Title: Assessment of a web-based tool for parents of children with Juvenile Idiopathic Arthritis (JIA) coupled with standard care, versus standard care alone: a randomised controlled trial
Funder: Department of Health and Social Care

Abstract: 'The diagnosis of a child with a chronic condition produces an emotional crisis for all family members. How well the parents are able to cope with this crisis will affect their ability to participate in their child s treatment'1. Previous research suggests that even in a well-supported service, parents can have difficulties in managing their child s JIA, and tailored information and support is necessary2. This study focuses on the potential of using an online intervention to support parents of children with JIA. Health is one of the most visited areas of the web but website content is unregulated and often not validated. Most current websites for JIA are restricted to giving information only, do not provide training in behavioural techniques for dealing with the daily issues in JIA and to the best of our knowledge have not undergone formal evaluation. In response to this the CHARMS JIA Website for Parents has been systematically developed with healthcare professionals and parents of children with JIA. The aim of this trial is to evaluate the benefits to parents and children of having access to this website in combination with standard clinical care when compared to standard care alone. Principal research question: In parents of children newly diagnosed with JIA, does an internet-based intervention that contains information and techniques to manage their child's JIA integrated with the clinical service, when compared with standard care, lead to a reduction in parenting stress? Secondary research questions: a) Does a specially designed online intervention, when offered to parents of children newly diagnosed with JIA in addition to standard clinical care: improve parents' ability to manage their child's arthritis? enhance parents' satisfaction with the healthcare received? improve their child's health-related quality of life? reduce healthcare utilisation? b) Is there a relationship between the level of website usage and these outcomes? Plan of investigation Participants Parents who attend paediatric rheumatology clinics at participation sites and meet the inclusion criteria will be invited to take part in this randomised controlled trial. Inclusion criteria Parents of children aged up to and including 12 years who have been newly diagnosed (within 1 month) with JIA according to internationally agreed criteria3. Parents aged 18 years or over Ability to understand written and spoken English Exclusion criteria Identifiable psychosis or dementia in parents Parents with major literacy problems Procedures Parents will be approached to take part in the trial when they attend a routine rheumatology appointment with their child. Parents who agree to participate will be asked to complete a baseline questionnaire (see Table 1 for a full list of measures). Once the baseline questionnaire is completed participants will be randomised to either the control arm who receive standard care or the intervention arm who are given 12-months access to the website in addition to standard care. Follow Up Evaluations Participants will be asked to complete a follow-up questionnaire at 4 and 12 months post-randomisation (Table 1). Follow-up questionnaires will be sent by the research assistant to the participant s home at 4 and 12 months post randomisation along with a freepost envelope for returning them to the research office. Outcomes: The primary outcome is parenting stress at 4 months post-randomisation. Secondary outcomes include measures of parent mood and self-efficacy to manage their child's JIA, child HRQoL and healthcare utilisation Potential benefits to participants, patients and NHS If the website is effective, it will enhance parents ability to manage their child s JIA which will reduce parenting stress and help to improve their child s HRQoL. This should also result in a reduction in unplanned contacts with health professionals therefore reduce healthcare utilisation and costs to the NHS.

Lay abstract: Juvenile idiopathic arthritis (JIA) is defined as inflammation of one or more joints that starts before age 16, lasts more than six weeks and is of unknown origin. JIA affects approximately 1 in 1000 children and can cause considerable pain and disability. Having a child with JIA presents many challenges. Parents may be faced with their child's pain, distress and physical difficulties, as well as managing medication, hospital visits and uncertainty about the future. Many parents experience considerable stress. Parental distress and functioning have been found to be related to child outcomes, therefore interventions that offer parents training to help them manage their child s illness are important for both parents and child. Psychological interventions for parents of children with chronic illness have been found to improve parent and child outcomes. However, these usually involve several face-to-face sessions, which may be difficult for parents to fit into their lives. An alternative approach is to provide the intervention online which would offer round-the-clock access and enable parents to access information when concerns arise. This study will test whether a specially designed website helps to reduce parenting stress and thereby improves the child's quality of life. Parents of children newly diagnosed with JIA will be asked to take part in a randomised controlled trial (RCT) when they attend rheumatology clinic appointments. Those who agree will fill in a questionnaire asking about parenting stress, how they cope with their child's JIA and about their child's wellbeing. They will then be randomly allocated to a)12 months access to an online intervention in addition to usual clinical care, or b)usual clinical care alone. After 4 months and 12 months, parents will be asked to repeat the questionnaire. We will compare outcomes for parents who were given website access to those who received usual care alone.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: INFLAMMATORY AND IMMUNE SYSTEM