Trial Review

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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
Sex
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
6/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
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
Country [1] 258155 0
Australia
Funding source category [2] 258156 0
University
Name [2] 258156 0
The University of Queensland
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
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
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
Trial website
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


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
No additional documents have been identified.