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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]

None

Universal Trial Number (UTN)

Trial acronym

NV-NG

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Type 1 diabetes

Depression

Anxiety

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Mental Health

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]

Prevention

Intervention code [2]

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]

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]

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]

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]

The time points for data collection for both groups are T=0 (Baseline), T=6 weeks, and T=6 months.

Secondary outcome [1]

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]

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]

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]

The time points for data collection for both groups are T=0 (Baseline), T=6 weeks, and T=6 months.

Secondary outcome [3]

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]

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?

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]

The Royal Childrens Hospital - Parkville

Recruitment hospital [2]

Monash Medical Centre - Clayton campus - Clayton

Recruitment postcode(s) [1]

3052 - Parkville

Recruitment postcode(s) [2]

3168 - Clayton

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

beyondblue Victorian Centre for Excellence in Depression and Related Disorders

Address [1]

PO Box 6100,
Hawthorn West
Victoria 3122
Australia

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Victorian Department of Education and Early Childhood Development

Address [2]

35 Spring Street
Melbourne, 3000
Victoria

Country [2]

Australia

Primary sponsor type

Other

Name

Parenting Research Centre

Address

5/232 Victoria Parade
East Melbourne, 3002
Victoria

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Swinburne University of Technology

Address [1]

PO Box 218
Hawthorn, 3122
Victoria

Country [1]

Australia

Other collaborator category [1]

Hospital

Name [1]

The Royal Children's Hospital

Address [1]

Flemmington Parade
Parkville
Victoria, 3052

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Monash Medical Centre

Address [2]

246 Clayton Rd, Clayton VIC 3168

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Royal Children's Hospital Human Research Ethics Committee

Ethics committee address [1]

The Royal Children's Hospital
Flemmington Rd
Parkville
Victoria 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

25/01/2010

Approval date [1]

19/04/2010

Ethics approval number [1]

29134

Ethics committee name [2]

Southern Health

Ethics committee address [2]

Research Directorate
Level 4, Main Block
Monash Medical Centre
Clayton Victoria 3168

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

05/07/2012

Ethics approval number [2]

12103B

Summary

Brief summary

Evidence suggests that young people with Type 1 diabetes (T1D) are vulnerable to a range of mental health difficulties, including depression and anxiety. Furthermore this vulnerability can be heightened when these young people are isolated from support services, such as is the case for those living in rural areas or experiencing social isolation. The study aims to assist adolescents with T1D and their parents to manage the psychosocial impact of their condition, improve their mental and physical health outcomes, and reduce their risk taking behaviour. The study has two phases. Phase 1 is an interview study of parents (n=10) of adolescents with T1D who are prepared to discuss their experiences of parenting a child with diabetes in relation to their preferences and needs for treatment and internet based interventions. Findings from the parent interviews and an earlier needs analysis study of rural adolescents with T1D and their parents, conducted by the researchers, will be used to revise and supplement the prototype NV-NG adolescent intervention with a parenting intervention. The parent component will be based on an existing parenting program and associated web-resources and will result in an integrated adolescent and parenting program, which will be evaluated in Phase 2 (the Evaluation Phase). The evaluation phase will comprise a randomised control trial (with a wait group control) to evaluate the effectiveness of the NVNG program with a sample of approximately 120 (60 intervention, 60 wait group) adolescents aged 13-18 and one of their parents (n=120, 60 intervention, 60 wait group control). Adolescent/parent dyads will be recruited by a rolling recruitment strategy through The Royal Children’s Hospital Diabetes Outreach Clinics and Monash Medical Centre, in Victoria. Pre-Post intervention/wait measures will be administered via online questionnaires at baseline (t=0), on completion of the program (t=6weeks); and 6 months after completion of intervention/wait. Online questionnaires completed by adolescents and their parents will assess a range of psychosocial factors including: negative emotions (e.g. depression, anxiety), quality of life, diabetes self efficacy, resilience, availability of social support, risk taking behaviours, diabetes self care, and perception of parent/adolescent conflict. Parent questionnaires will assess negative emotions, self efficacy, parent perception of child well being, and family conflict. In addition the adolescents’’ glycylated haemoglobin (HbA1c) results at pre-intervention and follow-up will be used as an objective measure of diabetes control. We aim to establish the extent to which positive outcomes are achieved for both adolescents and their parents.

Trial website

Trial related presentations / publications

Hackworth, N., Matthews, J., Burke, K., Petrovic, Z., Klein, B., Northam, E., . . . Cameron, F. (2013). Improving 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. BMC Public Health, 13, 1185. 

Australian Institute of Family Studies conference poster: 
Bucalo, Z., Matthews, J., Burke, K., Cann, W., & Hackworth, N. (2012, July). Theory and research behind the development of Nothing Ventured Nothing Gained (NVNG): An online intervention for adolescents with type 1 diabetes and their parents. Poster presented at the Twelfth Australian Institute of Family Studies Conference, Melbourne, VIC. 

Final report to beyondblue: 
Hackworth, N., Matthews, J., Petrovic, Z., & Coe, A. (2013). The efficacy of the Nothing Ventured Nothing Gained online adolescent and parent mental health program for the prevention of depression, anxiety and other adverse mental health problems in rural adolescents with Type 1 diabetes. Parenting Research Centre. Final report for beyondblue

Public notes

Contacts

Principal investigator

Name

Dr Naomi Hackworth

Address

Parenting Research Centre
Level 5, 232 Victoria Parade, East Melbourne, VIC 3002

Country

Australia

Phone

+61 3 8660 3581

Fax

nhackworth@parentingrc.org.au

Contact person for public queries

Name

Dr Naomi Hackworth

Address

Parenting Research Centre
5/232 Victoria Parade
East Melbourne, 3002
Victoria

Country

Australia

Phone

+61 3 8660 3581

Fax

+61 3 8660 3599

nhackworth@parentingrc.org.au

Contact person for scientific queries

Name

Dr Naomi Hackworth

Address

Parenting Research Centre
5/232 Victoria Parade
East Melbourne, 3002
Victoria

Country

Australia

Phone

+61 3 8660 3581

Fax

nhackworth@parentingrc.org.au

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

Source	Title	Year of Publication	DOI
Embase	Improving 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.

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