Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000170022
Ethics application status
Approved
Date submitted
17/02/2010
Date registered
22/02/2010
Date last updated
21/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of the Nothing Ventured Nothing Gained (NV-NG) adolescent and parent program to promote well being in adolescents with type 1 diabetes.
Scientific title
The efficacy of the Nothing Ventured Nothing Gained (NV-NG) online adolescent and parent mental health program for the prevention of depression, anxiety and other adverse mental health problems in geographically and socially isolated adolescents with Type 1 diabetes.
Secondary ID [1] 1428 0
None
Universal Trial Number (UTN)
Trial acronym
NV-NG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 256839 0
Depression 256840 0
Anxiety 256841 0
Condition category
Condition code
Metabolic and Endocrine 256990 256990 0 0
Diabetes
Mental Health 256991 256991 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
NV-NG is an online intervention which consists of two parallel programs - one for the adolescent and one for their parent. Both programs consist of a set of fully self-directed modules (sessions), six sessions for parents and five sessions for adolescents, to be completed online over a period of six weeks. Each session takes approximately 30-45 minutes to complete. The adolescent program uses a cognitive behavioural approach to encourage adolescents to develop strategies to manage the challenges of normal adolescent development, their disease demands, and the interface between the two. Sessions focus on increasing knowledge about the interface between adolescent development and diabetes; understanding and developing strategies to increase psychological wellbeing; building and maintaining relationships with friends and family; problem solving and managing conflict; health promoting behaviours and body image. The parenting program is designed to support parents to optimise the resilience and wellbeing of their adolescent children by strengthening family relationships. Key components of the program include: 1) increasing parents’ knowledge of diabetes and its associated effects on mental health, behaviour, body image, and transition to adult care; 2) parenting strategies, focusing on autonomy granting and limit setting, development of responsibility and monitoring, connecting, communication, problem solving and managing parent-adolescent conflict, and 3) parent support associated with self-care, grief/loss, responsibility for, and care, of other family members. The intervention is delivered wholly online in a self-directed format, therefore the same content is available to all participants, however the degree to which participants access all the content within program sessions varies. Dosage is estimated based on the percentage of available content that each participant accessed.
Intervention code [1] 256040 0
Prevention
Intervention code [2] 256058 0
Other interventions
Comparator / control treatment
The comparator group will consist of a wait list control, who will be given access to the intervention at the end of their waiting period (6 months after baseline measures)
Control group
Active

Outcomes
Primary outcome [1] 257876 0
Primary adolescent outcome: Improved adolescent wellbeing (as indicated by lower depression and anxiety and improved parent reportof chid wellbeing) compared to the wait/control group. These constructs will be measured through questionnaires, including the Revised Children's Manifest Anxiety Scale Short Form(RCMAS), and the Children's Depression Inventory (CDI). Furthermore, parents' perceptions of their childs wellbeing will also be measured by the Child Health Questionnaire.
Timepoint [1] 257876 0
The time points for data collection for both the the intervetnion group and the wait list control group are T=0 (Baseline), T=6 weeks, and T=6 months. Of note, the wait list control group will be offered the intervention at a later date, however, their data will not be used in the study.
Primary outcome [2] 257877 0
Primary Parent Outcome: Improved parent wellbeing as measured by reduced negative affect, increased self efficacy and reduced fatigue compared to the wait/control group. Questionnaires will be used to assess these constructs. To assess parent self-efficacy, the Parenting Sense of Competence Scale will be used, while negative affect will be assessed via the Depression, Anxiety and Stress Scale (DASS 21), and parent fatigue will be measured through the Fatigue Assessment Scale (FAS).
Timepoint [2] 257877 0
The time points for data collection for both groups are T=0 (Baseline), T=6 weeks, and T=6 months.
Secondary outcome [1] 263332 0
Secondary adolescent outcome: Improved (lower) glycylated haemoglobin (HbA1c) measures (objective measure of diabetes control). HbA1c is assessed via a blood test that forms part of the child's routine clinic visits.
Timepoint [1] 263332 0
HbA1c results for adolescents will be reported by their endocrinologist at T=-3months (retrospectively), T=0 (baseline); T= 3months; and T= 6 months for both the intervention and wiatlist control groups.
Secondary outcome [2] 263333 0
Secondary Adolescent outcome: Improved diabetes relevant self care. This will be assessed via questionnaires. These willl include the Diabetes Self Care Inventory (SCI-R) and the Stanford Diabetes Self-Efficacy Scale.
Timepoint [2] 263333 0
The time points for data collection for both groups are T=0 (Baseline), T=6 weeks, and T=6 months.
Secondary outcome [3] 263334 0
Improved parent child relationship. The parent-child relationship will be assessed through several questionnaires. From the child's perspective, this will include the Parent- Adolescent Communication Scale, the family sharing of responsibility for diabetes care, and the Diabetes Conflict Scale.
To assess the parent's perspective, questionnaires assessing family sharing or responsibility for diabetes care and communication, as measured by the the Parent- Adolescent Communication Scale - parent report form, will be used.
