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Trial registered on ANZCTR


Registration number
ACTRN12610001051033
Ethics application status
Approved
Date submitted
24/11/2010
Date registered
30/11/2010
Date last updated
21/05/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stepping Stones Triple P for Parents of Children with Acquired Brain Injury
Scientific title
Efficacy of a behavioural family intervention plus a stress management adjunct on parental adjustment and child behavioural and emotional outcomes in parents of children with acquired brain injury: A randomised controlled trial
Secondary ID [1] 253014 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 258564 0
Condition category
Condition code
Injuries and Accidents 258705 258705 0 0
Other injuries and accidents
Neurological 258706 258706 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There will be one treatment group in this study. Participants will receive a behavioural family intervention which aims to teach parents ways to manage children's behavioural and emotional difficulties, and to teach them new skills, while at the same time aiming to improve parents' confidence and parenting skills, and reduce stress. This program will be conducted as a group program with 5-10 families per group. 6 group sessions running for 2 hours each will be offered, with an additional 3 or 4 telephone consults each running for approximately 30 minutes. Participants will also receive an adjunct intervention targetting parental stress and coping prior to receiving the behavioural family intervention. This program will consist of 2 group sessions running for 2 hours each, and will be based in Acceptance and Commitment Therapy (ACT). The goal of ACT is to increase psychological flexibility, or the ability to persist or change in the service of chosen life values. The group program will address the following ACT processes: acceptance of negative cognitions and emotions, cognitive defusion, mindfulness or present moment awareness, values, and committed action. The total length of the intervention will be 10 weeks. All programs will be conducted by registered provisionally registered psychologists from the University of Queensland.
Intervention code [1] 257536 0
Rehabilitation
Intervention code [2] 257537 0
Behaviour
Comparator / control treatment
The treatment group will be compared to a wait-list control group, who will receive the behavioural family intervention once both treatment groups have completed their interventions. The treatment groups will also be compared to one another, to determine whether the ACT adjunct provides additional therapeutic benefit.
Control group
Active

Outcomes
Primary outcome [1] 259570 0
Child behavioural outcome, as measured by the Eyberg Child Behaviour Inventory (ECBI)
Timepoint [1] 259570 0
Pre-intervention, Post-intervention, 6-month follow-up
Primary outcome [2] 289631 0
Dysfunctional parenting style, as measured by the Parenting Scale
Timepoint [2] 289631 0
Pre-intervention, Post-intervention, 6-month follow-up
Secondary outcome [1] 266189 0
Child behavioural and emotional outcomes, as measured by the Strengths and Difficulties Questionnaire (SDQ)
Timepoint [1] 266189 0
Pre-intervention, Post-intervention, 6-month follow-up
Secondary outcome [2] 266190 0
Parental adjustment (stress, anxiety and depression symptoms), as measured by the Depression Anxiety and Stress Scale (DASS)
Timepoint [2] 266190 0
Pre-intervention, Post-intervention, 6-month follow-up
Secondary outcome [3] 302892 0
Parenting confidence as measured by the Parenting Tasks Checklist
Timepoint [3] 302892 0
Pre-intervention, Post-intervention, 6-month follow-up
Secondary outcome [4] 302893 0
Parent psychological flexibility, as measured by an adapted Acceptance and Action Questionnaire specific for the ABI population, as well as the Parent Thoughts and Feelings Questionnaire.
Timepoint [4] 302893 0
Pre-intervention, post-intervention, 6-month follow-up
Secondary outcome [5] 302894 0
Family functioning, as assessed by the General Functioning scale of the Family Assessment Device (FAD).
Timepoint [5] 302894 0
Pre-intervention, post-intervention, 6-month follow-up
Secondary outcome [6] 302895 0
Parent relationship functioning, as assessed by the Relationship Quality Index (RQI), and the Parent Problem Checklists (PPC).
Timepoint [6] 302895 0
Pre-intervention, post-intervention, 6-month follow-up

