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Trial registered on ANZCTR


Registration number
ACTRN12612000371897
Ethics application status
Approved
Date submitted
28/03/2012
Date registered
30/03/2012
Date last updated
16/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Family Intervention Following Paediatric Acquired Brain Injury
Scientific title
A sequential, comparison group pilot study to compare the effect of family therapy based interventions to "usual care" social work services on adaptation and wellbeing in families who have a child with an acquired brain injury.
Secondary ID [1] 280238 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family adaptation following the onset of a child's acquired brain injury. 286189 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286385 286385 0 0
Other physical medicine / rehabilitation
Mental Health 286386 286386 0 0
Other mental health disorders
Neurological 286405 286405 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Intervention Group (n=25) will receive the Family Intervention Clinical Protocol. The protocol will be delivered by a Social Worker of the Victorian Paediatric Rehabilitation Service (VPRS) at The Royal Children's Hospital (RCH).

The protocol will provide a range of specialist ABI psycho-social social work services informed by family therapy frameworks. The interventions will be individually tailored to meet the low, medium and high support needs of families.

The Family Intervention Clinical Protocol psychosocial interventions will include:
1. Counselling
2. Family Education relating to Paediatric ABI
3. Family Support Group

The Intervention Group will have a “universal” referral to the VPRS Social Worker administering the protocol. The Intervention Group will attend one-hour sessions, twice a week, for each week during the child’s inpatient rehabilitation stay. The Intervention Group will also attend an inpatient group sessions that will run for 45 minutes duration, once a week.
Intervention code [1] 284579 0
Treatment: Other
Intervention code [2] 284580 0
Rehabilitation
Comparator / control treatment
The Comparison Group (n=25) will receive “usual care” social work services consistent with social work practice provided to families of children who are patients at The Royal Children’s Hospital.

The Comparison Group will only be referred to social work if requested by the family or rehabilitation team regarding an identified need. The session length and frequency will be negotiated between the social worker and families.
Control group
Active

Outcomes
Primary outcome [1] 286843 0
Families who receive the Family Intervention will have greater capacity to adapt family functioning to meet the needs of all family members post injury compared with families who receive "usual care" social work services.
This outcome will be assessed using the Family Management Measure and Parent Experience of Childhood Illness
Timepoint [1] 286843 0
Six Weeks post Inpatient Discharge.
Primary outcome [2] 286844 0
Families who receive the Family Intervention will have better parent/carer and sibling adjustment and carer wellbeing to the child's ABI compared with families who receive "usual care" social work services.
This outcome will be assessed using SF36v2 and sibling questionnaire designed for the study.
Timepoint [2] 286844 0
Six Weeks post Inpatient Discharge.
Primary outcome [3] 286845 0
Families who receive the Family Intervention will have better parent/carer and sibling understanding of the child's ABI compared with families who receive "usual care" social work services.
This outcome will be assessed using the Brief Illness Perception Questionnair"
Timepoint [3] 286845 0
Six Weeks post Inpatient Discharge.
Secondary outcome [1] 296801 0
Families who receive the Family Intervention will have less parent/carer burden of care and post-trauma symptoms compared
with families who receive "usual care" social work services.
This outcome will be assessed using the Impact of Event Scale - Revised.
Timepoint [1] 296801 0
Six Weeks post Inpatient Discharge.
Secondary outcome [2] 296802 0
Families who receive the Family Intervention will have less parent/ carer grief and loss maladjustment compared with families who receive "usual care" social work services.
This outcome will be assessed using the Prolonged Grief Disorder - PG12.
Timepoint [2] 296802 0
Six Weeks post Inpatient Discharge.
Secondary outcome [3] 296803 0
Families who receive the Family Intervention will have greater satisfaction with the social work rehabilitation service compared with families who receive "usual care" social work services.
This outcome will be assessed using a social work service feedback questionnaire designed for the study
Timepoint [3] 296803 0
Six Weeks post Inpatient Discharge.

