Title: Feasibility study for an RCT to evaluate a behavioural intervention for parents early in the diagnosis of juvenile idiopathic arthritis. SPACe - Supporting Parents with A Child with arthritis
Funder: Department of Health (England)

Abstract: Background Juvenile Idiopathic Arthritis (JIA), a rapid onset, chronic, debilitating disease, affects children of all ages. Joints are chronically inflamed causing pain and disability, impacting significantly on a child's physical and psychosocial development, family/school life and family finances. Approximately 14,000 UK children are affected (prevalence 1:1000), up to 50% having active disease into adulthood(2,13,23). For parents, diagnosis is devastating. Ensuing distressed parental responses adversely impacts directly on child (disease status, anxiety, depression, function), family (health seeking behaviour, parent and sibling morbidity) and social functioning (school/work attendance, leisure activities)(1,3). The economic burden of JIA is significant for families and State(24,25). Estimated total NHS costs are > £100M/annum(16-18,26) allowing for current therapies (≤£10,000/yr/child recipient). It is widely believed that early provision of parent psychological help and support in JIA and other childhood diseases will improve child health outcomes and reduce healthcare use(1,15,19). Acceptance and Commitment Therapy (ACT, a form of cognitive behavioural therapy, CBT)(11,27,28), has been delivered to parents of children disabled by long term pain. This enabled parents in overwhelming stressful situations to change behaviour; making wise, appropriate choices for their children despite urges to be overprotective, reactive and seek healthcare inappropriately. Child, parent and healthcare outcomes all significantly improved (e.g. 50% children returned to fulltime school)(11,21). The effects on adults are sustained(10). ACT has not been delivered to parents early in childhood disease. Hypothesis By facilitating parent behaviour change early in families with recently diagnosed JIA we hypothesise a significant, sustained improvement in child outcome, family quality of life (QoL) and healthcare usage. This may have implications in other childhood diseases. Aims To determine the feasibility of a full multi-centre RCT of ACT delivered to parents within a year of their child being diagnosed with JIA. Specifically to: refine patient recruitment and outcome measures determine the delivery and acceptability of comparing the ACT intervention with usual care determine data sources and optimise data collection methods for health economic analysis for full RCT Plan of investigation 84 parents (main carer) whose child (2-16 years) has been diagnosed with JIA during the previous 12 months will be randomised to receive normal care plus intervention, or normal care only (control). Intervention parents will form groups of 8, 6 groups in total across 3 sites, Bristol (2 groups), Liverpool (3) and Taunton (1), a satellite centre included on parents’ advice. 6 control parents will be recruited per group per site. The intervention will be delivered by a clinical psychologist in four sessions over 2 weeks, per group, demonstrably the most effective format. All parents and their children with JIA will complete psychological and health questionnaires at study entry, 6 and 12 months post intervention; additional data collected for economic analysis at 3 and 9 months. A nested qualitative study will examine acceptability and feasibility of recruitment processes, randomisation, retention, outcome assessment and parents intervention attendance. Brief interviews with all participating parents will occur at 1 month post intervention, interviews with a purposive sample of 24 parents (intervention groups) 12 months after intervention. Age-appropriate group interview techniques with a sample of young people (n=12) whose parents received ACT will explore changes in family life since taking part. Clinical staff interviews (n=9) will identify barriers to recruitment and retention and seek solutions. Perspectives of parents declining to participate or leaving the study early will be sought. Potential benefits Patient: improved emotional /physical functioning, school attendance, family QoL Parent: improved psychosocial functioning, work attendance NHS: reduced resource use including emergency visits, inpatient and outpatient admissions and input from the multidisciplinary team .


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