Current policy and initiatives
As far back as 1999, the Department of Health and Social Care made perinatal mental health a priority in the NHS Plan; in the recent Implementing the Five Year Forward View for Mental Health paper,86 NHS England included perinatal mental health as the only element of focus on women’s mental health. As a result, resources have been directed to support adults with mental illness in their parenting roles, particularly women with postnatal mental illness.87 In addition, an increase in whole-family assessments and recovery plans stems from national outcome strategies that tackle mental health across the lifespan as well as the transgenerational transmission of psychiatric morbidities.88,89 And deeper integration between child and adult mental health services is now advocated, alongside earlier interventions for troubled families.87,90,91
Despite this, CAPRI are neglected by social and health care services.50,92 For a range of reasons, parents with mental illness experience greater exclusion from general health and social care services, restricting the monitoring and support available to their children.50,93 Collectively, extant publications outline the roles and responsibilities services should take when supporting CAPRI in their daily lives.17
Thus, in 2015, the Department of Health and Social Care and NHS England published Future in Mind,94 outlining a 5-year strategy to make it easier for children and young people (CYP) to access high-quality mental health services in recognition of the treatment gap of around 25–35% among children and young people with a diagnosable mental health condition. It proposed a step change from a ‘tiered model of care’ (i.e. a system defined in terms of what services organisations provide) to one that responds to the needs of CYP as well as their families’ needs. Greater flexibility and leadership at a more regional level was recommended to allow different services to develop to suit local needs. Developing a ‘better offer’ for the most vulnerable children was also proposed,94 contributing to a growing body of literature highlighting the importance and gaps in provision identifying and supporting at-risk children.95
In Addressing Adversity: Prioritising Adversity and Trauma-informed Care for Children and Young People in England,96 Young Minds recommended investment in trauma-informed models of care with development of a common framework to identify at-risk children, reducing heterogeneity in how ‘vulnerable’ is defined across services, and proposed that adverse childhood experiences (ACE)/childhood adversity become a local commissioning priority. In response, new legislative requirements have been placed on local authorities, Clinical Commissioning Groups (CCGs), schools, police, and other organisations and agencies to work collaboratively to provide early identification and help for vulnerable young people, specifically mentioning children exposed to parental mental illness.97
Thus, successive policy reflects a gradual understanding that CAPRI are unlikely to get the help they need simply as a by-product of their parents’ care, and recognition across different countries that a framework of responses dedicated to them is required (Table 1).
| Publication | Year | Author |
|---|---|---|
| Child and Adolescent Mental Health in Enlarged Europe98 | 2007 | The EU |
| Child Welfare Act99 | 2007 | Ministry of Social Affairs and Health (Finland) |
| NSW Children of Parents with a Mental Illness (COPMI) Framework for Mental Health Services 2010–2015 100 | 2010 | Department of Health (Australia) |
| Social and Emotional Wellbeing for Children and Young People 73 | 2011 | National Institute for Health and Care Excellence (UK) |
| Think Child, Think Parent, Think Family: A Guide to Parental Mental Health and Child Welfare 50 | 2011 | Social Care Institute for Excellence (UK) |
| Children First: National Guidance for the Protection and Welfare of Children 101 | 2011 | Department of Children and Young People (Ireland) |
| Working with Troubled Families: A Guide to the Evidence and Good Practice 88 | 2012 | Department for Communities and Local Government (UK) |
| Future In Mind94 (guidance outlining aims for transforming how CAMHS services are delivered nationally) | 2015 | Department of Health and Social Care (UK) |
| Children’s and Young People’s Strategy 2017–2027 102 | 2016 | Department of Education (Northern Ireland) |
Although mental health services are becoming more accessible to CYP,103 CAPRI are often not mentally ill. Instead, they are in need of recognition for the challenges they face day-to-day, of monitoring and of recourse to non-stigmatised help when they need it.6,15,68
One possible avenue for such provision is the Improving Access to Psychological Therapies for Children and Young People service or IAPT-CYP.104 NHS England aims to upskill these and other workforces involved in the care of CYP and to strengthen the collaboration between existing services. IAPT-CYP also promotes more evidence-based practice and robust outcome monitoring in routine services.103,104 However, there remain challenges to increasing the accessibility of a service for CYP who commonly do not have a mental health problem when CAMHS is being prioritised, hence the need to consider other supports within non-clinical settings.
Aims and objectives of the feasibility study
This research responded to the 2014 NIHR HTA programme call to answer the related questions of whether or not (1) it is possible to develop a community-based intervention to enhance the HRQoL of children and adolescents who live with a primary carer with SMI, and (2) such an intervention is suitable for a future trial.
The initial study protocol set out our aim and preliminary objectives [available on the project web page: www.journalslibrary.nihr.ac.uk/programmes/hta/142901/#/ (accessed 1 March 2020)]. These objectives were revised prior to commencing recruitment and published in our updated protocol paper.105
For clarity, Table 2 presents the original preliminary objectives, the subsequently revised objectives from that paper and the rationale for any changes alongside each.
| Preliminary objectives (HTA, 2014) | Revised objectives105 | Justification for change |
|---|---|---|
| A. To randomise children, adolescents and their parents to the intervention or treatment as usual pathways in a wait-list control design | 1. Using a feasibility RCT comparing the intervention developed in our earlier work with usual care to determine uptake, adherence and follow-up rates | Waiting list control was mooted as a comparator in much earlier versions of the protocol as requested by reviewers. However, it was rejected because study sites were not able to deliver twice the number of Young SMILES groups – once for the intervention group and once for the control group – within the given time frame and costs. Thus, the comparator was always usual care and not waiting list, as stated in objective A. In objective B, the comparator is stated as usual care |
| B. To estimate uptake, intervention adherence and retention to follow-up rates in a RCT comparing the intervention with usual care | Preliminary objective B was merged with objective A to make a revised objective 1 | |
| C. To determine which child/adolescent self-completed outcome measures are able to capture the effects of the intervention over time, especially in the primary outcome measures identified as important by the stakeholders | 2. To determine, from a battery of outcome measures, the most appropriate primary outcomes with which to assess any effects of the intervention over time, considering the areas identified as important by the stakeholders | The preliminary and revised objectives are the same |
| D. To obtain estimates of intervention effects and measures of variability on the selected outcome measures to inform sample size calculations for a definitive trial | Preliminary objective D was removed as inappropriate because in our feasibility trial we are not powered to estimate intervention effects | |
| E. To optimise and pilot a data collection tool to capture the most relevant aspects of families’ resource utilisation (including Young SMILES) over time | 3. To develop and pilot a data collection tool relevant to family resource use over time | Preliminary objective E and revised objective 3 remained the same |
| 4. To determine if the intervention is acceptable to CAPRI, their parents and the practitioners delivering the intervention | Objective 4 was added as part of the revised objectives (there was no corresponding one in the preliminary objectives). This is because assessing the intervention’s acceptability via qualitative work was a major aspect of the feasibility study and the preliminary objectives did not reflect this | |
| 5. To establish if the intervention can be implemented successfully within third-sector and NHS settings | Objective 5 was added as part of the revised objectives (there was no corresponding preliminary objectives). This is because the study had two distinct implementation models (NHS and third sector) and the preliminary objectives did not reflect this |
This report includes a set of final objectives, which are reproduced with permission from Gellatly et al.105 (This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: https://creativecommons.org/licenses/by/4.0/. The text includes minor additions and formatting changes to the original text), and are worded differently to help with the presentation of our results across the report, our ability to make judgements about whether or not we have delivered against these objectives and, furthermore, whether or not a full randomised controlled trial (RCT) is feasible.
Table 3 presents the final objectives for this report and maps them on to our published objectives.105
| Final objectives in HTA report | Mapping onto Gellatly et al.105 objectives |
|---|---|
| A. To co-produce (with stakeholders) an intervention that was acceptable to families and feasible to deliver in the NHS and in the community with support from health and non-health professionals | This objective captures the primary aim of the study (as stated in the original 14/29 HTA call) and also incorporates published objectives 4 and 5 |
| 4. To determine if the intervention is acceptable to CAPRI, their parents and the practitioners delivering the intervention | |
| 5. To establish if the intervention can be implemented successfully within third-sector and NHS settings | |
| B. To determine the rates of intervention uptake and adherence, and of completed follow-up measures | This is the same as published objective 1 |
| 1. Using a feasibility RCT to compare the intervention developed in our earlier work with usual care to determine uptake, adherence and follow-up rates | |
| C. To identify appropriate outcome measures and estimate their data missingness | This is a revised version of objective 2. We cannot assess intervention effects on specific outcomes in a feasibility study. Therefore, we describe our objective more accurately here in terms of feasibility of completion of outcome collection at baseline and follow-up (assessed by data missingness) |
| 2. To determine, from a battery of outcome measures, the most appropriate primary outcomes with which to assess any effects of the intervention over time, considering the areas identified as important by the stakeholders | |
| D. To develop a child resource utilisation questionnaire and estimate its data missingness | This is the same as objective 3 below, revised to include ‘data missingness’ as a more accurate objective of feasibility for data collection. The final objective also specifies that resource utilisation refers to the child and not the family |
| 3. To develop and pilot a data collection tool relevant to family resource use over time | |
| E. To capture the experiences of children and parents who participated in the intervention and of professionals who referred or supported families to participate in the intervention | This is an objective that maps onto objectives 4 and 5 of Gellatly et al.105 that conveys the qualitative work that was a large part of this study to determine acceptability and feasibility |
| 4. To determine if the intervention is acceptable to CAPRI, their parents and the practitioners delivering the intervention | |
| 5. To establish if the intervention can be implemented successfully within third-sector and NHS settings |
Report roadmap
The final objectives, which we address in this report, remain focused on the basic feasibility criteria of being able to recruit and randomise participants (CAPRI and their parents) to the newly co-created Young SMILES intervention, as well as to be able to maintain participation of recruited individuals up to, and including, follow-up data collection. The final objectives place greater emphasis on participant and staff experiences as indicators of acceptability of Young SMILES and of its deliverability inside and outside the NHS.
These objectives can be broadly divided across the quantitative and qualitative aspects of the research report. The first 18 months of work is described in Chapter 3. It included study set-up and recruitment of sites, a process delayed significantly by coinciding with the newly formed Health Research Authority and by changes in the organisation of our NSPCC partner, as described in detail in Appendix 1. Subsequently, development, manualisation and training of NHS and non-NHS staff in the new, child-centred intervention (i.e. Young SMILES) was completed with significant input from children, young people and their parents. Chapter 3 describes the development and manualisation of the intervention with stakeholders over a 12-month period. Training was undertaken across three sites in Warrington, Coventry and Newcastle.
The feasibility study, testing our ability to deliver the new intervention, is described in Chapters 4–6 and constituted the second part of the 3-year study of two halves. However, the fact that the original timeline for recruitment was foreshortened by 11 months as a result of delays beyond the study team’s control (and described in detail in Appendix 1, Table 31) is, in our view, central to our final reporting of results and our recommendations about what future research activity should look like (i.e. the feasibility of a future trial).
Of note, progression criteria were not a part of the current study design.
Chapter 8 uses a matrix to present the study’s findings and to make a judgement as to whether or not a future full RCT is feasible based on established norms of uptake, adherence and follow-up rates, and also based on the reported experiences of children, parents and staff.
Chapter 3 discusses the modelling phase of an intervention called Young SMILES, which drew on qualitative and co-production methods to put children’s HRQoL needs at the centre of service delivery considerations.