Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000166572
Ethics application status
Approved
Date submitted
30/01/2015
Date registered
19/02/2015
Date last updated
19/02/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial comparing a brief and standard parenting intervention for toddler externalising and aggressive behaviours
Scientific title
Evaluating improvements in families who are randomised to receive a brief parent discussion group versus a standard group parenting program (both Triple P- Positive Parenting Program), as compared to a waitlist control group on child externalising and aggressive behaviour, dysfunctional parenting, parenting efficacy, parent relationship satisfaction and parental adjustment.
Secondary ID [1] 286058 0
Nil
Universal Trial Number (UTN)
Nil known
Trial acronym
ToPP (Toddler Positive Parenting) Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Toddler aggressive behaviour 294039 0
Toddler externalising behaviour 294040 0
Condition category
Condition code
Mental Health 294343 294343 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Standard duration parenting intervention is the 8 session Group Triple P Program. This behavioural family intervention involves 2-hour group sessions held once a week for four weeks, followed by 20-minute individual telephone sessions, also once a week for four weeks. The four group sessions focus on the following topics: positive parenting, helping children develop, managing misbehaviour and planning ahead for high risk situations. These four sessions cover 17 core positive parenting strategies. The group program involves active skills training to teach parents these key parenting strategies, including videotaped modelling of skills, roleplay, rehearsal and feedback. The group sessions are followed by telephone discussions to assist parents to implement the skills learnt in the program. This intervention will be facilitated by a registered psychologist who is also an accredited Triple P Practitioner.

The brief duration parenting intervention is the Triple P Parent Discussion Group focussing specifically on how to manage fighting and aggression. This intervention involves a single two-hour group session followed by 20-minute telephone sessions, held once a week for two weeks. The group session covers 8 positive parenting strategies and involves videotaped modelling of key parenting skills and some roleplay, but does not include the extensive roleplay, rehearsal and feedback of the standard duration intervention. This intervention will be facilitated by the same registered psychologist and Triple P Practitioner as for the standard intervention.
Intervention code [1] 291068 0
Behaviour
Comparator / control treatment
Waitlist control group - Families in the waitlist control group wait for an 8 week period before choosing which parenting intervention to participate in.
Control group
Active

Outcomes
Primary outcome [1] 294175 0
Child aggressive behavior problems as measured by the parent-rated Physical Aggression Scale for Early Childhood (PA-SEC)
Timepoint [1] 294175 0
Pre-intervention, Post-intervention and 6-month follow-up
Secondary outcome [1] 312693 0
Dysfunctional parenting as measured by the three subscales of the Parenting Scale parent-report measure: Laxness, Overreactivity and Verbosity
Timepoint [1] 312693 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [2] 312694 0
Parenting self-efficacy as measured by the Parenting Tasks Checklist parent-report measure: Behavioural self-efficacy scale
Timepoint [2] 312694 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [3] 312695 0
Parental negative affect as measured by the DASS-21 parent-report questionnaire
Timepoint [3] 312695 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [4] 312696 0
Parent relationship satisfaction as measured by the parent-rated Quality of Marriage Index
Timepoint [4] 312696 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [5] 312697 0
Observed child disruptive behavior as measured by the percentage of intervals with disruptive child behavior from a 20 minute clinic videotaped parent-child observation, coded in 10 second intervals by trained coders who were blind to condition .
Timepoint [5] 312697 0
Pre-intervention, post-intervention and 6-month follow-up
Secondary outcome [6] 312698 0
Observed parent aversive behavior as measured by the percentage of intervals with aversive parent behavior from a 20 minute clinic videotaped parent-child observation, coded in 10 second intervals by trained coders who were blind to condition.
Timepoint [6] 312698 0
Pre-intervention, post-intervention and 6-month follow-up

Eligibility
Key inclusion criteria
Parents or carers of a child aged two or three years who are concerned about their child's aggression, and the child scores one standard deviation above the mean on the Physical Aggression Scale for Early Childhood. Parents need to be living in Sydney and able to attend group sessions at the University of Sydney.
Minimum age
2 Years
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents are excluded from participating if they had previously participated in a Triple P Program; if they are receiving (or planning to receive) parenting assistance from another professional; if parents are not able to complete the questionnaires in English; and if the child has a developmental delay (other than a language delay), disability or chronic illness.

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)
The allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Families are randomly assigned to one of three conditions using the next sequential opaque envelope technique (Doig & Simpson, 2005). The method of sequence generation was simple randomisation using a randomisation table.
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
Analysis of covariance and multivariate analyses of covariance
A power calculation was conducted using G*Power 3.1 (Faul, Erdfelder, Lang & Buchner, 2007). A sample size of 72 families (24 per group) was estimated to be sufficient to detect a large effect size for 3 group analysis of variance (power=0.80; alpha = 0.05).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2011
Actual
1/04/2011
Date of last participant enrolment
Anticipated
1/10/2012
Actual
19/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
69
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290667 0
University
Name [1] 290667 0
The University of Sydney
Country [1] 290667 0
Australia
Primary sponsor type
Individual
Name
Lucy Tully
Address
School of Psychology
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 289360 0
Individual
Name [1] 289360 0
Associate Professor Caroline Hunt
Address [1] 289360 0
School of Psychology
The University of Sydney
Camperdown, NSW 2006
Country [1] 289360 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292296 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 292296 0
Ethics committee country [1] 292296 0
Australia
Date submitted for ethics approval [1] 292296 0
Approval date [1] 292296 0
19/08/2010
Ethics approval number [1] 292296 0
12989

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54430 0
A/Prof Caroline Hunt
Address 54430 0
School of Psychology, University of Sydney
Camperdown, Sydney NSW 2006
Country 54430 0
Australia
Phone 54430 0
+61 439723814
Fax 54430 0
Email 54430 0
[email protected]
Contact person for public queries
Name 54431 0
Lucy Tully
Address 54431 0
School of Psychology, University of Sydney
Camperdown, Sydney NSW 2006
Country 54431 0
Australia
Phone 54431 0
+61 439723814
Fax 54431 0
Email 54431 0
[email protected]
Contact person for scientific queries
Name 54432 0
Lucy Tully
Address 54432 0
School of Psychology, University of Sydney
Camperdown, Sydney NSW 2006
Country 54432 0
Australia
Phone 54432 0
+61439723814
Fax 54432 0
Email 54432 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
No additional documents have been identified.