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Trial registered on ANZCTR


Registration number
ACTRN12614000678695
Ethics application status
Approved
Date submitted
13/06/2014
Date registered
26/06/2014
Date last updated
26/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of a group e-Parenting Intervention Targeting Behavioural Problems for Children with Leukaemia – A pilot study
Scientific title
Targeting Behavioural Problems for Children with Leukaemia: Feasibility of the group TripleP e-parenting intervention.
Secondary ID [1] 284694 0
None
Universal Trial Number (UTN)
U1111-1146-6083
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukaemia 292048 0
Child behavioural problems 292104 0
Child sleep problems 292105 0
Child diet 292106 0
Child emotional problems 292107 0
Condition category
Condition code
Cancer 292384 292384 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study aims to assess the feasibility of the Triple P Positive Parenting Program for parents who have a
child diagnosed with acute lymphoblastic leukaemia. Triple P is an evidence-based program developed specifically to provide parents with practical strategies for dealing with problem behaviour in their children.

Current research shows that parents of children being treated for childhood leukaemia have reported treatment related behavioural problems, including sleep, diet and general behaviour. Currently no evidence-based parenting interventions targeting these issues exist. The aim of the current study is pilot an existing evidence-based parenting intervention: Triple P - Positive Parenting Program (Group format for 0-12 year old children) using a live online meeting platform in order to: 1) assess the relevance of the intervention for paediatric cancer; 2) identify any modifications required to better tailor the program to the needs of parents of children with cancer; and 3) assess the feasibility of the live online delivery modality.

The intervention will be delivered in an online group format therefore providing accessible and equitable parenting
support for metropolitan, regional and rural families. The results from this pilot intervention will be used to inform the
development of a cancer-specific Triple P Intervention (CancerCare Triple P) for implementation across multiple
paediatric oncology sites nationally.

Participants will be randomly allocated to an intervention (N=12) or control (N=12) arm. Intervention group parents will participate in a 9-week live online (5 x 1 hr face-to face via iPads and 4 x 30minuts via phone) group-based parenting intervention, facilitated by a TripleP trained Psychologist. Both intervention and control groups will complete online surveys measuring parenting strategies, child sleep, child diet, child behaviour and other feasibility questionnaires at three timepoints (2 weeks prior to the first intervention, and again at 2 and 12 weeks post intervention).
Intervention code [1] 289483 0
Behaviour
Comparator / control treatment
The aim of the current study is to assess the efficacy of a live online parenting intervention, and therefore a waitlist control group, in which participants do not receive the intervention will be used.

Participants in this group, which is based on random allocation, will not receive the intervention at the commencement of the study, but will have the opportunity to access the intervention at the completion of all time points (i.e. after completion of Time 3 assessments (12 weeks post baseline)).
Control group
Active

Outcomes
Primary outcome [1] 292243 0
Child emotional and behavioural problems: % with a score 17 or more on the total difficulties scale of the Strength and Difficulties Questionnaire
Timepoint [1] 292243 0
Baseline, 2 and 12-weeks post intervention completion.
Primary outcome [2] 292300 0
Child Diet: % with score 14 or more on the fruit and vegetable sub scale of the Children's Dietary Questionnaire and % with a score of 2 or less on the non-core food sub-scale of the Children's Dietary Questionnaire.
Timepoint [2] 292300 0
Baseline, 2 and 12-weeks post intervention completion.
Primary outcome [3] 292301 0
Child Sleep: % with score 41 or more on the total sleep problems scale of the Children't Sleep Habits Questionnaire.
Timepoint [3] 292301 0
Baseline, 2 and 12-weeks post intervention completion.
Secondary outcome [1] 308524 0
Examine participant satisfaction and acceptability of the intervention: Mean score on the Abbreviated Acceptability Rating Profile (AARP) and the Client Satisfaction Questionnaire (CSQ).
Timepoint [1] 308524 0
2 weeks post-intervention completion
Secondary outcome [2] 308525 0
Examine whether participation in Triple P results in increases in effective parenting practices. Assess changes in parenting strategies using validated survey measures of parental laxness (measured using the Arnold Parenting Scale) , parental overprotection (measured using the Parenting Protection Scale), interpersonal conflict over child rearing (measured using the Parent Problem Checklist), feeding strategies (measured using the Parental Feeding Style Questionnaire) and sleep strategies (measured using the Children's Sleep Habits Questionnaire together with a scale devised by the research team).
Timepoint [2] 308525 0
Baseline, 2 and 12-weeks post intervention completion.
Secondary outcome [3] 308527 0
Identify any modifications to the Group Triple P that will be needed in order to develop a cancer-specific Triple P Module (i.e., CancerCare Triple P).
Timepoint [3] 308527 0
Focus group at week 9 of the intervention.

