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Trial registered on ANZCTR
Registration number
ACTRN12618001332213
Ethics application status
Approved
Date submitted
1/08/2018
Date registered
7/08/2018
Date last updated
29/06/2021
Date data sharing statement initially provided
24/07/2019
Date results information initially provided
29/06/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Does integrating a parenting support program into paediatric eczema care services improve treatment outcomes? A randomised controlled trial.
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Scientific title
Does integrating a parenting support program into paediatric eczema care services improve treatment outcomes? A randomised controlled trial.
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Secondary ID [1]
295699
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None.
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Universal Trial Number (UTN)
U1111-1218-3441
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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:
Atopic dermatitis (eczema) in children
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Parenting children with atopic dermatitis (eczema)
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Condition category
Condition code
Skin
307959
307959
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0
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Dermatological conditions
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Intervention/exposure
Study type
Interventional
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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 parents discussion group sessions designed to target the direct and indirect pathways of parenting impact on child outcomes - i.e. parenting practices, and parenting confidence and stress. Sessions are held two weeks apart. Program 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. The intervention will be delivered by clinical psychologists and nurses who are accredited Triple P providers.
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Intervention code [1]
302019
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Behaviour
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Intervention code [2]
312079
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Treatment: Other
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Comparator / control treatment
Care as usual. Families allocated to the care as usual condition will continue to receive regular medical management from their dermatology team and usual health practitioners as appropriate. After the final 6-month follow-up assessment families will be offered participation in the program.
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Control group
Active
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Outcomes
Primary outcome [1]
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Disease severity: Atopic dermatitis (eczema) severity will be assessed via visual assessment using the Eczema Area Severity Index (EASI), and via parent-report of symptom severity using the Patient Orientated Eczema Measure (POEM).
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Assessment method [1]
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Timepoint [1]
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Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.
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Primary outcome [2]
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Treatment Adherence: Use of topical eczema medications, assessed using the Medication Event Monitoring System (MEMS) 6 TrackCaps.
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Assessment method [2]
306945
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Timepoint [2]
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Daily adherence will be monitored for the duration of participation in the study, beginning 1 month prior to randomisation and continuing until 6-month follow-up.
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Secondary outcome [1]
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Parenting behaviour, as assessed using the Parenting Scale.
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Assessment method [1]
350185
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Timepoint [1]
350185
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Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.
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Secondary outcome [2]
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Atopic dermatitis (eczema) management, as assessed using the Child Eczema Management Questionnaire.
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Assessment method [2]
350186
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Timepoint [2]
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Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.
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Secondary outcome [3]
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Child behaviour, as assessed using the Eczema Behaviour Checklist.
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Assessment method [3]
350187
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Timepoint [3]
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Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.
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Secondary outcome [4]
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Quality of life, as assessed using the Child Dermatology Life Quality Index (child) and the Dermatitis Family Impact Questionnaire (family).
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Assessment method [4]
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Timepoint [4]
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Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.
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Eligibility
Key inclusion criteria
Parents of 2- to 10-year-old children with eczema who are currently prescribed topical corticosteroids and attending dermatology outpatient clinics at the Lady Cilento Children's Hospital (Brisbane).
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Minimum age
18
Years
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Maximum age
No limit
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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
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 have previously completed Triple P.
The parents have difficulties in reading an English newspaper.