Eligibility
Key inclusion criteria
Parents will be able to participate in the study if they meet the following criteria: -their child is aged between 2 and 12 -their child has a diagnosis of an acquired brain injury -the injury occured at least 3 months prior to commencement of the intervention - the child is no longer acutely unwell -their child is displaying some behavioural, emotional, or developmental difficulties (based on parent self-report). - Parents speak adequate English to participate in the group program. Grandparents who are the primary carers for children meeting the above criteria will also be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- child is participating in a concurrent research project targetting child behavioural or emotional difficulties (eg. anger management)
- child is not experiencing any ongoing behavioural, emotional, or developmental difficulties following the brain injury
-child is in the custody of the Department of Child Safety

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be assessed for eligibility and enrolled in the study as they volunteer. Informed consent for participation will be gained from parents.

Prior to the intervention, participants will be asked to complete their baseline questionnaire packs. Once this is received back from a participant, they will be randomly assigned to a group and informed of their allocation and the dates and times of their group. The random allocation will be from sealed opaque envelopes.

Treatment allocation will be recorded on a piece of paper, folded and placed inside each envelope in a random, computer generated, order. Envelopes will be opened in order as each participant is to be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation will be employed.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This study has a treatment groups and a waitlist control group. The wait-list control group will also receive the comprehensive behavioural family intervention once the treatment groups have concluded their intervention.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
Recruitment postcode(s) [1] 3404 0
4029
Recruitment postcode(s) [2] 3405 0
4072

Funding & Sponsors
Funding source category [1] 257986 0
Self funded/Unfunded
Name [1] 257986 0
University of Queensland
Address [1] 257986 0
PhD student funds for primary investigator:
Felicity Brown
School of Psychology
University of Queensland
St Lucia, QLD 4072
Country [1] 257986 0
Australia
Funding source category [2] 257987 0
Charities/Societies/Foundations
Name [2] 257987 0
Queensland Children's Medical Research Institute
Address [2] 257987 0
Scholarship support

Level 4, Foundation Building
Royal Children's Hospital
Herston Rd, Herston, QLD 4029
Country [2] 257987 0
Australia
Funding source category [3] 257988 0
Other Collaborative groups
Name [3] 257988 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
Address [3] 257988 0
In-kind support such as providing a computer, desk, telephone, printing, and other minor costs.

Level 3, Foundation Building
Royal Children's Hospital
Herston Rd, Herston, QLD 4029
Country [3] 257988 0
Australia
Primary sponsor type
Individual
Name
Assoc Prof Kate Sofronoff
Address
School of Psychology
University of Queensland
St Lucia
QLD 4072
Country
Australia
Secondary sponsor category [1] 257186 0
None
Name [1] 257186 0
Address [1] 257186 0
Country [1] 257186 0
Other collaborator category [1] 251635 0
Individual
Name [1] 251635 0
Dr Kate Sofronoff
Address [1] 251635 0
(Primary supervisor of Felicity Brown)
School of Psychology
University of Queensland
St Lucia, QLD 4072
Country [1] 251635 0
Australia
Other collaborator category [2] 251636 0
Individual
Name [2] 251636 0
Dr Koa Whittingham
Address [2] 251636 0
(Associate supervisor of Felicity Brown)
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 3, Foundation Building
Royal Children's Hospital
Herston Rd, Herston, QLD 4029
Country [2] 251636 0
Australia
Other collaborator category [3] 251637 0
Individual
Name [3] 251637 0
Assoc Prof Roslyn Boyd
Address [3] 251637 0
(Associate supervisor of Felicity Brown)
Queensland Cerebral Palsy and Rehabilitation Research Centre
Level 3, Foundation Building
Royal Children's Hospital
Herston Rd, Herston, QLD 4029
Country [3] 251637 0
Australia
Other collaborator category [4] 251638 0
Individual
Name [4] 251638 0
Dr Lynne McKinlay
Address [4] 251638 0
(Associate supervisor of Felicity Brown)
Director of Medicine
Level 1, North Tower
Royal Children's Hospital
Herston Rd, Herston, QLD 4029
Country [4] 251638 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259983 0
Royal Children's Hospital and Health Services District Ethics Committee
Ethics committee address [1] 259983 0
Department of Paediatrics and Child Health
Level 3, Foundation Building
Royal Children's Hospital
Herston Road, Herston QLD 4029
Ethics committee country [1] 259983 0
Australia
Date submitted for ethics approval [1] 259983 0
15/07/2010
Approval date [1] 259983 0
03/08/2010
Ethics approval number [1] 259983 0
HREC/10/QRCH/67
Ethics committee name [2] 259984 0
The University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 259984 0
Research and Innovation Division
University of Queensland
St Lucia, QLD 4072
Ethics committee country [2] 259984 0
Australia
Date submitted for ethics approval [2] 259984 0
10/08/2010
Approval date [2] 259984 0
18/08/2010
Ethics approval number [2] 259984 0
2010001056
Ethics committee name [3] 289295 0
Mater Medical Research Institute
Ethics committee address [3] 289295 0
Mater Hospital, Raymond Tce, South Brisbane, QLD 4101
Ethics committee country [3] 289295 0
Australia
Date submitted for ethics approval [3] 289295 0
Approval date [3] 289295 0
18/07/2011
Ethics approval number [3] 289295 0
1731C
Ethics committee name [4] 289296 0
Education Queensland
Ethics committee address [4] 289296 0
Education House
30 Mary St, Brisbane, QLD 4000
Ethics committee country [4] 289296 0
Australia
Date submitted for ethics approval [4] 289296 0
Approval date [4] 289296 0
28/02/2011
Ethics approval number [4] 289296 0
550/27/1046
Ethics committee name [5] 289297 0
Catholic Education QLD
Ethics committee address [5] 289297 0
PO Box 1201
Brisbane QLD 4001
Ethics committee country [5] 289297 0
Australia
Date submitted for ethics approval [5] 289297 0
10/03/2011
Approval date [5] 289297 0
Ethics approval number [5] 289297 0
2011/146

