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Trial registered on ANZCTR


Registration number
ACTRN12613000803796
Ethics application status
Approved
Date submitted
10/07/2013
Date registered
22/07/2013
Date last updated
5/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Stepping Stones Triple P Project: A population trial of a parenting program for parents with children with disabilities
Scientific title
An evaluation of a population-level roll out of the Stepping Stones Triple P - Positive Parenting Program across Queensland, Victoria and New South Wales, for parents and caregivers of children aged 2-12 years with a disability and the professionals who work with them, on levels of child behavioural and emotional problems, parenting behaviours and parent stress.
Secondary ID [1] 281949 0
Nil
Universal Trial Number (UTN)
U1111-1139-7848
Trial acronym
SSTP Project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental disability 288363 0
Intellectual disability 288364 0
Autism Spectrum Disorders (including autism, Autistic Disorder, Asperger's Disorder, PDD-NOS) 288365 0
Neurological, motor, or sensory disability 288366 0
Child behavioural and emotional problems 288367 0
Parenting practices and self-efficacy 289046 0
Condition category
Condition code
Mental Health 288711 288711 0 0
Other mental health disorders
Human Genetics and Inherited Disorders 288712 288712 0 0
Other human genetics and inherited disorders
Public Health 288713 288713 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Stepping Stones Triple P - Positive Parenting Program (SSTP) is a system of interventions for parents of children with a disability. SSTP is a form of behavioural family intervention. There are 5 different levels of SSTP, which vary with regards to delivery mode, intensity and breadth of intervention, and amount of practitioner contact. Parents are able to choose the level/s of the program most suited to their needs.

The five levels of SSTP are:

Level 1: Public health media campaign - a broad, multimedia, parent education campaign to raise awareness of the challenges of parenting a child with a disability and to encourage participation in parenting programs.

Level 2: SSTP Seminar Series - Three, 2-hour large group seminars providing information on positive parenting principles. Parents can choose to attend as many of the three seminars they feel are appropriate for their needs. Parents also had access to Seminars online.

Level 3: Primary Care SSTP - Brief individual program (4 x 15-30 minute sessions) with a trained practitioner providing strategies on managing specific, parent-identified challenging behaviours. Sessions are conducted weekly. The final session is delivered as needed.

Level 4: Group or Standard or Self-directed SSTP. All programs focus on broad parenting strategies related to a variety of challenging behaviours. Group SSTP is run with groups of parents over 6 x 2.5 hour sessions conducted weekly. Standard SSTP is an individual program offered over 10 x 1 hour sessions conducted weekly. Self-directed SSTP is a parent-completed work book with 10 weeks of parenting exercises or Triple P Online an 8 module practitioner-monitored program.

Level 5: Enhanced Triple P - Four individual modules with 3-10 individual sessions for parents who have previously completed a different SSTP level and would like extra support. The 1-hour modules parent rather than child focussed, and cover topics such as parent mental health or family conflict. Sessions are conducted weekly.

Practitioners delivering the SSTP programs will complete a session checklist to track treatment fidelity. This includes checking that parents have completed their homework. Practitioners will also track session attendance by parents and caregivers. This regular monitoring will be given to the research team and used to measure parent outcomes

Families in Queensland and Victoria will have access to levels 1-4 of SSTP. Families in New South Wales will have access to Levels 1, 2 and 3.
Intervention code [1] 286518 0
Treatment: Other
Intervention code [2] 286519 0
Behaviour
Intervention code [3] 286520 0
Prevention
Comparator / control treatment
The target population is parents and caregivers of children aged 2-12 years with a disability. A sub-sample consisting of parents/caregivers of children aged 2 to 10 years with an intellectual disability will be followed more closely.

There is no control treatment for professionals in the study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288868 0
Primary Outcome 1: Child emotional and behavioural problems.

