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Trial registered on ANZCTR


Registration number
ACTRN12611000003976
Ethics application status
Approved
Date submitted
30/11/2010
Date registered
4/01/2011
Date last updated
18/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Stepping Stones Cerebral Palsy Study: Optimising outcomes for children with Cerebral Palsy through a randomised controlled trial of a parenting intervention
Scientific title
The efficacy of Stepping Stones Triple P and a parental stress management intervention for child behavioural outcomes and parent adjustment in parents of children with Cerebral Palsy: a randomised controlled trial
Secondary ID [1] 253207 0
Nil
Universal Trial Number (UTN)
U1111-1118-3330
Trial acronym
Stepping Stones CP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 258739 0
Condition category
Condition code
Neurological 258890 258890 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two intervention conditions in this study.

Participants in both intervention conditions will receive the behavioural family intervention Stepping Stones Triple P. This involves teaching parents how to manage behavioural difficulties, how to teach children new skills and behaviours, how to use assertive discipline and how to optimise their child's development. This will be conducted as a group program with 6 groups sessions of 2 hours duration and an additional 3 telelphone consultations of 30 minutes duration.

One of the two intervention groups will also receive a parental stress management intervention based on Acceptance and Commitment Therapy (ACT). This intervention will target the following ACT processes: acceptance, cognitive defusion, mindfulness, values and committed action. The parental stress management intervention will consistent of 2 additional group sessions of 2 hours duration.
Intervention code [1] 257684 0
Behaviour
Comparator / control treatment
The control group is a wait list control group. The control group will receive the behavioural family intervention Stepping Stones Triple P once both intervention groups have completed their interventions and post-assessment is complete.
Control group
Active

Outcomes
Primary outcome [1] 259747 0
Child behaviour as measured by the Eyberg Child Behaviour Inventory (ECBI) and the Strengths and Difficulties Questionnaire (SDQ)
Timepoint [1] 259747 0
Pre-intervention, post-intervention, 6-month follow up
Primary outcome [2] 288006 0
Parenting Style as measured by the Parenting Scale
Timepoint [2] 288006 0
Pre-intervention, post-intervention, 6-month follow up
Secondary outcome [1] 268511 0
Functional performance as measured by the PEDI
Timepoint [1] 268511 0
Pre-intervention, post-intervention, 6-month follow up
Secondary outcome [2] 268512 0
Parent-reported child quality of life as measured by the CP QOL-Child
Timepoint [2] 268512 0
Pre-intervention, post-intervention, 6-month follow up
Secondary outcome [3] 299253 0
Dysfunctional parenting styles as measured by the Parenting Scale
Timepoint [3] 299253 0
Pre-intervention, post-intervention, 6-month follow up
Secondary outcome [4] 299254 0
Parental confidence in performing disability related parenting practices as measured by the Cerebral Palsy Daily Parenting Tasks Checklist
Timepoint [4] 299254 0
Pre-intervention, post-intervention, 6-month follow up
Secondary outcome [5] 299255 0
Degree of problems in performing disability related parenting practices as measured by the Cerebral Palsy Daily Parenting Tasks Checklist
Timepoint [5] 299255 0
Pre-intervention, post-intervention, 6-month follow up
Secondary outcome [6] 299256 0
Parental adjustment as measured by the DASS
Timepoint [6] 299256 0
Pre-intervention, post-intervention, 6-month follow up
Secondary outcome [7] 299257 0
Psychological flexibility as measured by the AAQ Child Disability version
Timepoint [7] 299257 0
Pre-intervention, post-intervention, 6-month follow up
Secondary outcome [8] 299258 0
Parental attitude to child emotions as measured by the PBANE
Timepoint [8] 299258 0
Pre-intervention, post-intervention, 6-month follow up

Eligibility
Key inclusion criteria
Participants must be the parent (including step or guardian) of a child (2-12 years of age) with a diagnosis of Cerebral Palsy (all motor functioning levels). In addition, parents must self-identify with a reason for participating in a parenting intervention. This may include concerns about behavioural problems or a desire to optimise their child's development.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents do not have a self-identified reason for participation in a parenting intervention.

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 will be gained from parents prior to allocation. Allocation will be conducted via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be completed via block randomisation using computerised sequence generation. Block randomisation will be used to ensure equal (or near equal) allocation of participants to groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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)
Recruitment postcode(s) [1] 3493 0
4029

