标题：A community-based intervention (Young SMILES) to improve the health-related quality of life of children and young people of parents with serious mental illness: randomised feasibility protocol
摘要：Children and young people of parents with mental illness (COPMI) are at risk of poor mental, physical and emotional health, which can persist into adulthood. They also experience poorer social outcomes and wellbeing as well as poorer quality of life than their peers with ‘healthy’ parents. The needs of COPMI are likely to be significant; however, their prevalence is unknown, although estimates suggest over 60% of adults with a serious mental illness have children. Many receive little or no support and remain ‘hidden’, stigmatised or do not regard themselves as ‘in need’. Recent UK policies have identified supporting COPMI as a key priority, but this alone is insufficient and health-related quality of life has been neglected as an outcome. An age-appropriate standardised intervention for COPMI, called Young SMILES, was developed in collaboration with service users, National Health Service (NHS) and non-NHS stakeholders in our previous work. This protocol describes a randomised feasibility trial comparing Young SMILES with usual care, involving 60 families that will be identified through third sector organisations and NHS services, and recruited and randomised on a 1:1 basis to receive Young SMILES or usual care. Outcomes of the feasibility trial are rates of recruitment, follow-up and withdrawals, intervention uptake, and engagement. The optimal child-reported outcomes will also be determined alongside the assessment of resource use. A qualitative evaluation conducted at 3-months will explore the experiences and views of children and young people as well as parents accessing the intervention and the facilitators delivering the intervention. This paper details the rationale, design, training and recruitment methods for a feasibility study to inform the design and effective implementation of a larger scale randomised controlled trial of Young SMILES. ISRCTN36865046 , registered 18 December 2015.
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