This will be assessed with multiple measures: Total Behaviour Problem Score and subscale scores on the Developmental Behaviour Checklist - Parent (DBC-P) or Developmental Behaviour Checklist - Parent - Under 4 (DBC-U4) or the associated short forms; total scores on the Behavioural and Emotional Adjustment subscales of the Child Adjustment and Parent Efficacy Scale (CAPES-DD).
Timepoint [1] 288868 0
For the entire target population (including the sub-sample): Baseline and at 3 months and 15 months after baseline.
Secondary outcome [1] 302612 0
Secondary Outcome 2: Parenting practices and parent adjustment.

This will be assessed by total scores on the relevant subscales of the Parent and Family Adjustment Subscale (PAFAS)
Timepoint [1] 302612 0
For the entire target population (including the sub-sample): Baseline and at 3 months and 15 months after baseline.
Secondary outcome [2] 302613 0
Secondary Outcome 3: Parent efficacy.

This will be assessed by total scores on the Efficacy subscale of the Child Adjustment and Parent Efficacy Scale - Developmental Disability (CAPES-DD)
Timepoint [2] 302613 0
For the entire target population (including the sub-sample): Baseline and at 3 months and 15 months after baseline.
Secondary outcome [3] 302614 0
Secondary Outcome 4: Parenting conflict.

This will be assessed by total scores on the Parent Problem Checklist.
Timepoint [3] 302614 0
For the sub-sample only: Baseline and at 3 months and 15 months after baseline.
Secondary outcome [4] 302615 0
Secondary Outcome 5: Parent anxiety, depression and stress.

This will be assessed by scores on the Depression Anxiety Stress Scales (DASS-21).
Timepoint [4] 302615 0
For the sub-sample only: Baseline and at 3 months and 15 months after baseline.
Secondary outcome [5] 302616 0
Secondary Outcome 6: Parent participation and life satisfaction.

This will be assessed based on parent responses to descriptive questions about their participation in educational and employment opportunities as well as perceived life satisfaction. Questions are author-constructed or taken from the Longitudinal Study of Australian Children (LSAC).
Timepoint [5] 302616 0
For the entire target population (including the sub-sample): Baseline and at 3 months and 15 months after baseline.
Secondary outcome [6] 302617 0
Secondary Outcome 7: Parent satisfaction with program delivery.

This will be assessed by responses on the Client Satisfaction Questionnaire (CSQ)
Timepoint [6] 302617 0
After receiving an SSTP intervention. For all groups, this measure will be collected 3 months after commencing a SSTP intervention program.
Secondary outcome [7] 302619 0
Secondary Outcome 8: Professional parent consultation skills and program implementation fidelity.

This will be assessed with responses on multiple measures: Parent Consultation Skills Checklist, Practice Audit, SSTP Session Checklists.
Timepoint [7] 302619 0
Parent Consultation Skills Checklist was completed before and after training, and at accreditation.
Secondary outcome [8] 303511 0
Secondary Outcome 9: Time and financial costs of care.

This will be assessed based on parent responses to descriptive questions about their employment and financial and time costs of caring for their child with a disability.
Timepoint [8] 303511 0
For the sub-sample only: Baseline and at 3 months and 15 months after baseline.
Secondary outcome [9] 303512 0
Secondary Outcome 10: Quality of life.

This will be assessed by responses on the EQ-5D, which measures the parents' or caregivers' quality of life.
Timepoint [9] 303512 0
For the sub-sample only: Baseline and at 3 months and 15 months after baseline.
Secondary outcome [10] 347737 0
Child activity and participation rates. This will be assessed based on parent responses to descriptive questions about children's participation in school and social activities. Questions are author-constructed or taken from the Longitudinal Study of Australian Children (LSAC).
Timepoint [10] 347737 0
For the entire target population (including the sub-sample): Baseline and at 3 months and 15 months after baseline.

Eligibility
Key inclusion criteria
Total target population:

Parents and caregivers who meet the following criteria:
1. Have a child aged 2-12 years
2. Child has a disability (including intellectual impairment/intellectual disability; developmental disability; an autism spectrum disorder; language delay or disorder; motor, sensory, or physical disability)
3. Child’s diagnosis was made by a paediatrician, psychiatrist, psychologist, neurologist, speech pathologist, or occupational therapist
4. Parent lives in a state currently participating in the SSTP roll out
5. Parent has sufficient language skills to participate in a SSTP program and complete assessment measures, or can access language support

Professionals who meet the following criteria:
1. Work individually or as part of an organisation with children with a disability (including intellectual impairment/intellectual disability; developmental disability; an autism spectrum disorder; language delay or disorder; motor, sensory, or physical disability)
2. Work in a state currently participating in the SSTP roll out
3. Have the capacity to offer a pre-determined number of SSTP programs within their work role.

