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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
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] 287220 0
Government body
Name [1] 287220 0
National Health and Medical Research Council
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
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
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
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
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
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
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Summary of findings • Children’s behaviour and pa... [More Details]
Study results articleYes Mazzucchelli, T.G., Hodges, J., Kanea, R.T., Sofro... [More Details]
Study results articleYes Teague, S.J., Newman, L.K., Tonge, B.J., Gray, K.M... [More Details]
Study results articleYes Bezzina, L.A., Rice, L.J., Howlin, P., Tonge, B.J.... [More Details]
Study results articleYes Arora, S., Goodall, S., Viney, R., Einfeld, S. (20... [More Details]
Study results articleYes Aery, Anagha, Julie Hodges, and Jamin Day. "The Ef... [More Details]
Other filesNo Book Chapter Sofronoff, K., Gray, K., Einfeld, ... [More Details]
Conference abstractNo Gray, K.M., Hu, N., Tonge, B.J., Taffe, J.R., Sand... [More Details]
Conference abstractNo Gray, K.M., Tonge, B.J., Taffe, J.R., Sanders, M.,... [More Details]
Conference abstractNo Gray, K., Tonge, B., Taffe, J., Sanders, M., Sofro... [More Details]
Conference abstractNo Gray, K.M., Tonge, B.J., Taffe, J.R., Wilson, R., ... [More Details]
Study results articleYes Hinton, S., Sheffield, J., Sanders, M. R., & Sofro... [More Details]
Study results articleYes Emser, T. S., Mazzucchelli, T. G., Christiansen, H... [More Details]
Study results articleYes Tonge et al. (2017). Mental health and mental disa... [More Details]
Study results articleYes Rice, L. J., Emerson, E., Gray, K. M., Howlin, P.,... [More Details]
Other filesNo Arora, S., Goodall, S., Viney, R., Einfeld, S., (2... [More Details]
Conference abstractNo Tonge, B.J., (2016). The mental health of people w... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHealth-related quality of life amongst primary caregivers of children with intellectual disability.2020https://dx.doi.org/10.1111/jir.12701
EmbaseSocietal cost of childhood intellectual disability in Australia.2020https://dx.doi.org/10.1111/jir.12732
N.B. These documents automatically identified may not have been verified by the study sponsor.