Eligibility
Key inclusion criteria
Participants will include English-speaking parents of a child who meets the following eligibility criteria:

a) Is aged 2-8 years at the point of recruitment;
b) Has been diagnosed with acute lymphoblastic leukaemia (ALL);
c) Is on the maintenance phase of treatment;
d) Has not relapsed and is not receiving palliative care;
e) Has no other significant and unrelated medical condition (e.g. Autism, Down Syndrome).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parents/Caregivers will also be excluded from participating if deemed by the clinical treating team that the family should not be approached and also if their child:

a) Is considered palliative;
b) Has a neurological condition or major developmental disorder ;
c) Does not reside with the parent at least part-time.

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)
Concealed Allocation: Randomisation via sealed envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation schedule created by a biostatistician (idependent from the Research Team) using computer software. Randomisation schedule is concealed in 24 individual envelopes to be opened (1 p/participant) after each participant is recruited.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample characteristics will be described together with caregiver report of each component’s acceptability, frequency of use and ease of use. Barriers to session attendance and uptake of specific intervention strategies will be presented. Changes (baseline-4 months) in child and family outcomes will be reported. Specific details associated with each study aim are provided below.
a) Examine participant satisfaction and acceptability of the intervention;
The CSQ and AARP are administered at T2 and T3 for intervention group participants. An examination of mean scores at each time point as well as mean change in scores (using paired-samples t-tests) will be examined.
b) Examine whether participation in Triple P shows promise for improvements in effective parenting practices;
Group differences in mean change scores (e.g. Time 1 minus baseline and time 2 minus baseline) in parenting practices (using independent samples t-test) will be examined.
c) Explore whether participation in Triple P shows promise for improvements in child behaviour (sleep, diet and internalising/externalising behaviour);
Group differences in mean change scores (e.g. Time 1 minus baseline and time 2 minus baseline) for child sleep, diet and internalising/externalising behaviour (using independent samples t-test) will be examined.
d) Identify any modifications to the Group Triple P that will be needed in order to modify and improve CancerCare Triple P.
Qualitative thematic analysis will be employed using the focus group data collected during session 9 of the intervention (intervention group only) to derive any main themes that were identified by participants regarding modifications/improvements to the program. Information from informal focus group discussions that include the intervention moderator and project investigators will also be used to identify any avenues for intervention improvement.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/07/2014
Actual
Date of last participant enrolment
Anticipated
23/10/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2554 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 8236 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 289356 0
Charities/Societies/Foundations
Name [1] 289356 0
Murdoch Childrens Research Institute
Country [1] 289356 0
Australia
Funding source category [2] 289357 0
Charities/Societies/Foundations
Name [2] 289357 0
Ponting Foundation
Country [2] 289357 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Childrens Research Institution
Address
50 Flemington Road Parkville Victoria 3052 Australia.
Country
Australia
Secondary sponsor category [1] 288042 0
University
Name [1] 288042 0
The University of Queensland
Address [1] 288042 0
The University of Queensland
Brisbane QLD 4072 Australia
Country [1] 288042 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291124 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 291124 0
Ethics committee country [1] 291124 0
Australia
Date submitted for ethics approval [1] 291124 0
03/02/2014
Approval date [1] 291124 0
17/04/2014
Ethics approval number [1] 291124 0
34005A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 68 68 0 0
/AnzctrAttachments/366441-34005A App Cert 17 4 14.pdf

Contacts
Principal investigator
Name 48822 0
Dr Lauren Williams
Address 48822 0
Social and Mental Health Aspects of Serious Illness,
Clinical Sciences
Murdoch Childrens Research Institute
The Royal Children’s Hospital
50 Flemington Road Parkville Victoria 3052 Australia.
Country 48822 0
Australia
Phone 48822 0
+61 3 99366024
Fax 48822 0
Email 48822 0
Lauren.Williams@mcri.edu.au
Contact person for public queries
Name 48823 0
Lauren Williams
Address 48823 0
Social and Mental Health Aspects of Serious Illness,
Clinical Sciences
Murdoch Childrens Research Institute
The Royal Children’s Hospital
50 Flemington Road Parkville Victoria 3052 Australia.
Country 48823 0
Australia
Phone 48823 0
+61 3 99366024
Fax 48823 0
Email 48823 0
Lauren.Williams@mcri.edu.au
Contact person for scientific queries
Name 48824 0
Lauren Williams
Address 48824 0
Social and Mental Health Aspects of Serious Illness,
Clinical Sciences
Murdoch Childrens Research Institute
The Royal Children’s Hospital
50 Flemington Road Parkville Victoria 3052 Australia.
Country 48824 0
Australia
Phone 48824 0
+61 3 99366024
Fax 48824 0
Email 48824 0
Lauren.Williams@mcri.edu.au

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
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