Timepoint [3] 263334 0
The time points for data collection for both groups are T=0 (Baseline), T=6 weeks, and T=6 months.

Eligibility
Key inclusion criteria
To participate in the evaluation of the NV-NG intervention, participants need to meet the following criteria: - Adolescents to be aged from 13 to 18 years (no limitations on parents’ ages) and have Type 1 diabetes. - Be active patients at The Royal Children’s Hospital Diabetes Clinic or the Monash Medical Centre, Victoria Australia, and willing to sign consent for their endocrinologist to release their HBA1c results at pre-test (t=-3months & t=0), 3, and 6 month follow-up. These HbA1c tests are performed as part of their routine care at each clinic visit and therefore will not involve any additional testing. - Have internet access. - Own an email address and be able to use a password (provided to them) to register online. - Be able to speak and read English. - Be willing (and available) to take part in the program over a six-week period (or to wait 6 months for the intervention if in the waitlist control group). - Be willing to complete the pre-test and a further three sets of surveys (immediately post intervention/wait; and at 6 months post-intervention follow-up).
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the child with diabetes is not within the age range (13 to 18) or if the parent and child do not speak and read English they will not be eligable to participate in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A rolling recruitment strategy will be applied. Adolescents with Type 1 diabetes will be recruited through The Royal Children’s Hospital Diabetes Outreach service as well as Monash Medical Centre. Adolescents will be given an Information Statement and Consent Form at their regular clinic visit and asked to return consent forms (adolescent & parent) to the researchers if they wish to participate. Upon receipt of the consent forms the researcher will email them a computer login. When the families register online, the computer will automatically randomly allocate them to either the intervention or wait list control group. Thus, allocation to the different groups is concealed through the use of central randomisation by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation of participants to the intervention or waitlist groups will occur randomly using a computer random number generator during the registration process, which will be based on date and time of registration.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2010
Actual
11/10/2010
Date of last participant enrolment
Anticipated
Actual
19/10/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 2127 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 2128 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 7812 0
3052 - Parkville
Recruitment postcode(s) [2] 7813 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 256541 0
Government body
Name [1] 256541 0
beyondblue Victorian Centre for Excellence in Depression and Related Disorders
Country [1] 256541 0
Australia
Funding source category [2] 256542 0
Government body
Name [2] 256542 0
Victorian Department of Education and Early Childhood Development
Country [2] 256542 0
Australia
Primary sponsor type
Other
Name
Parenting Research Centre
Address
5/232 Victoria Parade
East Melbourne, 3002
Victoria
Country
Australia
Secondary sponsor category [1] 255843 0
University
Name [1] 255843 0
Swinburne University of Technology
Address [1] 255843 0
PO Box 218
Hawthorn, 3122
Victoria
Country [1] 255843 0
Australia
Other collaborator category [1] 1125 0
Hospital
Name [1] 1125 0
The Royal Children's Hospital
Address [1] 1125 0
Flemmington Parade
Parkville
Victoria, 3052
Country [1] 1125 0
Australia
Other collaborator category [2] 277838 0
Hospital
Name [2] 277838 0
Monash Medical Centre
Address [2] 277838 0
246 Clayton Rd, Clayton VIC 3168
Country [2] 277838 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258584 0
The Royal Children's Hospital Human Research Ethics Committee
Ethics committee address [1] 258584 0
Ethics committee country [1] 258584 0
Australia
Date submitted for ethics approval [1] 258584 0
25/01/2010
Approval date [1] 258584 0
19/04/2010
Ethics approval number [1] 258584 0
29134
Ethics committee name [2] 290614 0
Southern Health
Ethics committee address [2] 290614 0
Ethics committee country [2] 290614 0
Australia
Date submitted for ethics approval [2] 290614 0
Approval date [2] 290614 0
05/07/2012
Ethics approval number [2] 290614 0
12103B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30857 0
Dr Naomi Hackworth
Address 30857 0
Parenting Research Centre
Level 5, 232 Victoria Parade, East Melbourne, VIC 3002
Country 30857 0
Australia
Phone 30857 0
+61 3 8660 3581
Fax 30857 0
Email 30857 0
[email protected]
Contact person for public queries
Name 14104 0
Dr Naomi Hackworth
Address 14104 0
Parenting Research Centre
5/232 Victoria Parade
East Melbourne, 3002
Victoria
Country 14104 0
Australia
Phone 14104 0
+61 3 8660 3581
Fax 14104 0
+61 3 8660 3599
Email 14104 0
[email protected]
Contact person for scientific queries
Name 5032 0
Dr Naomi Hackworth
Address 5032 0
Parenting Research Centre
5/232 Victoria Parade
East Melbourne, 3002
Victoria
Country 5032 0
Australia
Phone 5032 0
+61 3 8660 3581
Fax 5032 0
Email 5032 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
SourceTitleYear of PublicationDOI
EmbaseImproving mental health of adolescents with Type 1 diabetes: protocol for a randomized controlled trial of the Nothing Ventured Nothing Gained online adolescent and parenting support intervention.2013
N.B. These documents automatically identified may not have been verified by the study sponsor.