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Trial registered on ANZCTR


Registration number
ACTRN12621001692820
Ethics application status
Approved
Date submitted
9/11/2021
Date registered
10/12/2021
Date last updated
10/12/2021
Date data sharing statement initially provided
10/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an online parenting intervention improve outcomes for children with eczema? A pilot study
Scientific title
Can an online parenting intervention improve outcomes for children with eczema? A pilot study
Secondary ID [1] 305753 0
None.
Universal Trial Number (UTN)
U1111-1271-3471
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic dermatitis (eczema) in children 324247 0
Parenting children with atopic dermatitis (eczema) 324248 0
Condition category
Condition code
Skin 321743 321743 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
"Healthy Living Triple P" is a brief parent education and skills-training program developed for families of children with a chronic health conditon. The online version of the program comprises eight interactive online modules delivered via EdX. Modules explore the impacts of children’s chronic illness on child, parent, and family; help parents to identify parenting challenges; and support parents to identify goals for change. They provide parents with strategies to prevent/manage problems with illness management and child behaviour and promote treatment adherence. They also introduce principles of positive parenting to promote positive parenting practices and environments conducive to caring relationships between parents and children, including a discussion of why children with chronic health conditions are at risk of behaviour problems. Finally, they examine common parenting traps and the use of effective parenting and discipline strategies. Modules incorporate written text, video material, interactive exercises, and downloadable tip sheets. Parents progress through the material at their own pace over a two-week period; can return to previously completed modules; and can download the written material and completed exercises.

Families allocated to the intervention group will also receive standardised education about their child’s eczema via an online eczema education module, which provides up-to-date, evidence-based information about aetiology of eczema, signs and symptoms, triggers, treatment options, and management tips and strategies.

Website analytics will be used to assess intervention engagement - number of modules accessed/completed, time taken, and exercises completed.
Intervention code [1] 322156 0
Behaviour
Comparator / control treatment
Families allocated to care-as-usual will receive standardised education about their child’s eczema via an online eczema education module, designed for use in this study, which provides up-to-date, evidence-based information about aetiology of eczema, signs and symptoms, triggers, treatment options, and management tips and strategies. Families will be asked to complete the online eczema education module within a 2 week period. After the final 3-month follow-up assessment familes will be provided with access to the Healthy Living Triple P modules.
Control group
Active

Outcomes
Primary outcome [1] 329498 0
Parenting behaviour, as assessed using the Parenting Scale.
Timepoint [1] 329498 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3 month follow-up.
Primary outcome [2] 329499 0
Atopic dermatitis (eczema) management, as assessed using the Child Eczema Management Questionnaire.
Timepoint [2] 329499 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3 month follow-up.
Secondary outcome [1] 402786 0
Child behaviour, as assessed using the Eczema Behaviour Checklist.
Timepoint [1] 402786 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3 month follow-up.
Secondary outcome [2] 402787 0
Impact of eczema on child quality of life, as assessed using the Child Dermatology Life Quality Index (4-10 year olds) or Infants' Dermatitis Quality of Life Index (2-3 year olds).
Timepoint [2] 402787 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3 month follow-up.
Secondary outcome [3] 402788 0
Impact of eczema on family quality of life, as assessed using the Dermatitis Family Impact Questionnaire.
Timepoint [3] 402788 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3 month follow-up.
Secondary outcome [4] 402789 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 [4] 402789 0
Baseline, 4 weeks post-intervention (6 weeks after baseline assessment for care as usual families), and 3 month follow-up.
Secondary outcome [5] 403546 0
Treatment Adherence: Use of topical eczema medications (corticosteroids), assessed using the Medication Event Monitoring System (MEMS) 6 TrackCaps.
Timepoint [5] 403546 0
Daily adherence to topical corticosteroids, the need for which will be assessed via weekly clinical photographs of child child's most severe patch of eczema, will be monitored for the duration of participation in the study, beginning 1 month prior to randomisation and continuing until 3-month follow-up.

Eligibility
Key inclusion criteria
Parents of 2- to 10-year-old children with eczema who are currently prescribed topical corticosteroids
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Child has a disability, including language and speech impairment.
Parents are currently seeing a professional for the child’s behaviour difficulties.
Parents are currently receiving psychological help or counselling.
The parents have previously completed Triple P.
The parents unable to read at a fifth-grade reading level.

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
Intent-to-treat (ITT) analyses using repeated-measures hierarchical linear regression models (multilevel modelling) will compare change over time between groups on primary and secondary outcomes. Time is the main predictor and group membership is the main moderator. Dummy codes contrasting the groups will serve as fixed effects allowing for random intercepts and slopes across participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/12/2021
Actual
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
31/08/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 21063 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 35911 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 310112 0
Charities/Societies/Foundations
Name [1] 310112 0
Children's Hospital Foundation
Country [1] 310112 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] 311177 0
Individual
Name [1] 311177 0
A/Prof Alina Morawska (Co-Investigator)
Address [1] 311177 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
Country [1] 311177 0
Australia
Secondary sponsor category [2] 311180 0
Individual
Name [2] 311180 0
Ms Emily Casey (Co-Investigator)
Address [2] 311180 0
Department of Dermatology
Lady Cilento Children's Hospital
501 Stanley Street
South Brisbane QLD 4101
Country [2] 311180 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309800 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309800 0
Ethics committee country [1] 309800 0
Australia
Date submitted for ethics approval [1] 309800 0
01/03/2021
Approval date [1] 309800 0
24/03/2021
Ethics approval number [1] 309800 0
HREC/21/QCHQ/73923
Ethics committee name [2] 309803 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 309803 0
Ethics committee country [2] 309803 0
Australia
Date submitted for ethics approval [2] 309803 0
13/05/2021
Approval date [2] 309803 0
14/05/2021
Ethics approval number [2] 309803 0
2021/HE000945
Ethics committee name [3] 309804 0
Griffith University Human Research Ethics Committee
Ethics committee address [3] 309804 0
Ethics committee country [3] 309804 0
Australia
Date submitted for ethics approval [3] 309804 0
05/05/2021
Approval date [3] 309804 0
19/05/2021
Ethics approval number [3] 309804 0
2021/311

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

Contacts
Principal investigator
Name 115434 0
Dr Amy Mitchell
Address 115434 0
Menzies Health Institute Queensland, Griffith University, Nathan Campus, Kessels Road, Nathan QLD 4111
Country 115434 0
Australia
Phone 115434 0
+61 7 3735 6462
Fax 115434 0
Email 115434 0
amy.mitchell@griffith.edu.au
Contact person for public queries
Name 115435 0
Amy Mitchell
Address 115435 0
Menzies Health Institute Queensland, Griffith University, Nathan Campus, Kessels Road, Nathan QLD 4111
Country 115435 0
Australia
Phone 115435 0
+61 7 3735 6462
Fax 115435 0
Email 115435 0
amy.mitchell@griffith.edu.au
Contact person for scientific queries
Name 115436 0
Amy Mitchell
Address 115436 0
Menzies Health Institute Queensland, Griffith University, Nathan Campus, Kessels Road, Nathan QLD 4111
Country 115436 0
Australia
Phone 115436 0
+61 7 3735 6462
Fax 115436 0
Email 115436 0
amy.mitchell@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data, after removal of sensitive variables from the data set.
When will data be available (start and end dates)?
Following publication of trial results; no end date determined.
Available to whom?
Data will be made available to researchers only on the condition of approval from the original research team.
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.
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 (please contact Dr Amy Mitchell, amy.mitchell@griffith.edu.au).


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.