None listed
Conditions
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.
Interventions
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
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.
Sponsors
Parenting Research Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
13 Years to No maximum
Healthy volunteers
No
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).
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.
Outcome results
None listed