Funding & Sponsors
Funding source category [1] 258155 0
Government body
Name [1] 258155 0
National Health and Medical Research Council
Address [1] 258155 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 258155 0
Australia
Funding source category [2] 258156 0
University
Name [2] 258156 0
The University of Queensland
Address [2] 258156 0
The University of Queensland
St Lucia
Brisbane 4072
Country [2] 258156 0
Australia
Primary sponsor type
Individual
Name
Koa Whittingham
Address
Queensland Cerebral Palsy and Rehabilitation Research Centre, Level 7, Block 6, RBWH Cnr Butterfield St and Bowen Bridge Rd Herston , Brisbane Australia 4029
Country
Australia
Secondary sponsor category [1] 257330 0
Individual
Name [1] 257330 0
A/Prof Roslyn Boyd
Address [1] 257330 0
Queensland Cerebral Palsy and Rehabilitation Research Centre, Level 7, Block 6, RBWH Herston, Brisbane Australia 4029
Country [1] 257330 0
Australia
Other collaborator category [1] 251702 0
Individual
Name [1] 251702 0
Prof Matthew Sanders
Address [1] 251702 0
Parenting and Family Support Centre,
The University of Queensland
St Lucia 4072
Country [1] 251702 0
Australia
Other collaborator category [2] 251703 0
Individual
Name [2] 251703 0
Dr Lynne McKinlay
Address [2] 251703 0
Director of Medicine
Level 1, North Tower
Royal Children's Hospital
Herston Rd, Herston QLD 4029
Country [2] 251703 0
Australia
Other collaborator category [3] 251704 0
Individual
Name [3] 251704 0
Dr Kate Sofronoff
Address [3] 251704 0
School of Psychology
The University of Queensland
St Lucia, QLD 4072
Country [3] 251704 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260138 0
Royal Children's Hospital and Health Services District Ethics Committee
Ethics committee address [1] 260138 0
Department of Paediatrics and Child Health
Level 3, Foundation Building
Royal Children's Hopsital
Herston Road, Herston QLD 4029
Ethics committee country [1] 260138 0
Australia
Date submitted for ethics approval [1] 260138 0
Approval date [1] 260138 0
08/12/2009
Ethics approval number [1] 260138 0
HREC/09/QRCH/125
Ethics committee name [2] 260139 0
The University of Queensland Behavioural and Social Sciences Research Ethics Comittee
Ethics committee address [2] 260139 0
Research and Innovation Division
The University of Queensland
St Lucia, QLD 4072
Ethics committee country [2] 260139 0
Australia
Date submitted for ethics approval [2] 260139 0
Approval date [2] 260139 0
12/01/2010
Ethics approval number [2] 260139 0
2009001871

Summary
Brief summary
It is well understood that parenting a child with a disability, such as CP, brings additional challenges e.g. increased burden of care and grief. Mothers of children with CP experience greater parental stress and anxious/depressive symptoms. In addition, children with CP are more likely to face behavioural and emotional problems which is in turn associated with further increases in parental stress. Parental stress and child behavioural problems are likely to impact on the optimising of physical, behavioural and educational outcomes in children with CP over and above the impact of the initial brain lesion on disability.

Behavioural Family Interventions aim to improve child behaviour and adjustment through changes in the family environment and are well established for improving child behavioural outcomes in typically developing children. The behavioural family intervention Triple P (Positive Parenting Program) has been developed and evaluated extensively over the past 30 years and is implemented in Australia and 19 other countries. The results of three independent meta-analyses using 55 evaluation studies confirm that Triple P has significant positive effects on child behaviour and parenting style. The effect size of Triple P with high-risk groups such as parents of children with ADHD is large (mean d = 0.88). Stepping Stones Triple P (SSTP) is a new variant of Triple P that targets families of children with disabilities. SSTP has a meaningful treatment effect with families of children with developmental disabilities and is efficacious for families of children with Autism Spectrum Disorder (ASD). SSTP has not yet been validated specifically with parents of children with CP.

In addition, we will specifically target parenting stress with a parental stress intervention based on Acceptance and Commitment Therapy. ACT is a new cognitive behavioural intervention model that incorporates mindfulness (psychological contact with the present moment) and acceptance (of emotional and cognitive responses). The goal is to increase psychological flexibility- the ability to persist or change in the service of chosen values. ACT has the ability to contribute to parenting interventions by addressing the emotional context of parenting including increasing the parent’s ability to foster their child’s emotional regulation skills and to improve the parent child relationship. Mindfulness and acceptance have been found to decrease distress in parents of children with disabilities however, research has yet to focus on the additive benefit of ACT to Behavioural Family Interventions.

This study aims to assess the efficacy of the Behavioural Family Intervention Stepping Stones Triple P with families of children with Cerebral Palsy. In addition, we aim to test the additive effects of an ACT-based parental stress management intervention. It is predicted that Stepping Stones Triple P will be associated with reductions in child behavioural problems. It is predicted that the addition of an ACT-based parental stress management intervention will lead to additive effects on parental adjustment.
Trial website
http://www2.som.uq.edu.au/som/Research/ResearchCentres/qcprrc/projects/Pages/TripleP-TheSteppingStonesCPProject.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31969 0
Address 31969 0
Country 31969 0
Phone 31969 0
Fax 31969 0
Email 31969 0
Contact person for public queries
Name 15216 0
Dr Koa Whittingham
Address 15216 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
UQ Dept of Paediatrics and Child Health
Level 3, Foundation Building
Royal Children's Hospital
Herston Road, Herston QLD 4029
Country 15216 0
Australia
Phone 15216 0
+61 7 3636 5539
Fax 15216 0
Email 15216 0
koawhittingham@uq.edu.au
Contact person for scientific queries
Name 6144 0
Dr Koa Whittingham
Address 6144 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
UQ Dept of Paediatrics and Child Health
Level 3, Foundation Building
Royal Children's Hospital
Herston Road, Herston QLD 4029
Country 6144 0
Australia
Phone 6144 0
+61 7 3636 5539
Fax 6144 0
Email 6144 0
koawhittingham@uq.edu.au

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