Eligibility
Key inclusion criteria
1. Families of children aged 0-18 years who have sustained an ABI and admitted to inpatient rehabilitation following the initial onset of injury. The paediatric rehabilitation admission is projected to be a minimum of two weeks.
2. Families of children with a co-morbidity other than a pre-existing acquired brain injury.
Minimum age
8 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Families of children with a non-accidental ABI will not be included in this study, due to the complexity of the social circumstances surrounding the injury and likelihood of complex pre-existing psycho-social issues.
2. Families of children who already have a pre-existing acquired brain injury.
3.Families of children who are already patients of the VPRS and are re-admitted as inpatients for a block of therapy will not be included in the study.
4. Families of children who have an expected length of stay in the VPRS inpatient service for less than two weeks.
5.Families of children with ABI who are the patient of VPRS inpatient rehabilitation services.
6.Siblings of children with ABI who are aged between 0-7 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Sequential comparison group design.

The Comparison Group participants will receive usual care (n=25) followed by the Intervention group participants receiving the Family Intervention (n = 25).
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285001 0
University
Name [1] 285001 0
Anita Morawetz Scholarship, University of Melbourne
Address [1] 285001 0
Faculty of Medicine, Dentistry and Health Sciences
University of Melbourne
Melbourne Vic 3010
Country [1] 285001 0
Australia
Primary sponsor type
Hospital
Name
The Royal Children's Hospital
Address
50 Flemington Road
Parkville Vic 3052
Country
Australia
Secondary sponsor category [1] 283865 0
University
Name [1] 283865 0
Department of Paediatrics, University of Melbourne
Address [1] 283865 0
University of Melbourne
Melbourne Vic 3010
Country [1] 283865 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287010 0
The Royal Children's Hospital Human Research and Ethics Committee
Ethics committee address [1] 287010 0
The Royal Children's Hospital
50 Flemington Road
Parkville Vic 3052
Ethics committee country [1] 287010 0
Australia
Date submitted for ethics approval [1] 287010 0
Approval date [1] 287010 0
16/03/2012
Ethics approval number [1] 287010 0
31212A

Summary
Brief summary
Aim:
1.To develop, implement and evaluate family interventions for supporting families of children with ABI in paediatric inpatient rehabilitation.
2.To compare outcomes of families who receive the family intervention to families who receive the “usual care” social work service during their child’s inpatient rehabilitation.
Study Design: A sequential comparison group design.
Procedure: Eligible participants will be invited to participate in the study at the time of their child’s admission to rehabilitation. During the child’s admission families will be recruited into the Comparison Group or Intervention Group and will receive “usual care” social work service or family intervention respectively.
Participants will complete questionnaires at admission (T1), discharge (T2) and 6 weeks post discharge (T3).
Data Analysis: The study will compare outcomes of the Intervention Group and Comparison Group at six weeks post discharge.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33995 0
Ms Lyndal Hickey
Address 33995 0
The Royal Children's Hospital
50 Flemington Road
Parkville Vic 3052
Country 33995 0
Australia
Phone 33995 0
61 3 93455081
Fax 33995 0
Email 33995 0
lyndal.hickey@rch.org.au
Contact person for public queries
Name 17242 0
A/Prof Associate Professor Brigid Jordan
Address 17242 0
Department of Paediatrics
University of Melbourne
50 Flemington Road
Parkille Vic 3052
Country 17242 0
Australia
Phone 17242 0
61 393454144
Fax 17242 0
Email 17242 0
brigid.jordan@rch.org.au
Contact person for scientific queries
Name 8170 0
A/Prof Associate Professor Brigid Jordan
Address 8170 0
Department of Paediatrics
University of Melbourne
50 Flemington Road
Parkville Vic 3052
Country 8170 0
Australia
Phone 8170 0
61 393454144
Fax 8170 0
Email 8170 0
brigid.jordan@rch.org.au

No information has been provided regarding IPD availability
Summary results
No Results