Sub-sample population:

Parents and caregivers who meet the following criteria:
1. Have a child aged 2-10 years
2. Child has an intellectual impairment/intellectual disability (if aged 6+ years) or developmental delay (if aged less than 6 years)
3. Child’s diagnosis is confirmed through provision of reports or standardised assessments to the research team
4. Parent lives in a state currently participating in the SSTP roll out
5. Parent has sufficient language skills to participate in a SSTP program and complete assessment measures, or can access language support.
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will only be excluded if they do not meet the inclusion criteria listed above.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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
Non-randomised trial study design
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Identify-linked longitudinal data will be available, relating to different levels of participation. Random effects regression will be used to model child and family level outcomes as a function of occasion of measurement to investigate whether time trajectories of variables of interest vary within and between participants.

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)
NSW,QLD,VIC

Funding & Sponsors
Funding source category [1] 287220 0
Government body
Name [1] 287220 0
National Health and Medical Research Council
Address [1] 287220 0
GPO Box 1421
Canberra ACT 2601
Country [1] 287220 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Professor Stewart Einfeld
94 Mallett St
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 285973 0
University
Name [1] 285973 0
The University of Queensland
Address [1] 285973 0
Professor Matthew Sanders
Parenting and Family Support Centre
School of Psychology
The University of Queensland
Brisbane
QLD 4072
Country [1] 285973 0
Australia
Secondary sponsor category [2] 285974 0
University
Name [2] 285974 0
Monash University
Address [2] 285974 0
Emeritus Professor Bruce Tonge
Centre for Developmental Psychiatry & Psychology
Early in Life Mental Health Service
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country [2] 285974 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289205 0
The University of Sydney Human Ethics Research Committee
Ethics committee address [1] 289205 0
Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006
Ethics committee country [1] 289205 0
Australia
Date submitted for ethics approval [1] 289205 0
19/03/2012
Approval date [1] 289205 0
09/05/2012
Ethics approval number [1] 289205 0
14710
Ethics committee name [2] 289206 0
The University of Queensland Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [2] 289206 0
The Office of Research and Postgraduate Studies
Cumbrae-Stewart Bldg (72)
THE UNIVERSITY OF QUEENSLAND
Brisbane
QLD 4072
Ethics committee country [2] 289206 0
Australia
Date submitted for ethics approval [2] 289206 0
10/09/2012
Approval date [2] 289206 0
20/09/2012
Ethics approval number [2] 289206 0
2012001065
Ethics committee name [3] 289207 0
Monash University Human Research Ethics Committee
Ethics committee address [3] 289207 0
Monash Research Office
Building 3d
Monash University
Victoria 3800
Ethics committee country [3] 289207 0
Australia
Date submitted for ethics approval [3] 289207 0
05/02/2013
Approval date [3] 289207 0
10/04/2013
Ethics approval number [3] 289207 0
CF13/312-2013000143

