Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000457448
Ethics application status
Not yet submitted
Date submitted
30/08/2007
Date registered
11/09/2007
Date last updated
30/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The “You Beat-It” lifestyle program targeting mental health issues for adolescents with diabetes.
Scientific title
A randomised clinical control trial utilising a group treatment Program for the Psychological Difficulties Associated with Adolescent Diabetes (Type 1)
Universal Trial Number (UTN)
Trial acronym
The "You-Beat It" program
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adolescent Mental Health. 2311 0
Adolescent Diabetes self management. 2339 0
Condition category
Condition code
Mental Health 2412 2412 0 0
Depression
Metabolic and Endocrine 2427 2427 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study involves an adolescent group Psychological intervention using an Interpersonal Psychotherapy approach.
Participants will be adolescent with diabetes aged 13-17 yrs and meet for two hours each week over a 10 week period to complete the “You Beat-It” program.
The purpose of the program is to help adolescent address the psychological problems associated with their diabetes.
Treatment will follow an Interpersonal Psychotherapy (IPT) approach which was originally designed for the treatment of adult depression.
IPT attempts to bring about change in interpersonal relationships by simplifying them into four core problem areas (Interpersonal Disputes, Role Transitions, interpersonal Sensitivity and Loss-Grief). In providing a simplified means of understanding these problems, it provides alternative pathways to resolve Interpersonal difficulties.Specific strategies are then used to aide in these 4 core problem areas (assertiveness, problem solving, role plays etc).
Intervention code [1] 2033 0
Behaviour
Intervention code [2] 2059 0
Lifestyle
Comparator / control treatment
Wait list control group.
Control group
Active

Outcomes
Primary outcome [1] 3311 0
Percentage change in adolescent self report on mental health measures ie Child Behaviour Checklist-youth report, Child Depresion Inventory, Diabetes Quality of life Questionaire.
Timepoint [1] 3311 0
Pretreatment and 3 months post treatment
Secondary outcome [1] 5561 0
Clinical and statistical significant changes in adolescent reports of quality of life, general health, diabeates knowledge, mood.
Timepoint [1] 5561 0
Pretreatment and 3 months post treatment.

Eligibility
Key inclusion criteria
Teenagers as participants aged-between 13-17 and having diabetes.
Minimum age
13 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Significant mental health problems i.e. active suicidality, psychosis or inappropriateness to go on waitlist due to severity of presenting problem etc.

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)
Random allocation to either treatment or waitlist control groups via central randomisation from computer. Chief invesigators/treatment group co-ordinators will be blind to participant allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Use of eton statistical tables will be used to generate random numbers which are then allocated to participant to determine which group they are allocated, i.e treatment v.s waitlist controls.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/01/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 260 0
4215

Funding & Sponsors
Funding source category [1] 2574 0
Self funded/Unfunded
Name [1] 2574 0
Queensland Health/Gold Coast Hospital
Country [1] 2574 0
Australia
Funding source category [2] 2598 0
Self funded/Unfunded
Name [2] 2598 0
Queensland Department Of Health
Country [2] 2598 0
Australia
Primary sponsor type
Government body
Name
Queensland Department of Health
Address
Department of Paediatrics
Gold Coast Hospital
108 Nerang Street
Southport Gold Coast QLD 4215
Country
Australia
Secondary sponsor category [1] 2326 0
None
Name [1] 2326 0
Address [1] 2326 0
Country [1] 2326 0
Secondary sponsor category [2] 2350 0
None
Name [2] 2350 0
Address [2] 2350 0
Country [2] 2350 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4493 0
Gold Coast Hospital HSD Ethics Committee
Ethics committee address [1] 4493 0
Gold Coast Hospital
108 Nerang Street
Southport Gold Coast QLD 4215
Ethics committee country [1] 4493 0
Australia
Date submitted for ethics approval [1] 4493 0
01/10/2007
Approval date [1] 4493 0
Ethics approval number [1] 4493 0
NA
Ethics committee name [2] 4517 0
Ethics committee address [2] 4517 0
Ethics committee country [2] 4517 0
Date submitted for ethics approval [2] 4517 0
23/09/2007
Approval date [2] 4517 0
Ethics approval number [2] 4517 0

Summary
Brief summary
This study takes the form of a repeated measures time series experimental design
with wait list controls.
Participants will be adolescent with diabetes aged 13-17 years and meet for two hours each week over a 8 week period to complete the “You Beat-It” program. Participants will be randomly assigned to either treatment or waitlist control groups and will be self referred from the Gold Coast Hospital or via private medical services.
The purpose of the program is to help adolescent address the psychological problems associated with their diabetes. Consequently, it is hypothesised that if adolescent mental health improves so will their diabetic management.
Trial website
http://www.health.qld.gov.au/youbeatit
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28018 0
Address 28018 0
Country 28018 0
Phone 28018 0
Fax 28018 0
Email 28018 0
Contact person for public queries
Name 11175 0
Kim LeGros
Address 11175 0
Department of Paediatrics
Gold Coast Hospital
108 Nerang St
Southport Gold Coast QLD 4215
Country 11175 0
Australia
Phone 11175 0
+61 7 55198861
Fax 11175 0
+61 7 55198211
Email 11175 0
[email protected]
Contact person for scientific queries
Name 2103 0
Kim LeGros
Address 2103 0
Department of Paediatrics
Gold Coast Hospital
108 Nerang St
Southport Gold Coast QLD 4215
Country 2103 0
Australia
Phone 2103 0
+61 7 55198861
Fax 2103 0
+61 7 55198211
Email 2103 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.