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Trial registered on ANZCTR


Registration number
ACTRN12609000710224
Ethics application status
Approved
Date submitted
12/08/2009
Date registered
17/08/2009
Date last updated
17/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reducing Externalising Behaviour Problems in Children with Type 1 Diabetes: A Controlled Evaluation of the Triple P-Positive Parenting Program.
Scientific title
Children with Type 1 Diabetes: evaluating the Triple P Positive Parenting Program compared to Standard Diabetes Care for reducing externalising behaviour problems.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes and externalising behaviour problems 243501 0
Condition category
Condition code
Metabolic and Endocrine 239801 239801 0 0
Diabetes
Mental Health 239826 239826 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Triple P Positive Parenting Intervention: Following Sanders (1999), parents randomly assigned to this condition will be taught 17 core child management strategies. Ten of the strategies are designed to promote children’s competence and development (i.e., quality time; talking with children; physical affection; praise; attention; engaging activities; setting a good example; ‘Ask’, ‘Say Do’; incidental teaching; and behaviour charts), and 7 strategies are designed to help parents manage misbehaviour (i.e., setting rules; directed discussion; planned ignoring; clear, direct instructions; logical consequences; quiet time; and time out). Parents will further be taught a six-step planned activities routine to enhance the generalization and maintenance of parenting skills (i.e., plan ahead, decide on rules, select engaging activities, decide on rewards and consequences, and hold a follow-up discussion with child). Each family will receive *Every Parent (Sanders, 1992) and a workbook, *Every Parent’s Family Workbook (Markie-Dadds, Sanders, & Turner, 2001). Parents will also receive active skills training and support from a trained practitioner (Liz Westrupp) as described by Sanders and Dadds (1993). Active skills training methods will include modelling, role-plays, feedback, and the use of specific homework tasks. On average, parents will attend approximately 10 individual appointments with the practitioner and complete approximately 10 hours of intervention in this condition.
Intervention code [1] 237117 0
Behaviour
Comparator / control treatment
Standard Diabetes Care: Parents randomly assigned to this condition will receive routine clinical care from the diabetes team over the 15-month study period. As well as medical management, this includes support from a dedicated dietician, a diabetes nurse educator and a social worker
Control group
Active

Outcomes
Primary outcome [1] 240568 0
Behavior Assessment System for Children, Second Edition (BASC-2; Reynolds & Kamphaus, 1992, parent-report version). The BASC-2 is a multi-method, multi-dimensional system that evaluates the behaviour of children aged 4-18 years. The present study will use only the Parent Rating Scale (PRS) of the BASC-2 (to be completed by the participant?s parent), which provides a comprehensive measure of a child?s adaptive and problem behaviours in community and home settings. The PRS contains descriptors of behaviours that the respondent rates on a four-point scale of frequency, ranging from never to almost always. The PRS assesses clinical problems in the broad domains of Externalising Problems and Internalising Problems and it also measures Adaptive Skills. A T-score of > 60 on either of the scales indicates the presence of substantial problems. The BASC-2 has excellent norms based on a large sample of the general population, representative with regard to gender, race, ethnicity, clinical classification and parent education. Internal consistency reliabilities are in the middle 0.80s to low 0.90s for all composite scores. Evidence of validity is supported via factor structure analyses and comparison to the Achenbach Child Behaviour Checklist, showing strong, significant correlations with relevant composites (Reynolds & Kamphous, 1992).
Timepoint [1] 240568 0
(1) at time of recruitment for both groups;
(2) at the completion of treatment for the intervention group (approximately 10-12 weeks) and at 12 weeks post-recruitment for the control group;
(3) at 6 months post-treatment for the intervention group and 6 months post (initial) follow-up for the control group;
(4) at 12 months post-treatment for the intervention group and 12 months post (initial) follow-up for the control group.
Secondary outcome [1] 257180 0
Measure of Glycemic Control. Blood sampling to assess glycaemic control (HbA1c levels) routinely occurs at each three-monthly diabetic clinic visit. With consent, this information will be accessed from the diabetes unit database. In addition, an average of each child?s Total Daily Insulin Dose will be calculated for the treatment period (units of insulin per kilo of body weight, per day). No additional blood samples are required for study purposes.
Timepoint [1] 257180 0
(1) at time of recruitment for both groups;
(2) at the completion of treatment for the intervention group (approximately 10-12 weeks) and at 12 weeks post-recruitment for the control group;
(3) at 6 months post-treatment for the intervention group and 6 months post (initial) follow-up for the control group;
(4) at 12 months post-treatment for the intervention group and 12 months post (initial) follow-up for the control group.

Eligibility
Key inclusion criteria
1.Children with diagnosed Type 1 Diabetes (of a minimum of 6 months duration) who attend the Diabetes Clinic at the Royal Children's Hospital Melbourne (RCH).

2.Children with clinically significant emotional problems and/or behaviour problems (i.e., Internalising T Score > 60 or Externalising T score > 60) will be eligible to participate and will be allocated on the basis of their Externalising or Internalising behaviour problem T score.

