Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000558921
Ethics application status
Approved
Date submitted
30/05/2011
Date registered
1/06/2011
Date last updated
27/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of a brief parenting intervention for parents of children suffering asthma or eczema
Scientific title
For parents of children suffering asthma or eczema, does participation in a brief parenting intervention, compared to care as usual, decrease use of ineffective parenting strategies, increase parenting confidence, reduce child behavioural and emotional problems, and increase children's quality of life?
Secondary ID [1] 262273 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parenting children with asthma 267974 0
Parenting children with eczema 267975 0
Condition category
Condition code
Respiratory 268105 268105 0 0
Asthma
Skin 268106 268106 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Positive Parenting for Healthy Living Triple P" is a brief parent education and skills-training program that combines parenting information about child behaviour and illness management with the provision of illness relevant information. The intervention consists of two, 2-hour group seminars designed to target the direct and indirect pathways of parenting impact on child outcomes - i.e. parenting practices, and parenting confidence and stress. Seminars are delivered two weeks apart. Seminar content draws on the theoretical principles that form the basis of the well-established Triple P program, which is a preventively orientated parenting and family support strategy derived from social-learning, functional analysis, and cognitive-behavioural principles.
Intervention code [1] 266663 0
Behaviour
Comparator / control treatment
Care as usual. Families allocated to the care as usual condition will continue to receive regular medical managment from their primary care physician, as appropriate. After the final 6-month follow-up assessment families will be offered participation in the program.
Control group
Active

Outcomes
Primary outcome [1] 266855 0
Use of observed and parent-reported effective and ineffective parenting practices, as assessed using the Parenting Scale and direct observation of parent behaviour by researchers.
Timepoint [1] 266855 0
Baseline, and at 4 weeks and 6 months after completion of the intervention.
Primary outcome [2] 266856 0
Parenting confidence, as assessed using the Asthma Parent Tasks Checklist and the Parents' Self-Efficacy with Eczema Care Index.
Timepoint [2] 266856 0
Baseline, and at 4 weeks and 6 months after completion of the intervention.
Primary outcome [3] 266857 0
Observed and parent-reported child behavioural and emotional problems, as assessed using the Asthma Behaviour Checklist, the Eczema Behaviour Checklist, the Eyberg Child Behaviour Inventory, the Child Adjustment and Parent Efficacy Scale (Emotional Symptoms Subscale), and direct observation of child behaviour by researchers.
Timepoint [3] 266857 0
Baseline, and at 4 weeks and 6 months after completion of the intervention.
Secondary outcome [1] 276507 0
Child and family quality of life, as assessed using the PedsQL Generic Core Scale and PedsQL Family Impact Module.
Timepoint [1] 276507 0
Baseline, and at 4 weeks and 6 months after completion of the intervention.

Eligibility
Key inclusion criteria
Parents of children with asthma and/or eczema (aged 3 to 10 years) who are concerned about the child's behaviour or emotions, or their illness management.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The child has a disability including language and speech impairment.
The parents are currently seeing a professional for the child's behaviour difficulties.
The parents are currently receiving psychological help or counselling.
The parents are intellectually disabled.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligibility for participation will be assessed on the basis of a standard telephone screening interview. A pre-prepared series of sealed opaque envelopes will be used to conceal group allocation from both researchers and participants until after the completion of baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation of participants will be done using a random allocation sequence, generated using a computer-based random number generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2011
Actual
30/06/2011
Date of last participant enrolment
Anticipated
Actual
12/07/2013
Date of last data collection
Anticipated
Actual
26/05/2014
Sample size
Target
150
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 267156 0
Government body
Name [1] 267156 0
Australian Research Council
Country [1] 267156 0
Australia
Primary sponsor type
Individual
Name
Dr Alina Morawska (Principal Investigator)
Address
Deputy Director (Research)
Parenting and Family Support Centre
School of Psychology
The University of Queensland
ST LUCIA QLD 4072
Country
Australia
Secondary sponsor category [1] 266230 0
Individual
Name [1] 266230 0
Prof Matthew Sanders (Co-Investigator)
Address [1] 266230 0
Director
Parenting and Family Support Centre
School of Psychology
The University of Queensland
ST LUCIA QLD 4072
Country [1] 266230 0
Australia
Secondary sponsor category [2] 266231 0
Individual
Name [2] 266231 0
A/Prof Jennifer Fraser (Co-Investigator)
Address [2] 266231 0
Director, Research Students and Research Development
MO2 - Sydney Nursing School
University of Sydney
SYDNEY NSW 2006
Country [2] 266231 0
Australia
Secondary sponsor category [3] 266232 0
Individual
Name [3] 266232 0
Dr Scott Burgess
Address [3] 266232 0
Department of Respiratory Medicine
Mater Children's Hospital
Raymond Terrace
SOUTH BRISBANE QLD 4101
Country [3] 266232 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269145 0
Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [1] 269145 0
Ethics committee country [1] 269145 0
Australia
Date submitted for ethics approval [1] 269145 0
Approval date [1] 269145 0
01/12/2010
Ethics approval number [1] 269145 0
2010001427

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

Contacts
Principal investigator
Name 32671 0
A/Prof Alina Morawska
Address 32671 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
Country 32671 0
Australia
Phone 32671 0
+61 7 3365 7304
Fax 32671 0
Email 32671 0
[email protected]
Contact person for public queries
Name 15918 0
Amy Mitchell (Research Coordinator)
Address 15918 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
Country 15918 0
Australia
Phone 15918 0
+61 7 3346 1202
Fax 15918 0
+61 7 3365 6724
Email 15918 0
[email protected]
Contact person for scientific queries
Name 6846 0
Amy Mitchell
Address 6846 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
Country 6846 0
Australia
Phone 6846 0
+61 7 3346 1202
Fax 6846 0
+61 7 3365 6724
Email 6846 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
EmbaseEffects of Triple P parenting intervention on child health outcomes for childhood asthma and eczema: Randomised controlled trial.2016https://dx.doi.org/10.1016/j.brat.2016.06.001
N.B. These documents automatically identified may not have been verified by the study sponsor.