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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
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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.
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Secondary ID [1]
281526
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Nil
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Universal Trial Number (UTN)
U1111-1136-9519
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorders
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Condition category
Condition code
Mental Health
288140
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0
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Autistic spectrum disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
286041
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Child behaviour problems as measured by the two scales of the Eyberg Child Behaviour Inventory (ECBI) self-report questionnaire
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Assessment method [1]
288341
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Timepoint [1]
288341
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Pre-intervention, post-intervention and 6-month follow-up
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Secondary outcome [1]
299911
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Dysfunctional parenting styles as measured by the three subscales of the Parenting Scale self-report questionnaire.
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Assessment method [1]
299911
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Timepoint [1]
299911
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Pre-intervention, post-intervention and 6-month follow-up
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Secondary outcome [2]
299912
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Parenting confidence as measured by the Parenting Tasks Checklist self-report questionnaire
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Assessment method [2]
299912
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Timepoint [2]
299912
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Pre-intervention, post-intervention and 6-month follow-up
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Secondary outcome [3]
299913
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Parental adjustment as measured by the DASS-21 self-report questionnaire
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Assessment method [3]
299913
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Timepoint [3]
299913
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Pre-intervention, post-intervention and 6-month follow-up
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Secondary outcome [4]
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Parenting-specific stress as measured by the Parental Stress Scale self-report questionnaire
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Assessment method [4]
299914
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Timepoint [4]
299914
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Pre-intervention, post-intervention and 6-month follow-up
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Secondary outcome [5]
299915
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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.
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Assessment method [5]
299915
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Timepoint [5]
299915
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Pre-intervention, post-intervention and 6-month follow-up
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Secondary outcome [6]
299916
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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.
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Assessment method [6]
299916
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Timepoint [6]
299916
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Pre-intervention, post-intervention and 6-month follow-up
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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.
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Minimum age
2
Years
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Maximum age
9
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Parents were excluded from participation if they were currently receiving parenting assistance from another professional.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
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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.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
22/03/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
62
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment postcode(s) [1]
5980
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4000
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Recruitment postcode(s) [2]
5981
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4004
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Recruitment postcode(s) [3]
5982
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4006
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Recruitment postcode(s) [4]
5983
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4007
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Recruitment postcode(s) [5]
5984
0
4009
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Recruitment postcode(s) [6]
5985
0
4010
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Recruitment postcode(s) [7]
5986
0
4011
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Recruitment postcode(s) [8]
5987
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4012
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Recruitment postcode(s) [9]
5988
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4013
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Recruitment postcode(s) [10]
5989
0
4014
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Recruitment postcode(s) [11]
5990
0
4017
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Recruitment postcode(s) [12]
5991
0
4022
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Recruitment postcode(s) [13]
5992
0
4030
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Recruitment postcode(s) [14]
5993
0
4031
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Recruitment postcode(s) [15]
5994
0
4032
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Recruitment postcode(s) [16]
5995
0
4034
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Recruitment postcode(s) [17]
5996
0
4035
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Recruitment postcode(s) [18]
5997
0
4037
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Recruitment postcode(s) [19]
5998
0
4051
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Recruitment postcode(s) [20]
5999
0
4053
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Recruitment postcode(s) [21]
6000
0
4055
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Recruitment postcode(s) [22]
6001
0
4061
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Recruitment postcode(s) [23]
6002
0
4066
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Recruitment postcode(s) [24]
6003
0
4068
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Recruitment postcode(s) [25]
6004
0
4069
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Recruitment postcode(s) [26]
6005
0
4073
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Recruitment postcode(s) [27]
6006
0
4074
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Recruitment postcode(s) [28]
6007
0
4075
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Recruitment postcode(s) [29]
6008
0
4077
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Recruitment postcode(s) [30]
6009
0
4101
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Recruitment postcode(s) [31]
6010
0
4103
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Recruitment postcode(s) [32]
6011
0
4107
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Recruitment postcode(s) [33]
6012
0
4113
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Recruitment postcode(s) [34]
6013
0
4114
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Recruitment postcode(s) [35]
6014
0
4129
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Recruitment postcode(s) [36]
6015
0
4130
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Recruitment postcode(s) [37]
6016
0
4178
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Recruitment postcode(s) [38]
6017
0
4505
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Recruitment postcode(s) [39]
6018
0
4500
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Recruitment postcode(s) [40]
6019
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4508
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Recruitment postcode(s) [41]
6020
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4054
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Recruitment postcode(s) [42]
6021
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4059
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Recruitment postcode(s) [43]
6022
0
4060
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Recruitment postcode(s) [44]
6023
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4064
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Recruitment postcode(s) [45]
6024
0
4065
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Recruitment postcode(s) [46]
6025
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4067
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Recruitment postcode(s) [47]
6026
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4070
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Recruitment postcode(s) [48]
6027
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4105
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Funding & Sponsors
Funding source category [1]
286307
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University
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Name [1]
286307
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The University of Queensland
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Address [1]
286307
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St Lucia, Qld 4067
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Country [1]
286307
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Australia
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Primary sponsor type
Individual
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Name
Cassandra Tellegen
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Address
Parenting and Family Support Centre
The University of Queensland
St Lucia, Qld 4067
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Country
Australia
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Secondary sponsor category [1]
285095
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Individual
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Name [1]
285095
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Professor Matthew Sanders
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Address [1]
285095
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Parenting and Family Support Centre
The University of Queensland
St Lucia, Qld 4067
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Country [1]
285095
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288378
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Behavioural and Social Sciences Ethical Review Committee
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Ethics committee address [1]
288378
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The Office of Research and Postgraduate Studies Cumbrae-Stewart Bldg (72) THE UNIVERSITY OF QUEENSLAND St Lucia, QLD 4072
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Ethics committee country [1]
288378
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Australia
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Date submitted for ethics approval [1]
288378
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Approval date [1]
288378
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01/09/2009
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Ethics approval number [1]
288378
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2009001213
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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.
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Trial website
https://experiment.psy.uq.edu.au/pcsteppingstones/
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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.
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Public notes
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Contacts
Principal investigator
Name
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Address
34939
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Country
34939
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Phone
34939
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Fax
34939
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Email
34939
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Contact person for public queries
Name
18186
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Cassandra Tellegen
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Address
18186
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Parenting and Family Support Centre
The University of Queensland
St Lucia, Qld, 4067
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Country
18186
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Australia
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Phone
18186
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+61 7 3365 8870
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Fax
18186
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Email
18186
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[email protected]
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Contact person for scientific queries
Name
9114
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Cassandra Tellegen
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Address
9114
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Parenting and Family Support Centre
The University of Queensland
St Lucia, Qld, 4067
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Country
9114
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Australia
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Phone
9114
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+61 7 3365 8870
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Fax
9114
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Email
9114
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
A randomized controlled trial evaluating a brief parenting program with children with autism spectrum disorders.
2014
http://dx.doi.org/10.1037/a0037246
N.B. These documents automatically identified may not have been verified by the study sponsor.
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