3.Children without clinically significant emotional or behaviour problems (i.e., (i.e., Internalising T Score < 60 + Externalising T score < 60).
Minimum age
4 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1.Children whose mothers exhibit significant psychopathology (cut-off score of 12 for depression; Nieuwenhuijsen, de Boer, Verbeek, Blonk, & van Dijk, 2003) will not be invited to participate further in this study as previous research has shown that the Triple P intervention is less effective when mothers have untreated mental health problems. Children and mothers excluded on this basis will be offered assistance getting appropriate clinical services should they want them.

2.Children who commence or significantly modify psychotropic medication regimes (which may affect behaviour) during the research and follow-up periods. These children will continue to receive the Triple P Intervention or Standard Diabetes Care (SDC) but their data will not be included in analysis.

3.Children with a developmental disorder (such as Autism Spectrum Disorder) and children currently attending at a Special Education School or who qualify for Integration Aide Assistance. These children represent a special population for which individually tailored programs are required.

4.Other exclusion criteria for the study include the following:
?non-English speaking families;
?children with complex medical disease in addition to Type 1 diabetes (e.g., cystic fibrosis, cancer, Traumatic Brain Injury).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A system of random numbers was used to generate a slip of paper with the following: assigned study ID number, stratum and study condition. Each slip was then sealed within an envelope. A total of 80 envelopes were divided into two sets of 40, with the stratum printed on the outside: (1) clinical behaviour problems present; (2) no behaviour problems. For every new participant recruited, the appropriate envelope was opened according to pre-intervention BASC-2 results, and the information on the slip contained within the envelope allocated the participant to the intervention or comparision group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sample will be divided into children with clinically significant behaviour or emotional problems (BASC-2 externalising/ internalising T score > 60) and a second group of children with no/few behaviour problems (BASC-2 externalising/ internalising T score <60). Participants will be randomly allocated (using a system of random numbers) into a treatment or a comparison arm of the study, this randomisation will be stratified by behavioural problems or not. Comparison participants in each group will receive Standard Diabetes Care (SDC) through the Diabetes unit. Treatment participants within each group will receive the Triple P Intervention in addition to SDC.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)

Funding & Sponsors
Funding source category [1] 237490 0
Charities/Societies/Foundations
Name [1] 237490 0
Murdoch Children?s Research Institute
Address [1] 237490 0
Murdoch Children?s Research Institute
Flemington Road
Parkville
Melbourne, VIC 3052
Country [1] 237490 0
Australia
Funding source category [2] 237491 0
Commercial sector/Industry
Name [2] 237491 0
Eli Lilly and Company
Address [2] 237491 0
Eli Lilly Australia
112 Wharf Road
West Ryde NSW 2114
Country [2] 237491 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children’s Research Institute
Address
Murdoch Children?s Research Institute
Flemington Road
Parkville
Melbourne, VIC 3052
Country
Australia
Secondary sponsor category [1] 236972 0
Hospital
Name [1] 236972 0
The Royal Children's Hospital
Address [1] 236972 0
The Royal Children's Hospital
Flemington Road
Parkville
Melbourne, VIC 3052
Country [1] 236972 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239612 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 239612 0
Royal Children's Hospital
Flemington Road
Parkville
Melbourne, VIC 3052
Ethics committee country [1] 239612 0
Australia
Date submitted for ethics approval [1] 239612 0
Approval date [1] 239612 0
25/06/2008
Ethics approval number [1] 239612 0
HREC 28026

Summary
Brief summary
The purpose of this project is to test the usefulness of a parenting program in reducing and/or preventing behaviour problems and improving metabolic control in children who have developed diabetes in the past couple of years. If the program is helpful, we hope that this will improve the emotional and physical wellbeing of these children in the future.
Previous research has shown that children who have behaviour problems before, or soon after they develop diabetes, are at an increased risk for ongoing emotional difficulties, as well as being more likely to have poorly controlled diabetes. We plan to invite the families of children who have diabetes and behaviour problems to take part in this project. Half of these families will be offered a parenting program and the other half will receive the standard care from the Diabetes Clinic.

We are also interested in finding out whether this parenting program may prevent behaviour problems developing in the future. We also plan to invite families of children who have diabetes and do not have behaviour problems to take part. Half the families will take part in the parenting program and half will receive the standard care. This will allow us to see whether the parenting program can prevent the development of behaviour problems in children who do not have problems at the moment. We are hoping 80 families will take part in this project.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30043 0
Address 30043 0
Country 30043 0
Phone 30043 0
Fax 30043 0
Email 30043 0
Contact person for public queries
Name 13290 0
A/Prof Fergus Cameron
Address 13290 0
Department of Endocrinology and Diabetes
The Royal Children's Hospital
Flemington Road
Parkville
Melbourne, VIC 3052
Country 13290 0
Australia
Phone 13290 0
+61 3 9345 6972
Fax 13290 0
Email 13290 0
fergus.cameron@rch.org.au
Contact person for scientific queries
Name 4218 0
A/Prof Elisabeth Northam
Address 4218 0
Psychology Department
The Royal Children's Hospital
Flemington Road
Parkville
Melbourne, VIC 3052
Country 4218 0
Australia
Phone 4218 0
+61 3 9345 6523
Fax 4218 0
Email 4218 0
lis.northam@rch.org.au

No information has been provided regarding IPD availability
Summary results
No Results