Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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.
Scientific title
Does integrating a parenting support program into paediatric eczema care services improve treatment outcomes? A randomised controlled trial.
Secondary ID [1] 295699 0
None.
Universal Trial Number (UTN)
U1111-1218-3441
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic dermatitis (eczema) in children 309082 0
Parenting children with atopic dermatitis (eczema) 309083 0
Condition category
Condition code
Skin 307959 307959 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 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.
Intervention code [1] 302019 0
Behaviour
Intervention code [2] 312079 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 306944 0
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).
Timepoint [1] 306944 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.
Primary outcome [2] 306945 0
Treatment Adherence: Use of topical eczema medications, assessed using the Medication Event Monitoring System (MEMS) 6 TrackCaps.
Timepoint [2] 306945 0
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.
Secondary outcome [1] 350185 0
Parenting behaviour, as assessed using the Parenting Scale.
Timepoint [1] 350185 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.
Secondary outcome [2] 350186 0
Atopic dermatitis (eczema) management, as assessed using the Child Eczema Management Questionnaire.
Timepoint [2] 350186 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.
Secondary outcome [3] 350187 0
Child behaviour, as assessed using the Eczema Behaviour Checklist.
Timepoint [3] 350187 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.
Secondary outcome [4] 350188 0
Quality of life, as assessed using the Child Dermatology Life Quality Index (child) and the Dermatitis Family Impact Questionnaire (family).
Timepoint [4] 350188 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 6 month follow-up.

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).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
24/09/2018
Actual
10/12/2018
Date of last participant enrolment
Anticipated
20/12/2019
Actual
2/07/2020
Date of last data collection
Anticipated
14/01/2021
Actual
4/02/2021
Sample size
Target
150
Accrual to date
Final
59
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11551 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 23579 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 300285 0
Charities/Societies/Foundations
Name [1] 300285 0
Children's Hospital Foundation
Country [1] 300285 0
Australia
Primary sponsor type
Individual
Name
Dr Amy Mitchell
Address
Menzies Health Institute Queensland
Griffith University
Nathan Campus
Kessels Road
Nathan QLD 4111
Country
Australia
Secondary sponsor category [1] 299714 0
Individual
Name [1] 299714 0
A/Prof Alina Morawska (Co-Investigator)
Address [1] 299714 0
Parenting and Family Support Centre School of Psychology The University of Queensland 13 Upland Road St Lucia QLD 4072
Country [1] 299714 0
Australia
Secondary sponsor category [2] 299719 0
Individual
Name [2] 299719 0
Ms Emily Casey (Co-Investigator)
Address [2] 299719 0
Department of Dermatology Lady Cilento Children's Hospital 501 Stanley Street South Brisbane QLD 4101
Country [2] 299719 0
Australia
Secondary sponsor category [3] 299720 0
Individual
Name [3] 299720 0
A/Prof Jennifer Fraser (Co-Investigator)
Address [3] 299720 0
Sydney Nursing School University of Sydney Sydney NSW 2006
Country [3] 299720 0
Australia
Secondary sponsor category [4] 299721 0
Individual
Name [4] 299721 0
Dr Ania Filus (Co-Investigator)
Address [4] 299721 0
Center for Economic and Social Research University of Southern California 635 Downey Way Los Angeles, CA 90089-3332.
Country [4] 299721 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301096 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 301096 0
Ethics committee country [1] 301096 0
Australia
Date submitted for ethics approval [1] 301096 0
22/01/2018
Approval date [1] 301096 0
01/03/2018
Ethics approval number [1] 301096 0
HREC/18/QRCH/28
Ethics committee name [2] 301100 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 301100 0
Ethics committee country [2] 301100 0
Australia
Date submitted for ethics approval [2] 301100 0
02/03/2018
Approval date [2] 301100 0
05/03/2018
Ethics approval number [2] 301100 0
2018000449

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

Contacts
Principal investigator
Name 85870 0
Dr Amy Mitchell
Address 85870 0
Menzies Health Institute Queensland, Griffith University, Nathan Campus, Kessels Road, Nathan QLD 4111
Country 85870 0
Australia
Phone 85870 0
+61 7 3735 6462
Fax 85870 0
Email 85870 0
[email protected]
Contact person for public queries
Name 85871 0
Amy Mitchell
Address 85871 0
Menzies Health Institute Queensland, Griffith University, Nathan Campus, Kessels Road, Nathan QLD 4111
Country 85871 0
Australia
Phone 85871 0
+61 7 3735 6462
Fax 85871 0
Email 85871 0
[email protected]
Contact person for scientific queries
Name 85872 0
Amy Mitchell
Address 85872 0
Menzies Health Institute Queensland, Griffith University, Nathan Campus, Kessels Road, Nathan QLD 4111
Country 85872 0
Australia
Phone 85872 0
+61 7 3735 6462
Fax 85872 0
Email 85872 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Data will be made available to researchers only on the condition of approval from the original research team.

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified individual participant data, after removal of sensitive variables from the data set.

What types of analyses could be done with individual participant data?
• 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.

When can requests for individual participant data be made (start and end dates)?
From:
Following publication of trial results; no end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• 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.

Are there extra considerations when requesting access to individual participant data?
No


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.