Summary
Brief summary
The Stepping Stones Project aims to address the significant, unmet mental health needs of young people with disabilities and their families. This project will raise awareness of the importance of early intervention for emotional and behavioural problems in young people with disabilities and improve access to the evidence-based positive parenting intervention, Stepping Stones Triple P. As part of the study, parents and caregivers of children with a disability aged 2-12 will be able to access free Stepping Stones Triple P parenting programs. Professionals will be able to access free training in Stepping Stones Triple P. Stepping Stones Triple P programs will gradually become available across Queensland, Victoria and New South Wales. It is expected that participating in Stepping Stones Triple P parenting programs will lead to individual and population-wide reductions in child behavioural and emotional difficulties and parent stress, and improve access to evidence-based parenting programs in the community.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37830 0
Prof Stewart L. Einfeld
Address 37830 0
Brain & Mind Research Institute
94 Mallett Street
Camperdown
NSW 2050
Country 37830 0
Australia
Phone 37830 0
+61 2 93510885
Fax 37830 0
Email 37830 0
stewart.einfeld@sydney.edu.au
Contact person for public queries
Name 37831 0
A/Prof Kylie Gray
Address 37831 0
Centre for Developmental Psychiatry and Psychology
Monash Medical Centre
246 Clayton Rd
Clayton, VIC 3168
Country 37831 0
Australia
Phone 37831 0
+61 3 9594 1300
Fax 37831 0
Email 37831 0
kylie.gray@monash.edu
Contact person for scientific queries
Name 37832 0
Prof Stewart L. Einfeld
Address 37832 0
Brain & Mind Research Institute
94 Mallett Street
Camperdown
NSW 2050
Country 37832 0
Australia
Phone 37832 0
+61 2 93510885
Fax 37832 0
Email 37832 0
stewart.einfeld@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1683 0
Mazzucchelli, T.G., Hodges, J., Kanea, R.T., Sofronoff, K., Sanders, M.R.,
Einfeld, S., Tonge, B., Gray, K.M., & MHYPEDD Project Team (2018). Parenting and Family Adjustment Scales (PAFAS): Validation of a brief parent-report measure for use with families who have a child with a developmental disability. Research in Developmental Disabilities, 72, 140-151.
Attachments [1] 1683 0
Publication date and citation/details [2] 1684 0
Teague, S.J., Newman, L.K., Tonge, B.J., Gray, K.M., and the MHYPeDD study group.
(2018). Caregiver mental health, parenting practices, and perceptions of child attachment in children with Autism Spectrum Disorder. Journal of Autism and Developmental Disorders, 48(8), 2642–2652.
Attachments [2] 1684 0
Publication date and citation/details [3] 1685 0
Bezzina, L.A., Rice, L.J., Howlin, P., Tonge, B.J., Einfeld, S.L., & the MHYPeDD project team. (2017). Syndrome specific modules to enhance the Stepping Stones Triple P public health intervention. Journal of Intellectual Disability Research, 61, 836–842.
Attachments [3] 1685 0
Publication date and citation/details [4] 1686 0
Arora, S., Goodall, S., Viney, R., Einfeld, S. (2018). Using discrete-choice experiment methods to estimate the value of informal care: The case of children with intellectual disability. PharmacoEconomics, 1-11.
Attachments [4] 1686 0
Publication date and citation/details [5] 1687 0
Aery, A., Hodges, J., & Day, J. (2018, July). The Effect of School-Based Stepping Stones Triple P on Child and Parent Outcomes. In Universitas Indonesia International Psychology Symposium for Undergraduate Research (UIPSUR 2017). Atlantis Press.
Attachments [5] 1687 0
Publication date and citation/details [6] 1693 0
Hinton, S., Sheffield, J., Sanders, M. R., & Sofronoff, K. (2017). A randomized controlled trial of a telehealth parenting intervention: A mixed-disability trial. Research in Developmental Disabilities, 65, 74-85.
Attachments [6] 1693 0
Publication date and citation/details [7] 1694 0
Emser, T. S., Mazzucchelli, T. G., Christiansen, H., & Sanders, M. R. (2016). Child Adjustment and Parent Efficacy Scale-Developmental Disability (CAPES-DD): First psychometric evaluation of a new child and parenting assessment tool for children with a developmental disability. Research in developmental disabilities, 53, 158-177.
Attachments [7] 1694 0
Publication date and citation/details [8] 1695 0
Tonge et al. (2017). Mental health and mental disability: the need for public mental health. Chinese Journal of Disability Research, Phase 2 (Issue 26), 33-38.
Attachments [8] 1695 0
Publication date and citation/details [9] 1696 0
Rice, L. J., Emerson, E., Gray, K. M., Howlin, P., Tonge, B. J., Warner, G. L., & Einfeld, S. L. (2018). Concurrence of the strengths and difficulties questionnaire and developmental behaviour checklist among children with an intellectual disability. Journal of Intellectual Disability Research, 62(2), 150-155.
Attachments [9] 1696 0
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 1688 0
Other
Citation/DOI/link/details [1] 1688 0
Book Chapter

