Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000368336
Ethics application status
Approved
Date submitted
20/06/2008
Date registered
30/07/2008
Date last updated
13/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Health and coping in type 1 diabetes: The effects of a psycho-educational program to improve metabolic control in adolescents with type 1 diabetes
Scientific title
Health and coping in type 1 diabetes: The effects of a psycho-educational program to improve metabolic control in adolescents with type 1 diabetes
Secondary ID [1] 609 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 3289 0
Condition category
Condition code
Metabolic and Endocrine 3451 3451 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is based on The Best of Coping (Frydenberg & Brandon, 2007), a coping skills training program developed for adolescents. The current intervention will be an adapted 'diabetes-specific' version of The Best of Coping (BOC). The BOC program teaches productive coping skills using a cognitive-behavioural framework. The modules in the BOC program cover aspects such as learning about productive and non-productive coping, problem-solving, thinking optimistically, goal-setting, time-management, and effective communication.The program employs an interactive approach to learning using role-play, modelling and constructive feedback. The current intervention will involve five weekly sessions lasting for two hours.
Intervention code [1] 3026 0
Behaviour
Comparator / control treatment
The control group will continue to receive standard care at the Diabetes Clinic which includes support from a diabetes team including doctors, a dietician, a diabetes nurse and a social worker.
Control group
Active

Outcomes
Primary outcome [1] 4347 0
Improved metabolic control (lower glycosylated hemoglobin / HbA1c levels assessed at the Royal Children's Hospital as part of standard care)
Timepoint [1] 4347 0
Baseline, and 3 and 12-months post-intervention
Secondary outcome [1] 7573 0
1. Increase in productive coping: assessed by the Adolescent Coping Scale (Long Form, Specific) (Frydenberg & Lewis, 1993)
Timepoint [1] 7573 0
Baseline, and 3 and 12-months post-intervention
Secondary outcome [2] 7574 0
2. Improvement in diabetes regimen adherence: assessed by the Diabetes Behaviour Rating Scale (Adolescent Version) (Iannotti et al., 2006)
Timepoint [2] 7574 0
Baseline, and 3 and 12-months post-intervention
Secondary outcome [3] 7575 0
3. Improved self-efficacy: assessed by the Self-Efficacy for Diabetes Scale (Grossman, Brink, & Hauser, 1987)
Timepoint [3] 7575 0
Baseline, and 3 and 12-months post-intervention
Secondary outcome [4] 7576 0
4. Improved quality of life: assessed by the Diabetes Quality of Life for Youth scale (Ingersoll & Marrero, 1991)
Timepoint [4] 7576 0
Baseline, and 3 and 12-months post-intervention

Eligibility
Key inclusion criteria
(1) aged 13-16 years, (2) diagnosed with type 1 diabetes more than one year ago, (3) currently attending secondary school
Minimum age
13 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) non-English speaking adolescents, (2) adolescents who have thyroid disease or any other significant health conditions in addition to diabetes, (3) children with developmental disorders (e.g. 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.

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)
Participants will be informed about the study by the principal investigator, who will make it clear that their treating physician will not be informed of whether they decide to participate or not. The principal investigator will give the participants the Plain Language Statement and Consent Forms (with a pre-paid envelope). In order to ensure that allocation to the two treatment groups is random and concealed during participant recruitment, this study will use the sealed envelope protocol. The Clinical Epidemiology and Biostatistics Unit (CEBU) at the Royal Children's Hospital (RCH) will provide an appropriate number of sealed envelopes with randomly appointed treatment allocations. Once the principal investigator receives a participant’s Consent Form she will open one envelope and that participant will be allocated to that specific treatment group. This protocol will be repeated for all the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-based random number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2008
Actual
7/07/2009
Date of last participant enrolment
Anticipated
Actual
31/08/2010
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
156
Accrual to date
Final
156
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 3499 0
Hospital
Name [1] 3499 0
The Royal Children's Hospital
Country [1] 3499 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne, Carlton Victoria 3010
Country
Australia
Secondary sponsor category [1] 3142 0
None
Name [1] 3142 0
Address [1] 3142 0
Country [1] 3142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5537 0
Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 5537 0
Royal Children's Hospital
Ethics and Research
Flemington Road, Parkville
Victoria, 3052
Ethics committee country [1] 5537 0
Australia
Date submitted for ethics approval [1] 5537 0
20/06/2008
Approval date [1] 5537 0
27/10/2008
Ethics approval number [1] 5537 0
HREC 28080 A

Summary
Brief summary
Successful management of type 1 diabetes includes adhering to a complex and often intrusive treatment regimen, which can be especially challenging and stressful for young people. This study aims to adapt and trial a coping skills training program The Best of Coping (Frydenberg & Brandon, 2007) and to assess the program’s efficacy in improving glycaemic control, coping skills, diabetes-specific self-efficacy (confidence in one’s own ability to manage with diabetes), diabetes regimen adherence, and quality of life in adolescents aged 13-16 years with type 1 diabetes. Hypothesis: It is predicted that the BOC program will improve glycaemic control at the 3 and 12 month follow-up compared to the control group. Hypothesis 2: It is predicted that the BOC program will improve productive coping skills, self-efficacy, adherence to the diabetes treatment regimen, stress levels and quality of life compared to the control group at 3 and 12 months after baseline.
Trial website
Trial related presentations / publications
Serlachius, A., Scratch, S., Northam, E., Frydenberg, E., Lee, K., Cameron, F. (2014). A randomized controlled trial of cognitive behaviour therapy to improve glycaemic control and psychosocial wellbeing in adolescents with type 1 diabetes. Journal of Health Psychology, 1359105314547940. [Epub ahead of print]
Public notes

Contacts
Principal investigator
Name 28683 0
A/Prof Lis Northam
Address 28683 0
Royal Children's Hospital
Flemington Road
Victoria
Country 28683 0
Australia
Phone 28683 0
+61 03 9345 7057
Fax 28683 0
Email 28683 0
[email protected]
Contact person for public queries
Name 11840 0
Dr Ms Anna Serlachius
Address 11840 0
Royal Children's Hospital
Flemington Road, Parkville, VIC, 3052
Country 11840 0
Australia
Phone 11840 0
(03) 9345 6773
Fax 11840 0
Email 11840 0
[email protected]
Contact person for scientific queries
Name 2768 0
A/Prof A/Prof Elisabeth Northam
Address 2768 0
Royal Children's Hospital
Flemington Road, Parkville, VIC, 3052
Country 2768 0
Australia
Phone 2768 0
(03) 9345 6523
Fax 2768 0
Email 2768 0
[email protected]

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

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