Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001196831
Ethics application status
Approved
Date submitted
12/11/2012
Date registered
13/11/2012
Date last updated
14/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial Evaluating a Brief Parenting Program with Children with Autism Spectrum Disorders
Scientific title
Evaluating improvements in parents of children with Autism Spectrum Disorders who receive a brief parenting program, Primary Care Stepping Stones Triple P, compared to parents in a care-as-usual comparison group on child behaviour problems, dysfunctional parenting styles, parenting confidence, and parental adjustment.
Secondary ID [1] 281526 0
Nil
Universal Trial Number (UTN)
U1111-1136-9519
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorders 287788 0
Condition category
Condition code
Mental Health 288140 288140 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Primary Care Stepping Stones Triple P

Primary Care Stepping Stones Triple P (PCSSTP)is a brief behavioural family intervention consisting of four short sessions targeting one or two specific child problems. Sessions are individually-delivered and designed to last approximately 15-30 minutes with the first three sessions being weekly and the final session occurring 2-4 weeks following the third session. The program is designed to be accessed through primary health care providers e.g., general practitioners, pediatricians, and nurses. The first session involves collecting family background information, discussing the history and nature of the presenting problem/s; and introducing baseline monitoring. Session 2 consists of a review of the assessment information; discussion of the monitoring and parent’s perceptions of the problem; sharing conclusions about the nature and etiology of the problem; setting specific goals for change; and developing a parenting plan. Session 3 includes reviewing progress; discussing any obstacles or difficulties in implementing the parenting plan; and making adjustments to the plan as necessary. Further discussion of strategies or behavioral rehearsal may also be included. Session 4 involves a review of progress with reference to specific goals set; discussion of problems encountered; strategies for maintaining change; and termination of contact.

Parents choose which child problems they wish to target during the course of the intervention which can include a range of emotional, social, behavioural, and developmental problems. The problems are addressed by teaching parents a range of strategies based on social learning theory, research on child and family behaviour therapy, applied behaviour analysis, social information processing models, and developmental research.
Intervention code [1] 286041 0
Behaviour
Comparator / control treatment
Care-as-usual group

This group does not receive any intervention but are free to access any other services as they wish.
Control group
Active

Outcomes
Primary outcome [1] 288341 0
Child behaviour problems as measured by the two scales of the Eyberg Child Behaviour Inventory (ECBI) self-report questionnaire
Timepoint [1] 288341 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [1] 299911 0
Dysfunctional parenting styles as measured by the three subscales of the Parenting Scale self-report questionnaire.
Timepoint [1] 299911 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [2] 299912 0
Parenting confidence as measured by the Parenting Tasks Checklist self-report questionnaire
Timepoint [2] 299912 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [3] 299913 0
Parental adjustment as measured by the DASS-21 self-report questionnaire
Timepoint [3] 299913 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [4] 299914 0
Parenting-specific stress as measured by the Parental Stress Scale self-report questionnaire
Timepoint [4] 299914 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [5] 299915 0
Observed child disruptive behaviour as measured by the percentage of intervals including disruptive child behaviour from a 30-minute home observation coded in 10 second intervals by coders blind to condition.
Timepoint [5] 299915 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [6] 299916 0
Observed aversive parenting behaviours as measured by the percentage of intervals including aversive parent behaviours from a 30-minute home observation coded in 10 second intervals by coders blind to condition.
Timepoint [6] 299916 0
Pre-intervention, post-intervention and 6-month follow-up

Eligibility
Key inclusion criteria
Parents/carers of a child aged between two and nine (at point of first contact) who had an ASD diagnosis (i.e., diagnosis of PDD-NOS, Asperger’s Disorder, Autistic Disorder, or Autism Spectrum Disorder) from a paediatrician or child psychiatrist. Parents needed to be living in the wider Brisbane, Australia metropolitan area. Parents needed to be concerned about social, emotional, behavioral, or developmental problems in their child.
Minimum age
2 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents were excluded from participation if they were currently receiving parenting assistance from another professional.

