SPACe

Funding body/stream

NIHR - Research for Patient Benefit

Chief investigator

Dr Jacqui Clinch and Professor Margaret Fletcher

Institution

University Hospitals Bristol NHS Foundation Trust and University of the West of England, Bristol

Start date & duration

1^st February 2013 for 33 months

Amount

£239,347

Summary

Approximately 14,000 UK children (1-16 yrs) have juvenile idiopathic arthritis (JIA), causing persistent joint inflammation, often with pain, fatigue and disability, affecting all areas of life. Nearly 50% of childhood arthritis continues into adulthood, 30% having associated eye disease that can cause blindness.

For parents, diagnosis is devastating and can lead to anxiety, depression and lifestyle changes. Parent psychological distress directly affects the child's disease, further reducing child and family quality of life. Cost to both family and NHS is very high, >£100M /year (NHS alone).

Although International specialists, governments and support groups state the need to reduce the impact of childhood disease by early support for parents, how best to do this is unknown.

In long standing childhood illness (chronic pain), we have previously shown behavioural intervention, Acceptance Commitment Therapy (ACT), delivered to parents, significantly improved child, parents and families' quality of life and reduced healthcare use.  ACT enabled parents to change their behaviour in stressful child-related situations, returning to family lifestyles more independent of clinical support. ACT has not been used early in childhood disease.

We aim to evaluate the effect of ACT delivered to parentsearlyin JIA, hypothesising that this may impact directly and indirectly on the child's disease, significantly reducing burden on the NHS. This may prove important for other childhood conditions.

This feasibility study will inform a full trial. Primary carers for 84 children recently diagnosed with JIA will receive normal care (36 parents) or normal care plus ACT (48 parents). Using questionnaires, interviews and focus groups we will establish whether

we can:

-          recruit sufficient families;

-          deliver the intervention successfully to this group;

-          collect measures of impact and health costs appropriately.

Study design reflects families' advice on the study and their continued involvement.

Output of the research and impact

Engaging with health care planners, practitioners

Although definitive outcome data will not be acquired during the feasibility phase, we plan to publish any findings which may influence others in how they prepare similar studies. This will include formal feedback to participants, through spoken and visual presentations and written report, to ensure any messages we give are true reflections of their experience as well as highlighting issues identified as important and relevant by the researchers. Should the intervention prove cost and clinically effective in the subsequent full trial, a programme of awareness-raising to both clinical services and commissioners would be planned. This would include presentations to all specialist centres in the UK with practical advice on how to introduce this practice, and presentation to NICE (and thus to the DoH) for consideration for inclusion in all relevant guidelines/guidance, reflecting the National Children's Framework 2010.

The qualitative work will provide information that is crucial to the development of a full scale Randomised Controlled Trial and will be published in its own right. In addition to the implications for the main trial, the findings from the parents and patients is important feedback for the Department of Health who are currently exploring better ways of providing for the health related needs of children and young people with chronic ill health.

Patient and public involvement

The subject area (support for parents of young people with Juvenile Idiopathic Arthritis) has been identified nationally by the Department of Health (DoH) with patient /parent input, as a priority research theme for this patient group. Consumer involvement in this study has been sought through the UK NIHR clinical research networks, Arthritis

Research UK Paediatric Rheumatology Clinical Studies Group (CSG).

One member of the CSG said:"This is something that as a parent I think is hugely important. I also thought that the fact that this recognises the differences in the supports and interventions that different parents may need is good to see".

One CSG consumer member is a co-applicant and was involved in refining the application.

We have established a dedicated forum for this study comprising young people with Juvenile Idiopathic Arthritis (JIA) and their parents, to ensure the continuing relevance of the research for them and appropriate study design and outcome measures are included in the trial. In brief, their input resulted in fundamental changes to the protocol, such as (i) The need to provide the intervention outside the tertiary centre to facilitate attendance, and (ii). The focus and nature of the outcome measures, especially for the young people.

In addition, the forum thought that support for parents was so important that all parents in the study will be offered the opportunity to attend informal parents' group meetings at which they can meet other parents and talk with staff at the end of the study. This addresses the priority raised by the forum while recognising that the intervention is as yet unproven and will be linked to study feed-back sessions for parents. The practicalities of intervention delivery have also been directly influenced by the forum which identified child care as essential for those parents unable to arrange alternative care, and identified optimal timing and period of the proposed sessions. These considerations are apparent in the protocol.

Aims of active involvement are to ensure the study remains responsive to the parental and young people's perspectives. We proactively, rather than reactively, use the precious resource of the combined consumer experience when managing the study. The parents' and young people's forums, alongside the CSG consumer representatives, work with the study team to design study information resources, and advise on study conduct and dissemination strategies.

As members of the steering group and through the forum, parents directly influence study outputs and decisions about dissemination. All parent advisors will be asked to input into and review the final report's content and presentation. Child/young person advisors will assist with determining the content and structure of a young persons' version of the report.

Internet and teleconference based activity will be essential to support ongoing involvement for parent and child advisors/forum group members, and is costed for along with travel and child care expenses.