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Study design
Purpose of the study
Educational / counselling / training
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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)
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.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
24/09/2018
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Actual
10/12/2018
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Date of last participant enrolment
Anticipated
20/12/2019
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Actual
2/07/2020
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Date of last data collection
Anticipated
14/01/2021
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Actual
4/02/2021
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Sample size
Target
150
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Accrual to date
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Final
59
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
11551
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Lady Cilento Children's Hospital - South Brisbane
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Recruitment postcode(s) [1]
23579
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4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
300285
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Charities/Societies/Foundations
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Name [1]
300285
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Children's Hospital Foundation
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Address [1]
300285
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494 Stanley Street
South Brisbane QLD 4101
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Country [1]
300285
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Australia
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Primary sponsor type
Individual
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Name
Dr Amy Mitchell
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Address
Menzies Health Institute Queensland
Griffith University
Nathan Campus
Kessels Road
Nathan QLD 4111
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Country
Australia
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Secondary sponsor category [1]
299714
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Individual
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Name [1]
299714
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A/Prof Alina Morawska (Co-Investigator)
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Address [1]
299714
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Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
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Country [1]
299714
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Australia
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Secondary sponsor category [2]
299719
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Individual
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Name [2]
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Ms Emily Casey (Co-Investigator)
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Address [2]
299719
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Department of Dermatology
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
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Country [2]
299719
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Australia
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Secondary sponsor category [3]
299720
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Individual
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Name [3]
299720
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A/Prof Jennifer Fraser (Co-Investigator)
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Address [3]
299720
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Sydney Nursing School
University of Sydney
Sydney NSW 2006
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Country [3]
299720
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Australia
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Secondary sponsor category [4]
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Individual
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Name [4]
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Dr Ania Filus (Co-Investigator)
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Address [4]
299721
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Center for Economic and Social Research
University of Southern California
635 Downey Way
Los Angeles, CA 90089-3332.
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Country [4]
299721
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United States of America
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301096
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Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
301096
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Level 7, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101
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Ethics committee country [1]
301096
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Australia
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Date submitted for ethics approval [1]
301096
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22/01/2018
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Approval date [1]
301096
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01/03/2018
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Ethics approval number [1]
301096
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HREC/18/QRCH/28
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Ethics committee name [2]
301100
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The University of Queensland Human Research Ethics Committee
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Ethics committee address [2]
301100
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Cumbrae-Stewart Building
The University of Queensland
St Lucia QLD 4072
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Ethics committee country [2]
301100
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Australia
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Date submitted for ethics approval [2]
301100
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02/03/2018
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Approval date [2]
301100
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05/03/2018
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Ethics approval number [2]
301100
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2018000449
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Summary
Brief summary
Childhood eczema places an enormous burden on children and families. While good evidence for therapeutic interventions exists, ongoing non-compliance with treatment is common and presents a serious problem, increasing morbidity and impacting quality of life for children and families. Existing approaches have a record of failure in improving adherence. This study will improve clinical outcomes for children with eczema by integrating evidence-based support for parents who rely on existing eczema care services, to improve treatment adherence, reduce disease severity, and improve the quality of life for affected children. A randomised controlled trial will evaluate a brief parenting skills-training program for parents of children with eczema, comparing the intervention with usual care. We expect that this approach, which aims to enhance parental self-efficacy via application of practical parenting skills, will lead to improvements in adherence with medical treatment regimens and better disease control.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Amy Mitchell
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Address
85870
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Menzies Health Institute Queensland, Griffith University, Nathan Campus, Kessels Road, Nathan QLD 4111
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Country
85870
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Australia
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Phone
85870
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+61 7 3735 6462
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Fax
85870
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Email
85870
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[email protected]
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Contact person for public queries
Name
85871
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Dr Amy Mitchell
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Address
85871
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Menzies Health Institute Queensland, Griffith University, Nathan Campus, Kessels Road, Nathan QLD 4111
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Country
85871
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Australia
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Phone
85871
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+61 7 3735 6462
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Fax
85871
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Email
85871
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[email protected]
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Contact person for scientific queries
Name
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Dr Amy Mitchell
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Address
85872
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Menzies Health Institute Queensland, Griffith University, Nathan Campus, Kessels Road, Nathan QLD 4111
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Country
85872
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Australia
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Phone
85872
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+61 7 3735 6462
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Fax
85872
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Email
85872
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
De-identified individual participant data, after removal of sensitive variables from the data set.
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When will data be available (start and end dates)?
Following publication of trial results; no end date determined.
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Available to whom?
Data will be made available to researchers only on the condition of approval from the original research team.
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Available for what types of analyses?
Data collected for this project may be used by the research team or by other researchers for research that is related or unrelated to the current project.
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How or where can data be obtained?
Metadata from this project will be made available through UQ eSpace at the conclusion of the study. Data requests to be made to the research team.
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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.
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