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)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random assignment to one of two conditions was achieved using a pre-determined computer-generated random-number sequence. Participants were assigned sequentially to condition (in order of contact), stratified for income (above or below the Australian median household income (Australian Bureau of Statistics, 2009)) and child diagnosis (ASD, Autism, Asperger’s Disorder, PDD-NOS). No parties were blinded to group allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5980 0
4000
Recruitment postcode(s) [2] 5981 0
4004
Recruitment postcode(s) [3] 5982 0
4006
Recruitment postcode(s) [4] 5983 0
4007
Recruitment postcode(s) [5] 5984 0
4009
Recruitment postcode(s) [6] 5985 0
4010
Recruitment postcode(s) [7] 5986 0
4011
Recruitment postcode(s) [8] 5987 0
4012
Recruitment postcode(s) [9] 5988 0
4013
Recruitment postcode(s) [10] 5989 0
4014
Recruitment postcode(s) [11] 5990 0
4017
Recruitment postcode(s) [12] 5991 0
4022
Recruitment postcode(s) [13] 5992 0
4030
Recruitment postcode(s) [14] 5993 0
4031
Recruitment postcode(s) [15] 5994 0
4032
Recruitment postcode(s) [16] 5995 0
4034
Recruitment postcode(s) [17] 5996 0
4035
Recruitment postcode(s) [18] 5997 0
4037
Recruitment postcode(s) [19] 5998 0
4051
Recruitment postcode(s) [20] 5999 0
4053
Recruitment postcode(s) [21] 6000 0
4055
Recruitment postcode(s) [22] 6001 0
4061
Recruitment postcode(s) [23] 6002 0
4066
Recruitment postcode(s) [24] 6003 0
4068
Recruitment postcode(s) [25] 6004 0
4069
Recruitment postcode(s) [26] 6005 0
4073
Recruitment postcode(s) [27] 6006 0
4074
Recruitment postcode(s) [28] 6007 0
4075
Recruitment postcode(s) [29] 6008 0
4077
Recruitment postcode(s) [30] 6009 0
4101
Recruitment postcode(s) [31] 6010 0
4103
Recruitment postcode(s) [32] 6011 0
4107
Recruitment postcode(s) [33] 6012 0
4113
Recruitment postcode(s) [34] 6013 0
4114
Recruitment postcode(s) [35] 6014 0
4129
Recruitment postcode(s) [36] 6015 0
4130
Recruitment postcode(s) [37] 6016 0
4178
Recruitment postcode(s) [38] 6017 0
4505
Recruitment postcode(s) [39] 6018 0
4500
Recruitment postcode(s) [40] 6019 0
4508
Recruitment postcode(s) [41] 6020 0
4054
Recruitment postcode(s) [42] 6021 0
4059
Recruitment postcode(s) [43] 6022 0
4060
Recruitment postcode(s) [44] 6023 0
4064
Recruitment postcode(s) [45] 6024 0
4065
Recruitment postcode(s) [46] 6025 0
4067
Recruitment postcode(s) [47] 6026 0
4070
Recruitment postcode(s) [48] 6027 0
4105

Funding & Sponsors
Funding source category [1] 286307 0
University
Name [1] 286307 0
The University of Queensland
Country [1] 286307 0
Australia
Primary sponsor type
Individual
Name
Cassandra Tellegen
Address
Parenting and Family Support Centre
The University of Queensland
St Lucia, Qld 4067
Country
Australia
Secondary sponsor category [1] 285095 0
Individual
Name [1] 285095 0
Professor Matthew Sanders
Address [1] 285095 0
Parenting and Family Support Centre
The University of Queensland
St Lucia, Qld 4067
Country [1] 285095 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288378 0
Behavioural and Social Sciences Ethical Review Committee
Ethics committee address [1] 288378 0
The Office of Research and Postgraduate Studies
Cumbrae-Stewart Bldg (72)
THE UNIVERSITY OF QUEENSLAND St Lucia, QLD 4072
Ethics committee country [1] 288378 0
Australia
Date submitted for ethics approval [1] 288378 0
Approval date [1] 288378 0
01/09/2009
Ethics approval number [1] 288378 0
2009001213

Summary
Brief summary
This randomized controlled trial evaluated Primary Care Stepping Stones Triple P, a brief individualized parenting program, in a sample of parents of children with Autism Spectrum Disorder (ASD). It was hypothesised that parents who took part in the program would experience improvements in child behaviour problems, parenting styles, parenting confidence and parental adjustment.
Trial website
https://experiment.psy.uq.edu.au/pcsteppingstones/
Trial related presentations / publications
Tellegen, C. L. & Sanders, M. R. (2012) Using Primary Care Parenting Interventions to Improve Outcomes in Children with Developmental Disabilities: A Case Report, 2012, doi:10.1155/2012/150261

Tellegen, C. L. (2012). Evaluation of a Brief Behavioural Family Intervention with Parents of Children with an Autism Spectrum Disorder: Findings from a Randomised Controlled Trial. Paper presented at 35th Australian Association for Cognitive Behavioural Therapy National Conference. Gold Coast: Australia.

Tellegen, C.L. (2012). Outcomes from a randomised controlled trial evaluating a brief intervention with parents of children with Autism Spectrum Disorder. Paper presented at the 14th Helping Families Change Conference. Glasgow: Scotland.

Tellegen, C.L. (2011). Initial findings from a randomised controlled trial evaluating Primary Care Stepping Stones Triple P. Paper presented at the 13th Helping Families Change Conference. Antwerp: Belgium.
Public notes

Contacts
Principal investigator
Name 34939 0
Address 34939 0
Country 34939 0
Phone 34939 0
Fax 34939 0
Email 34939 0
Contact person for public queries
Name 18186 0
Cassandra Tellegen
Address 18186 0
Parenting and Family Support Centre
The University of Queensland
St Lucia, Qld, 4067
Country 18186 0
Australia
Phone 18186 0
+61 7 3365 8870
Fax 18186 0
Email 18186 0
[email protected]
Contact person for scientific queries
Name 9114 0
Cassandra Tellegen
Address 9114 0
Parenting and Family Support Centre
The University of Queensland
St Lucia, Qld, 4067
Country 9114 0
Australia
Phone 9114 0
+61 7 3365 8870
Fax 9114 0
Email 9114 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
SourceTitleYear of PublicationDOI
EmbaseA randomized controlled trial evaluating a brief parenting program with children with autism spectrum disorders.2014http://dx.doi.org/10.1037/a0037246
N.B. These documents automatically identified may not have been verified by the study sponsor.