Sofronoff, K., Gray, K., Einfeld, B., Tonge, B. (2018). Supporting families of children
with a disability. In M.R. Sanders & T.G. Mazzuchelli (Eds.). The power of positive parenting: Transforming the lives of children, parents, and communities using the Triple P system (pp. 442-456). New York: Oxford University Press.
Attachments [1] 1688 0
Citation type [2] 1689 0
Conference abstract
Citation/DOI/link/details [2] 1689 0
Gray, K.M., Hu, N., Tonge, B.J., Taffe, J.R., Sanders, M., Sofronoff, K., & Einfeld, S.L.
(2018). A community-based parenting intervention for parents of children with a disability: Comparison of effectiveness for children with and without Autism Spectrum Disorder. Journal of Intellectual Disability Research, 62(8), 667.
Attachments [2] 1689 0
Citation type [3] 1690 0
Conference abstract
Citation/DOI/link/details [3] 1690 0
Gray, K.M., Tonge, B.J., Taffe, J.R., Sanders, M., Sofronoff, K., & Einfeld, S.L. (2017). A
community-based parenting intervention for parents of children with a disability: Outcomes in the Australian Stepping Stones Triple P project. Mental Health Research in Intellectual Disabilities, 10, 140-141.
Attachments [3] 1690 0
Citation type [4] 1691 0
Conference abstract
Citation/DOI/link/details [4] 1691 0
Gray, K., Tonge, B., Taffe, J., Sanders, M., Sofronoff, K., & Einfeld, S. (2016).
Behaviour and emotional problems in children with developmental disabilities: Results from an Australian public health intervention. Journal of Intellectual Disability Research, 60, 674.
Attachments [4] 1691 0
Citation type [5] 1692 0
Conference abstract
Citation/DOI/link/details [5] 1692 0
Gray, K.M., Tonge, B.J., Taffe, J.R., Wilson, R., Einfeld, S.L., Sanders, M., Sofronoff, K.
(2014). Behaviour and emotional problems in children with developmental disabilities: Results of an Australian population level survey. Journal of Applied Research in Intellectual Disabilities, 27(4), 316.
Attachments [5] 1692 0
Citation type [6] 1697 0
Conference abstract
Citation/DOI/link/details [6] 1697 0
Arora, S., Goodall, S., Viney, R., Einfeld, S., (2016). Using a Discrete Choice Experiment to Value Informal Care Provided to Children with Intellectual Disabilities. Value in Health, 19, A905-A906.
Attachments [6] 1697 0
Citation type [7] 1698 0
Conference abstract
Citation/DOI/link/details [7] 1698 0
Tonge, B.J., (2016). The mental health of people with intellectual disabilities: A major public health problem. Invited Master Lecture presented at the 15th World Congress of the International Association for the Scientific Study of Intellectual Disabilities, Melbourne, Australia. Journal of Intellectual Disability Research, 60, 627.
Attachments [7] 1698 0
Results – plain English summary
Summary of findings
• Children’s behaviour and parents’ skills improved when they participated in a Stepping Stones Triple P program.
• The outcomes achieved by community practitioners and organisations were similar to those achieved in previous University located controlled research trials.
• Parenting skills improved by becoming more positive and less coercive.
• Parents’ stress reduced following the program. However, this was not seen in the families with financial hardship.
• Participation in Stepping Stones Triple P helped families financially as they were able to take less time off work.
• Organisations and professionals adopted the program enthusiastically.
• There was a relatively high level of participation - approximately 38 per cent of the population targeted - compared with the 10 per cent who have been shown to access expert help through usual clinical sources.
• Participation of families predominantly came through the disability agencies they were connected with.
• Current funding models for the NDIS will make Stepping Stones Triple P unavailable for most families as there is inadequate funding provision for organisations to deliver group-based programs.