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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]

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

Condition category

Condition code

Neurological

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]

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]

Child behaviour as measured by the Eyberg Child Behaviour Inventory (ECBI) and the Strengths and Difficulties Questionnaire (SDQ)

Timepoint [1]

Pre-intervention, post-intervention, 6-month follow up

Primary outcome [2]

Parenting Style as measured by the Parenting Scale

Timepoint [2]

Pre-intervention, post-intervention, 6-month follow up

Secondary outcome [1]

Functional performance as measured by the PEDI

Timepoint [1]

Pre-intervention, post-intervention, 6-month follow up

Secondary outcome [2]

Parent-reported child quality of life as measured by the CP QOL-Child

Timepoint [2]

Pre-intervention, post-intervention, 6-month follow up

Secondary outcome [3]

Dysfunctional parenting styles as measured by the Parenting Scale

Timepoint [3]

Pre-intervention, post-intervention, 6-month follow up

Secondary outcome [4]

Parental confidence in performing disability related parenting practices as measured by the Cerebral Palsy Daily Parenting Tasks Checklist

Timepoint [4]

Pre-intervention, post-intervention, 6-month follow up

Secondary outcome [5]

Degree of problems in performing disability related parenting practices as measured by the Cerebral Palsy Daily Parenting Tasks Checklist

Timepoint [5]

Pre-intervention, post-intervention, 6-month follow up

Secondary outcome [6]

Parental adjustment as measured by the DASS

Timepoint [6]

Pre-intervention, post-intervention, 6-month follow up

Secondary outcome [7]

Psychological flexibility as measured by the AAQ Child Disability version

Timepoint [7]

Pre-intervention, post-intervention, 6-month follow up

Secondary outcome [8]

Parental attitude to child emotions as measured by the PBANE

Timepoint [8]

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]

4029

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

University

Name [2]

The University of Queensland

Address [2]

The University of Queensland
St Lucia
Brisbane 4072

Country [2]

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]

Individual

Name [1]

A/Prof Roslyn Boyd

Address [1]

Queensland Cerebral Palsy and Rehabilitation Research Centre, Level 7, Block 6, RBWH Herston, Brisbane Australia 4029

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Prof Matthew Sanders

Address [1]

Parenting and Family Support Centre,
The University of Queensland
St Lucia 4072

Country [1]

Australia

Other collaborator category [2]

Individual

Name [2]

Dr Lynne McKinlay

Address [2]

Director of Medicine
Level 1, North Tower
Royal Children's Hospital
Herston Rd, Herston QLD 4029

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Kate Sofronoff

Address [3]

School of Psychology
The University of Queensland
St Lucia, QLD 4072

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Children's Hospital and Health Services District Ethics Committee

Ethics committee address [1]

Department of Paediatrics and Child Health
Level 3, Foundation Building
Royal Children's Hopsital
Herston Road, Herston QLD 4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

08/12/2009

Ethics approval number [1]

HREC/09/QRCH/125

Ethics committee name [2]

The University of Queensland Behavioural and Social Sciences Research Ethics Comittee

Ethics committee address [2]

Research and Innovation Division
The University of Queensland
St Lucia, QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

12/01/2010

Ethics approval number [2]

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

Address

Country

Phone

Fax

Email

Contact person for public queries

Name

Dr Koa Whittingham

Address

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

Australia

Phone

+61 7 3636 5539

Fax

Email

[email protected]

Contact person for scientific queries

Name

Dr Koa Whittingham

Address

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

Australia

Phone

+61 7 3636 5539

Fax

Email

[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.