Summary
Brief summary
An acquired brain injury (or ABI) refers to an injury to the brain that has occurred after birth. Common causes of traumatic brain injury (the most common subtype of ABI) are motor vehicle accidents, falls, sporting injuries, or assaults. Other causes of brain injury include stroke, tumor, infection, or hypoxia. In children, brain injury can cause existing skills and abilities to be lost at least temporarily, and can also cause delays in the development of new skills. Some children recover very well, however it is quite common for children to experience some form of behavioural, social, academic, physical, emotional or developmental problems. It is recognised that acquired brain injury can impact on the entire family system. Not only do parents have to manage the stress associated with the difficulties that their child is experiencing, they are also often dealing with many emotions related to the ABI, attending many appointments for their child, and dealing with schools and various other agencies. This study aims to assess the efficacy of a behavioural family intervention, plus an ACT-based intervention addressing the emotional costs of ABI, tailored specifically for parents of children with ABI, with an emphasis on the difficulties that might be unique to these families. It is predicted that this intervention will lead to decreases in child problem behaviour and emotional difficulties, improvements in parenting style, and improvements in parental adjustment.
Trial website
http://exp.psy.uq.edu.au/steppingstonesbraininjury
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31865 0
Ms Felicity Brown
Address 31865 0
School of Psychology
University of QLD
St Lucia, QLD 4072
Country 31865 0
Australia
Phone 31865 0
+61 407 151 650
Fax 31865 0
Email 31865 0
f.brown@psy.uq.edu.au
Contact person for public queries
Name 15112 0
Ms Felicity Brown
Address 15112 0
School of Psychology
University of Queensland
St Lucia, QLD 4072
Country 15112 0
Australia
Phone 15112 0
+61 7 3346 7285 or +61 7 3636 1292
Fax 15112 0
+61 7 3636 5538
Email 15112 0
f.brown@psy.uq.edu.au
Contact person for scientific queries
Name 6040 0
Ms Felicity Brown
Address 6040 0
School of Psychology
University of Queensland
St Lucia, QLD 4072
Country 6040 0
Australia
Phone 6040 0
+61 7 3346 7285 or +61 7 3636 1292
Fax 6040 0
+61 7 3636 5538
Email 6040 0
f.brown@psy.uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary