotaped and transcribed.
2. It will be important to ensure truth value, credibility and dependability by taking care that all descriptions reported are accurate. Each participant will be provided with a summary of their interview summary to check before coding begins (Krefting 1991). 
3. Any discrepancies following member checking by participants will be altered ready for analysis. 
4. Field notes consisting of observations during the audiotaped interviews need to be developed (Patton 1990). 
The three researchers will meet regularly to undertake coding (open, followed by axial, followed by selective) until all agree that all possible hypotheses have been considered and consensus has been reached.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Maggie Killington

Address

South Australia Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085

Country

Australia

Phone

+61 400061204

Fax

[email protected]

Contact person for public queries

Name

Maggie Killington

Address

South Australia Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085

Country

Australia

Phone

+ 61 400061204

Fax

[email protected]

Contact person for scientific queries

Name

Maggie Killington

Address

South Australia Brain Injury Rehabilitation Services
Hampstead Rehabilitation Centre
Central Adelaide Local Health Network
207-255 Hampstead Road
Lightsview SA 5085

Country

Australia

Phone

+61 400061204

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Life altering effects on children when a family member has an acquired brain injury; a qualitative exploration of child and family perceptions.	2022	https://dx.doi.org/10.1080/09638288.2020.1766582

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically