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Trial registered on ANZCTR


Registration number
ACTRN12613001281785
Ethics application status
Approved
Date submitted
19/11/2013
Date registered
20/11/2013
Date last updated
6/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the Positive Parenting Program (Triple P) for parents of young children with type 1 diabetes
Scientific title
Efficacy of the Positive Parenting Program (Triple P) for parents of children with type 1 diabetes in improving parenting skills and confidence relating to general child behaviour and illness management
Secondary ID [1] 283590 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes (Illness severity/ control) 290503 0
Parenting practices/ behaviour 290504 0
Child behaviour and adjustment 290505 0
Parent adjustment and stress 290506 0
Child illness behaviour 290507 0
Parenting efficacy 290508 0
Child's quality of life 290509 0
Family quality of life 290510 0
Condition category
Condition code
Mental Health 290895 290895 0 0
Studies of normal psychology, cognitive function and behaviour
Metabolic and Endocrine 290897 290897 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of two, 2-hour group discussion sessions, Positive Parenting for Healthy Living, designed to target the direct and indirect pathways of parenting impact on child outcomes i.e. parenting practices, and parenting confidence and stress. The content of the sessions draws on the theoretical principles that form the basis of Triple P, and is designed to be interactive and provide opportunities for discussion.

The first session focuses on providing parents with strategies that empower them to prevent and manage problem behaviours and ensure their children are implementing their illness prevention and management plan appropriately (e.g. monitoring their condition appropriately, taking medication as prescribed). The second session is designed as an introduction to the principles of positive parenting in the context of child chronic illness management, to promote positive parenting practices, assist parents to develop effective disciplinary methods, and help create environments conducive to caring relationships between parents and their children. It begins with a discussion of why children with diabetes may be at risk of behaviour problems, before examining common parenting traps from the perspective of parenting a child with diabetes, followed by assertive discipline strategies.

Parents are encouraged to take their child to regular, ongoing visits with their usual diabetes team.
Intervention code [1] 288277 0
Behaviour
Comparator / control treatment
Families in the control group (Care As Usual) will be assessed on entry to the trial, 6 weeks later, and then again at 6 months. During this time, families will continue to receive regular medical management from their usual diabetes team, as appropriate. After the 6-month follow-up assessment families will be offered participation in the intervention.
Control group
Active

Outcomes
Primary outcome [1] 290879 0
Parenting behaviour as measured by The Alabama Parenting Questionnaire-Parent and Child Report
Timepoint [1] 290879 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Primary outcome [2] 290880 0
Child behaviour and adjustment as measured by Child Adjustment and Parent Efficacy Scale (Morawska & Sanders, 2010)
Timepoint [2] 290880 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Primary outcome [3] 290881 0
Child's quality of life measured by PedsQL4.0 Generic Core Scale (Varni, Seid, & Kurtin, 2001)
Timepoint [3] 290881 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [1] 305529 0
Illness severity/ control indicated by HbA1c levels and blood glucose reading downloads
Timepoint [1] 305529 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [2] 305530 0
Parenting efficacy and confidence in diabetes management measured by Self-Efficacy for Diabetes Scale (Streisand, Swift, Wickmark, Chen, & Holmes, 2005)
Timepoint [2] 305530 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [3] 305531 0
Child illness behaviour assessed by scores on Diabetes Behaviour Checklist (Morawska, Mitchell & Pay, 2012)
Timepoint [3] 305531 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [4] 305532 0
Family quality of life assessed using PedsQL Family Impact Module (Varni, Sherman, Burwinkle, Dickinson, & Dixon, 2004)
Timepoint [4] 305532 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [5] 305533 0
Illness-specific and general parenting stress, measured by Parenting Stress Index-Short Form (PSI/SF; Abidin, 1990) and Parent Experience of Child Illness Scale (Bonner, Hardy & Guill, 2006)
Timepoint [5] 305533 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [6] 305534 0
Child and parent behaviour through home observations, Family Observation Schedule (Sanders, Dadds & Bor, 1989) and Mealtime Observation Schedule (Sanders, Le Grice &Turner, 1993)
Timepoint [6] 305534 0
Baseline, 4 weeks post-intervention, 6 months after intervention
Secondary outcome [7] 305535 0
Parent's satisfaction with the program assessed through Client Satisfaction Questionnaire (Turner, Markie-Dadds, & Sanders, 1998)
Timepoint [7] 305535 0
Immediately post-intervention
Secondary outcome [8] 306177 0
Child's satisfaction with the program to be assessed by Child Satisfaction Questionnaire (Sofronoff & Morawska, 2006).
Timepoint [8] 306177 0
Immediately post-intervention

Eligibility
Key inclusion criteria
The key inclusion criteria is:

(i) presence in the family of a 2-10 year old child;

(ii) child has diagnosis of type 1 diabetes
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria include: (i) child has a disability including language and speech impairment; (ii) parents are currently seeing a professional for the child’s behaviour difficulties; (iii) parents are currently receiving psychological help or counselling; (iv) parents have difficulties in reading a newspaper or (v) the child has been diagnosed in the last three months

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)
A pre-prepared series of sealed opaque envelopes, each labelled with a participant ID number and containing a Randomisation Notification Letter, will be used to conceal the group allocation from both researchers and participants until after completion of the time 1 assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of participants to either the intervention group or the waitlist control group 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
The updated sample size for the study was calculated to assure 80% power to detect an effect size of .5 for a mean difference in rates of change in the variables of interest between the groups. The power analyses conducted using G Power software indicated that a sample size of 50 is sufficient to detect an ES of .5 at the significance level of .05 (two-tailed). Assuming 16% attrition rate, an available sample of 60 families will be sufficient to detect medium sized effects.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3701 0
Lady Cilento Children's Hospital - South Brisbane

Funding & Sponsors
Funding source category [1] 288270 0
Government body
Name [1] 288270 0
Australian Research Council
Address [1] 288270 0
GPO Box 2702
CANBERRA
ACT 2601
AUSTRALIA
Country [1] 288270 0
Australia
Primary sponsor type
Individual
Name
Alina Morawska
Address
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 286985 0
Individual
Name [1] 286985 0
Kate Sofronoff
Address [1] 286985 0
School of Psychology
The University of Queensland
St Lucia QLD 4072
Country [1] 286985 0
Australia
Secondary sponsor category [2] 286986 0
Individual
Name [2] 286986 0
Jennifer Batch
Address [2] 286986 0
Lady Cilento Children's Hospital, South Brisbane QLD 4101
Country [2] 286986 0
Australia
Secondary sponsor category [3] 287196 0
Individual
Name [3] 287196 0
Ania Filus
Address [3] 287196 0
Parenting and Family Support Centre
School of Psychology Social Sciences Building (Blg 24)
The University of Queensland
St Lucia QLD 4072
Country [3] 287196 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290168 0
UQ Behavioural & Social Sciences Ethical Review Committee (BSSERC)
Ethics committee address [1] 290168 0
UQ Research & Innovation
Cumbrae-Stewart Building (72)
The University of Queensland
St Lucia
QLD 4072
Ethics committee country [1] 290168 0
Australia
Date submitted for ethics approval [1] 290168 0
17/10/2013
Approval date [1] 290168 0
19/11/2013
Ethics approval number [1] 290168 0
2013001357

Summary
Brief summary
Type 1 diabetes is a serious condition affecting thousands of Australian children. It can lead to severe consequences for children including negative health outcomes, and elevated rates of behavioural and emotional problems, which can persist into adulthood. Parents of children with diabetes experience considerable difficulties, lack confidence, are unsure about what is appropriate for their child, and struggle with incorporating tasks into their day-to-day routines. This study aims to evaluate the efficacy of a brief, group-based parenting intervention for parents of children with type 1 diabetes. It is expected that participating in a group based parenting intervention has the potential to reduce ineffective and coercive parenting practices, and lead to improved child behavioural and emotional adjustment, better family wellbeing, and healthier children.
Trial website
None.
Trial related presentations / publications
Lohan, A., Mitchell, A.E., Filus, A., Sofronoff, K., & Morawska, A. (2016). Positive parenting for healthy living (Triple P) for parents of children with type 1 diabetes: protocol of a randomised controlled trial. BMC Pediatrics, 16 (158).
Public notes

Contacts
Principal investigator
Name 44306 0
Dr Alina Morawska
Address 44306 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
Country 44306 0
Australia
Phone 44306 0
+61 7 3365 7304
Fax 44306 0
Email 44306 0
alina@psy.uq.edu.au
Contact person for public queries
Name 44307 0
Dr Alina Morawska
Address 44307 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
Country 44307 0
Australia
Phone 44307 0
+61 7 3365 7304
Fax 44307 0
Email 44307 0
alina@psy.uq.edu.au
Contact person for scientific queries
Name 44308 0
Dr Alina Morawska
Address 44308 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia QLD 4072
Country 44308 0
Australia
Phone 44308 0
+61 7 3365 7304
Fax 44308 0
Email 44308 0
alina@psy.uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary