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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]

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

Intellectual disability

Autism Spectrum Disorders (including autism, Autistic Disorder, Asperger's Disorder, PDD-NOS)

Neurological, motor, or sensory disability

Child behavioural and emotional problems

Parenting practices and self-efficacy

Condition category

Condition code

Mental Health

Other mental health disorders

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Public Health

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]

Treatment: Other

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

For the entire target population (including the sub-sample): Baseline and at 3 months and 15 months after baseline.

Secondary outcome [1]

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]

For the entire target population (including the sub-sample): Baseline and at 3 months and 15 months after baseline.

Secondary outcome [2]

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]

For the entire target population (including the sub-sample): Baseline and at 3 months and 15 months after baseline.

Secondary outcome [3]

Secondary Outcome 4: Parenting conflict.

This will be assessed by total scores on the Parent Problem Checklist.

Timepoint [3]

For the sub-sample only: Baseline and at 3 months and 15 months after baseline.

Secondary outcome [4]

Secondary Outcome 5: Parent anxiety, depression and stress.

This will be assessed by scores on the Depression Anxiety Stress Scales (DASS-21).

Timepoint [4]

For the sub-sample only: Baseline and at 3 months and 15 months after baseline.

Secondary outcome [5]

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]

For the entire target population (including the sub-sample): Baseline and at 3 months and 15 months after baseline.

Secondary outcome [6]

Secondary Outcome 7: Parent satisfaction with program delivery.

This will be assessed by responses on the Client Satisfaction Questionnaire (CSQ)

Timepoint [6]

After receiving an SSTP intervention. For all groups, this measure will be collected 3 months after commencing a SSTP intervention program.

Secondary outcome [7]

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]

Parent Consultation Skills Checklist was completed before and after training, and at accreditation.

Secondary outcome [8]

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]

For the sub-sample only: Baseline and at 3 months and 15 months after baseline.

Secondary outcome [9]

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]

For the sub-sample only: Baseline and at 3 months and 15 months after baseline.

Secondary outcome [10]

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]

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

Sex

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

10/07/2013

Actual

25/07/2013

Date of last participant enrolment

Anticipated

31/12/2016

Actual

22/07/2017

Date of last data collection

Anticipated

Actual

22/12/2017

Sample size

Target

2100

Accrual to date

Final

2259

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

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]

University

Name [1]

The University of Queensland

Address [1]

Professor Matthew Sanders
Parenting and Family Support Centre
School of Psychology
The University of Queensland
Brisbane
QLD 4072

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

Monash University

Address [2]

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]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Sydney Human Ethics Research Committee

Ethics committee address [1]

Level 6, Jane Foss Russell Building - G02
The University of Sydney
NSW 2006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/03/2012

Approval date [1]

09/05/2012

Ethics approval number [1]

14710

Ethics committee name [2]

The University of Queensland Behavioural & Social Sciences Ethical Review Committee

Ethics committee address [2]

The Office of Research and Postgraduate Studies 
Cumbrae-Stewart Bldg (72) 
THE UNIVERSITY OF QUEENSLAND 
Brisbane
QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

10/09/2012

Approval date [2]

20/09/2012

Ethics approval number [2]

2012001065

Ethics committee name [3]

Monash University Human Research Ethics Committee

Ethics committee address [3]

Monash Research Office
Building 3d
Monash University
Victoria 3800

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

05/02/2013

Approval date [3]

10/04/2013

Ethics approval number [3]

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

Prof Stewart L. Einfeld

Address

Brain & Mind Research Institute
94 Mallett Street
Camperdown
NSW 2050

Country

Australia

Phone

+61 2 93510885

Fax

[email protected]

Contact person for public queries

Name

Kylie Gray

Address

Centre for Developmental Psychiatry and Psychology
Monash Medical Centre
246 Clayton Rd
Clayton, VIC 3168

Country

Australia

Phone

+61 3 9594 1300

Fax

[email protected]

Contact person for scientific queries

Name

Stewart L. Einfeld

Address

Brain & Mind Research Institute
94 Mallett Street
Camperdown
NSW 2050

Country

Australia

Phone

+61 2 93510885

Fax

[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

Type	Is Peer Reviewed?	Citations or Other Details
Plain language summary	No	Summary of findings • Children’s behaviour and pa... [More Details]
Study results article	Yes	Mazzucchelli, T.G., Hodges, J., Kanea, R.T., Sofro... [More Details]
Study results article	Yes	Teague, S.J., Newman, L.K., Tonge, B.J., Gray, K.M... [More Details]
Study results article	Yes	Bezzina, L.A., Rice, L.J., Howlin, P., Tonge, B.J.... [More Details]
Study results article	Yes	Arora, S., Goodall, S., Viney, R., Einfeld, S. (20... [More Details]
Study results article	Yes	Aery, Anagha, Julie Hodges, and Jamin Day. "The Ef... [More Details]
Other files	No	Book Chapter Sofronoff, K., Gray, K., Einfeld, ... [More Details]
Conference abstract	No	Gray, K.M., Hu, N., Tonge, B.J., Taffe, J.R., Sand... [More Details]
Conference abstract	No	Gray, K.M., Tonge, B.J., Taffe, J.R., Sanders, M.,... [More Details]
Conference abstract	No	Gray, K., Tonge, B., Taffe, J., Sanders, M., Sofro... [More Details]
Conference abstract	No	Gray, K.M., Tonge, B.J., Taffe, J.R., Wilson, R., ... [More Details]
Study results article	Yes	Hinton, S., Sheffield, J., Sanders, M. R., & Sofro... [More Details]
Study results article	Yes	Emser, T. S., Mazzucchelli, T. G., Christiansen, H... [More Details]
Study results article	Yes	Tonge et al. (2017). Mental health and mental disa... [More Details]
Study results article	Yes	Rice, L. J., Emerson, E., Gray, K. M., Howlin, P.,... [More Details]
Other files	No	Arora, S., Goodall, S., Viney, R., Einfeld, S., (2... [More Details]
Conference abstract	No	Tonge, B.J., (2016). The mental health of people w... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Health-related quality of life amongst primary caregivers of children with intellectual disability.	2020	https://dx.doi.org/10.1111/jir.12701
Embase	Societal cost of childhood intellectual disability in Australia.	2020	https://dx.doi.org/10.1111/jir.12732

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically