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Alderson H, Kaner E, Brown R, et al. Behaviour change interventions to reduce risky substance use and improve mental health in children in care: the SOLID three-arm feasibility RCT. Southampton (UK): NIHR Journals Library; 2020 Sep. (Public Health Research, No. 8.13.)

Cover of Behaviour change interventions to reduce risky substance use and improve mental health in children in care: the SOLID three-arm feasibility RCT

Behaviour change interventions to reduce risky substance use and improve mental health in children in care: the SOLID three-arm feasibility RCT.

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Chapter 1Introduction

Structure of the report

The report is structured as a series of eight chapters, detailing the design, management and outcomes of both the formative research and the pilot feasibility study. The report begins by providing the background to the research, outlining the rationale informing the design and conduct of the study.

Chapter 1 ends with an overview of the project aims and objectives. Following this, a chapter is dedicated to each of the core components of the study.

Chapter 2 details the patient and public involvement (PPI) work that has taken place throughout the study.

Chapter 3 explores the formative phase of the study and the development of the intervention materials, as well as the training and supervision provided to drug and alcohol staff during the delivery of the interventions.

Chapter 4 reports the design, methods and results of the drug and alcohol treatment provider survey.

Chapter 5 provides the design, methods and results of the pilot feasibility trial.

Chapter 6 provides the design, methods and results of the parallel qualitative process evaluation.

Chapter 7 details the design, methods and results of the health economic evaluation of the study.

Finally, Chapter 8 draws together the main findings from the pilot feasibility study, alongside an assessment of whether or not the study met its aims and objectives, before detailing lessons learnt and recommendations for a future definitive trial.

Ethics approval

This study was granted a favourable ethics opinion by Newcastle and North Tyneside 1 National Research Ethics Service Committee (16/NE/0123). Newcastle University acted as trial sponsor.

Research management

The Supporting Looked After Children and Care Leavers In Decreasing Drugs, and alcohol (SOLID) Trial Management Group (TMG) was responsible for ensuring the appropriate and timely implementation of the trial. The TMG met bi-monthly and comprised the chief investigator, project co-ordinator, co-applicants and researchers working on the project. Professor Raghu Lingam, succeeded by Professor Eileen Kaner, chaired this group.

A Trial Oversight Committee (TOC) was appointed to provide an independent assessment of the progress the trial was making and to help determine if a future definitive trial was merited. This group met annually to oversee trial progress, with particular attention paid to recruitment, retention, adherence to trial protocol, participant safety and any new information deemed relevant to the research question. Professor Monica Lakhanpaul chaired this group. The agreed terms of reference can be seen in the Report Supplementary Material 1.

Research governance

This trial was conducted in compliance with the approved protocol and adhered to the UK policy framework for health and social care, good clinical practice guidelines, the relevant standard operating procedures and other regulatory requirements as applicable.

All researchers complied with the requirements of the General Data Protection Regulation, 2018,1 with regard to the collection, storage, processing and disclosure of personal information, and have upheld the Act’s core principles.

Researcher-administered questionnaires completed by participants online were identified by a unique study identification code. Only members of the research team are able to associate this unique study identification code with participant identifiable data needed for record linkage and participant contact.

All study records and investigator site files were stored in the Institute of Health and Society at Newcastle University in a locked filing cabinet with restricted access.

Amendments to study protocol

It was the responsibility of the research sponsor to determine if an amendment was substantial or not. A number of amendments have been made with the mutual agreement of the chief investigator, sponsor and the TOC.

Substantial amendments were submitted to the Research Ethics Committee by the chief investigator, on behalf of the sponsor, and changes to protocol were not implemented until approval was in place. The details of the substantial amendments made throughout the trial are shown in Report Supplementary Material 2.

Background to the research

Introduction

Drug and alcohol use is a major public health problem that places a significant economic strain on the NHS and society.2 Substance use accounts for 11% of the total burden of disease, calculated as disability-adjusted life-years lost, in high-income countries.3 It was estimated in 2013 that alcohol-related harm costs the UK £21B annually,4 with an additional £15.4B estimated to result from drug addiction.5 The Modern Crime Prevention Strategy 2016 states that alcohol is a key driver of crime.6 The north-east has the record highest rate of alcohol-related deaths in England.7

Risky substance use in adolescence predicts adult alcohol and drug use and significantly increases the risk of adult mental health disorders, crime and poverty.810 There have been some positive trends over recent years with regard to young people’s substance use and related risky behaviours. For example, fewer young people (aged 16–24 years) in England report drinking alcohol regularly,11,12 and more abstain from using alcohol than in previous years.4,13 Although there has been an overall fall in drug use in teenagers over the last decade, the UK is still in the top five for lifetime use of cannabis and other illicit drugs in 15- to 16-year-olds and the top 10 for binge drinking (heavy sessional or risky single-occasion drinking) in the last 30 days across 36 European countries.14 In a 2016 longitudinal survey of English secondary school pupils aged 11–15 years, 19% had tried smoking and 44% had tried alcohol.15 In addition, 24% had tried drugs, compared with 15% in 2014, which the authors believe is accounted for by new questions on novel psychoactive substances (NPSs) and nitrous oxide.15 The most recent figures from the National Drug Treatment Monitoring System (NDTMS) on young people accessing specialist services show that the number of adolescents accessing such services continues to decline year on year.16 However, the number of younger people (those aged < 14 years) accessing services has increased by 10% since 2014–15. The most common drug used problematically by those in treatment was cannabis (88% of services users reported a problem with this drug), followed by alcohol at 49%. Eleven per cent of those in treatment reported problematic ecstasy use, 9% used cocaine, 3% used amphetamines and 4% displayed NPS use.16 Encouragingly, the most recent NDTMS statistics on young people’s substance use suggest a decrease of 45% in problematic NPS use since 2016,16 perhaps because these ‘legal highs’ became illegal in May 2016.

The following sections highlight the specific health, substance use, education, employment and offending status of children in care, henceforth used to make reference to looked-after children and care leavers.

Children in care and health

In the UK context, looked-after children are children up to the age of 18 years who are under the legal guardianship of local authorities.17 Such young people are described as being in ‘out-of-home’ care in both the USA and Australia.18,19 Care leavers are young adults who were previously under the legal care of local authorities and are still entitled to support, depending on their circumstances. Care leavers are typically aged 18 to 21 years, but can range in age from 16 to 25 years depending on their circumstances, such as being in education.17

On 31 March 2018 there were 75,420 children in care in England, which represents 64 children per 10,000 of those aged < 18 years.20 The number of children ‘looked after’ in England has risen steadily over the past 9 years. The main reasons for children and young people entering the care system are abuse or neglect (61%), family dysfunction (15%), family acute stress (8%) and absent parenting (7%).20

Children in care may live in a range of placement types, such as children’s residential homes or secure units with foster carers or relatives, or be adopted or unaccompanied asylum seekers, or can remain with birth parents while under supervision from social workers.21 Recent evidence suggests that levels of placement stability for children in care are low. In 2016–17, the mean placement duration was 314 days (10.5 months) and the median was 140 days (just under 5 months).20 Twenty-four per cent of placements lasted < 1 month and only 22% of placements lasted > 1 year.20 The impact of this, as Unrau and Seita explore with care-experienced adults, can have a lasting emotional impact and affect an individual’s ability to trust and build relationships.22

Children in care have multiple risk factors for substance use, poor mental health, school failure and early parenthood.23 These factors include parental poverty, absence of support networks, parental substance misuse, poor maternal mental health, early family disruption and, in the majority of cases, abuse and/or neglect.24,25

Young people who have experience of the care system are more likely than their peers to have experienced adverse childhood experiences.26,27 A Social Care Institute for Excellence report, Improving Mental Health Support for our Children and Young People, highlights the combined effects of young people’s experiences prior to care and those during care as having an impact on their mental health.28 Such experiences are associated with a number of poor long- and short-term health outcomes,29 including problematic substance use, mental health problems,30 obesity and cancer.31 For example, more than 50% of children in care rate their well-being as low, compared with only 10% of their same-age peers.32 Similarly, 50% of those in care meet the diagnostic criteria for a psychiatric disorder, compared with 10% of non-care children who have mental health issues.32 All children in care in England aged 4–16 years are required to complete an annual Strengths and Difficulties Questionnaire (SDQ) with their foster carer or main residential care worker. In 2017, 49% had a score within the normal range (score of 0–13), 12% had a borderline score (score of 14–16) and 38% had a score giving cause for concern (score of 17–40).20 Those in foster care placements had the lowest scores, 51% scored within the normal range, 13% were borderline and 36% gave cause for concern.33 By contrast, within the rest of the population of children in care, 39% were in the normal range, 13% were borderline and 47% gave cause for concern.34 The mental health needs of children in care are evident in the Children’s Commissioner 2015 report.35 Children in care significantly over-represented peers in relation to accessing specialist Community Adolescent Mental Health Services (CAMHS). Although < 0.1% of children in England are in care, they represented 4% of children referred to CAMHS.35

Longitudinal data suggest that young people who have been in care have higher levels of depression in adulthood. In the British Cohort Study (BSC70), at age 30 years, 24.2% of care leavers reported depression, compared with 12.4% of those who had not been in care.36,37 In addition, care leavers were four times more likely than their peers to self-harm in later life.38 Children in care had a nearly fivefold increased odds of at least one mental health diagnosis, including anxiety, depression or behavioural disorders [odds ratio 4.92, 95% confidence interval (CI) 4.13 to 5.85], than their non-looked-after peers, further increasing their risk of substance misuse and poor life chances.39

Evidence suggests that children in care have a higher rate of teenage pregnancy than their peers.40 Over a 14-month period in 2012–13 in Wales, children in care aged 14–17 years had a conception rate of 5.8% compared with 0.8% among peers not in the care system.

Substance use

As outlined in Introduction, risky substance use in adolescence is a predictor of adult-related alcohol and drug use, mental health disorders, crime and poverty.810 Children in care aged 11–19 years have a fourfold increased risk of drug and alcohol use compared with children not in care.41 Twenty-five per cent of children in care aged 11–19 years drink alcohol at least once a month, compared with 9% of young people not looked after. A national survey of care leavers showed that 32% smoked cannabis41 daily and data from 2012 showed that 11.3% of children in care aged 16–19 years had a diagnosed substance use problem.42,43

In the year to end of March 2017, 4.1% of children in care were identified as having a substance misuse problem (not including tobacco), with older teenagers being more likely to be identified as such (11% of 16- to 17-year-olds vs. 5% of 13- to 15-year-olds).20 Those in foster care appear to be the least at risk: 2.1% were identified as having a substance misuse issue, of whom 46% received an intervention and 42% refused an intervention. However, within the rest of the population of children in care (non-foster care placements), 10% were identified as having a substance misuse problem, 62% of whom received an intervention and 39% refused an intervention.33 In March 2018, there were 15,583 young people accessing specialist substance misuse services, of whom 7% (1093 young people) stated that they were living ‘in care’. In addition, of the 11,052 new presentations in 2017–18, in self-reports via the NDTMS, 1204 (11%) young people identified themselves as a looked-after child, 957 (9%) identified themselves as a child in need and 829 (8%) reported that they had a child protection plan in place.44 International evidence suggests that those living in institutional or residential care homes are at particular risk of legal and illegal substance misuse, compared with non-care peers and those living in other placement types.19,4547

Children in care are over-represented among drug users in later life and tend to start using substances earlier, more regularly and at higher levels than their peers.48 Relatedly, 12% of young people accessing substance misuse services are children in care,49 and this group are disproportionately represented in the criminal justice system.

Recent policies stress that children in care are a high-risk group who are vulnerable to substance misuse and linked mental health problems, as identified in Ethics approval. The 2017 Drug Strategy,49 the National Institute for Health and Care Excellence (NICE) (2017) guidelines Drug Misuse Prevention: Target Interventions50 and the NICE (2010) guidelines Alcohol Use Disorders: Prevention51 identify children in care as a ‘high-priority group’ who are at increased risk from substance-related harm. Despite this, there is limited research and an absence of cost-effectiveness data, and, at the time of writing (2019), no national guidelines on the most effective interventions to decrease risky drug and alcohol use in this group. This lack of data was highlighted by the Chief Medical Officer’s annual report for 2012,23 which stated that one of the key research areas was to assess the most effective interventions to reduce multiple risk-taking behaviour, including drug and alcohol use, in this group.23

Literature shows that risk-taking behaviour clusters in adolescence and behaviours, such as smoking, alcohol consumption and unprotected sexual intercourse, co-occur.52,53 In addition, young people who engage in any one risk-taking behaviour are likely to engage in others.54,55 The involvement in multiple risk-taking behaviours can be linked to contextual factors. The majority of young people presenting to specialist drug services have multiple and overlapping vulnerabilities in addition to substance use, such as being looked after, mental health problems, not in education, employment or training (NEET), experience of child sexual abuse, offending or domestic abuse.16 Forty per cent of 19- to 21-year-old care leavers in England are NEET compared with 13% of all 19- to 21-year-olds more broadly.34

Education

Fifty-seven per cent of children in care aged 11 years have a special educational need, a rate 40% higher than among their peers who are not in care.20 A child will be defined as having special educational needs if they have a learning problems or disability that mean that they need special education support.56 The disparity in educational achievement between young people in care and those who are not continues as they progress through the education system. At age 16 years, the average attainment score for children in care is 19.3, compared with a score of 44.5 for children not in care.20 Children in care have lower educational attainment and participation post secondary level,57 and those who enter care later (i.e. between age 10 and 15 years) do less well in secondary education than those who enter care at a younger age.58

A study of 181 children in care aged 7–15 years in an English local authority found that they performed less well than the general child population in regard to assessed mental health, emotional literacy, cognitive ability and literacy attainment.59 However, there were some positive exceptions of children performing well (16%, n = 30) and this was positively correlated with having face-to-face parental contact at least once per month and being in mainstream education. However, there was no significant relationship with the age on entering care, the primary reason for entering care, the length of time in care, or placement type.

A study of longitudinal data of Danish children born in 1995 shows that those in ‘out of home’ care settings change school more often than other young people, and that such change is associated with adverse educational outcomes.60 Longitudinal data from the UK, Finland and Germany show that, in all three countries, care leavers are more likely to have no qualifications and less likely to have a higher-level qualification than their same-age peers who have never been in care. Males, in particular, are more likely to have no qualifications.36

Literature shows that young people who truant or are excluded from school have an increased risk of alcohol and/or drug use.61 It is also reported that young people who have truanted from school are 1.85 times as likely to have consumed drugs within the past 12 months and are over twice as likely to have consumed alcohol within the past week.62

Employment

Care leavers have a higher risk of unemployment than those who have not been in care.63 Forty per cent of 19- to 21-year-olds are NEET, compared with 13% of all 19- to 21-year-olds.20 Such disadvantage and poorer outcomes last into adulthood, showing ‘a continuing legacy of adversity’ for those who have been in care, particularly in relation to education and employment.36 Across the UK, Finland and Germany, care leavers are over-represented in economically inactive categories. In the 1970 British Cohort Study, of those born in 1970, at age 30 years, 65.8% of those who had been in care had attended full- or part-time education compared with 82.1% of those who had never been in care. By age 30 years, 7.1% of care leavers were unemployed, compared with 3.1% of those who had never been in care. A total of 16.3% of care leavers were not working to take care of family/home, compared with 9.9% of those who had not been in care. In the UK, at age 30 years, care leavers were more likely to have claimed Jobseekers Allowance (4.3% vs. 1.6%), claimed income support (7.7% vs. 1.7%) and were much more likely to have been homeless or of no fixed address before the age of 25 (22.5% vs. 6.5%).36 Care leavers have three times the risk of being homeless than those who have never been in care. According to the more recent Longitudinal Study of Young People in England (now referred to as Next Steps), a birth cohort study of those born in 1989–90, care leavers at age 20 years are showing similar trends to those in the 1970 cohort at age 30 years. Those who have been in care are over-represented among the unemployed (17.9% vs. 6.2% of 20-year-olds who have not been in care).64

In line with the disrupted school attendance reported above, young people with poor attendance are more likely to leave school at 16 years of age, with few or no qualifications, and therefore are seven times more likely to be recorded as NEET.62

Offending

In the year up to 31 March 2017, 4% of children in care aged between 14 and 17 years had received a conviction, final warning or reprimand. Children in care are five times more likely to offend than all children.20 Of those in foster care and aged between 10 and 17 years, 1.2% received a conviction, final warning or reprimand, compared with 15% of children in all other placements.33 Research from the criminal justice system in Scotland showed that 34% of youth offenders had been in care. Of these offenders, 75% reported drug use (vs. 57% of those not previously in care).65

Summary of the needs of children in care and potential solutions

As highlighted in sections Children in care and health to Offending, children in care are at risk of experiencing a myriad of negative outcomes, which will affect their emotional, physical and economic prospects into adult life, resulting in a significant cost to society and increased risk of intergenerational poverty. Effective interventions for children in care could have a beneficial effect on the long-term mental and physical health of these vulnerable young people, importantly reduce health inequality and, due to their increased risk of early parenthood, potentially impact intergenerational health. In response to the needs of children in care, the SOLID trial was developed to test the feasibility and acceptability of two behaviour change interventions in an attempt to address the substantial gap in evidence relating to effective interventions for children in care residing in varying forms of placement.

Overview of the study

The study had two linked phases:

  1. A formative phase consisting of adaptation and manualisation of two behaviour change interventions for children in care to help reduce risky substance use: (1) motivational enhancement therapy (MET); and (2) social behaviour and network therapy (SBNT). Phase 1 also incorporated a national survey of drug and alcohol treatment service leads to help characterise usual care across England and identify potential collaborative centres for a definitive trial.
  2. A pilot feasibility randomised controlled trial (RCT). This second phase of the project also had a detailed process evaluation (see Chapter 5) and economic component outlined in Chapter 6.

Research aim

The SOLID pilot feasibility trial aimed to assess the feasibility and acceptability of a definitive three-arm multicentre RCT (two behaviour change interventions and care as usual) to reduce risky substance use (illicit drugs and alcohol), and improve mental health in looked-after children and care leavers (children in care aged 12–20 years).

Research objectives

The primary objectives within the SOLID pilot RCT were as follows.

Phase 1: formative study –

  • To adapt two behaviour change interventions for children in care to help reduce risky substance use (MET and SBNT). This phase was carried out with children in care, their carers (residential key workers and foster carers), drug and alcohol workers, and social workers with responsibility for children in care, to ensure acceptability and feasibility of the intervention packages.

Phase 2: pilot feasibility randomised controlled trial –

  • To conduct a three-arm pilot RCT [comparing MET, SBNT and a control (usual care)] to determine if rates of eligibility, recruitment and retention of children in care, and acceptability of the interventions, are sufficient to recommend a definitive multicentre RCT.

The secondary research objectives were as follows.

Phase 1: formative study –

  • To refine the intervention packages for integration into care pathways for children in care.
  • To conduct a survey of the leads for young people’s drug and alcohol treatment services across England to identify ‘standard practice’ within and across agencies.

Phase 2: pilot feasibility randomised controlled trial –

  • To establish response rates, variability of scores, data quality and acceptability of the proposed outcome measures for the future definitive trial (i.e. self-reported alcohol and drug use, health-related quality of life, mental health and well-being, sexual behaviour and placement stability 12 months post recruitment), to inform a sample size calculation for a definitive multicentre RCT.
  • To assess acceptability, engagement and participation with the MET- and SBNT-based interventions by children in care, their carers and front-line drug and alcohol workers.
  • To carry out a process evaluation to include fidelity of intervention delivery and qualitative assessment of the barriers to successful implementation, and to assess if key components from the MET and SBNT interventions can be combined to develop a new optimised intervention.
  • To develop cost assessment tools, assess intervention delivery costs and carry out a value of information analysis to inform a definitive study.
  • To apply prespecified STOP/GO criteria and determine if a definitive multicentre RCT is feasible, and, if so, to develop a full trial protocol.
  • To consider findings from the study as a whole in order to develop a core intervention delivery package, potentially of a single optimised intervention, linked to a theory of change model to use in the definitive trial.

The study setting

The research took place in six local authorities in the north-east of England (Newcastle, Gateshead, County Durham, Middlesbrough, Stockton and Redcar). The north-east of England is an area of increased health and social care need and has the highest rates of poverty in the country, with 24% of households living below the poverty line. The region is, however, not uniform and encompasses a mixture of urban, periurban and semi-rural areas. The percentage of black and ethnic minority groups across the region varies from 10% in Newcastle to 2% in Durham.66 The North East region had 95 children in care per 10,000 as of March 2018, far higher than the average rate for England as a whole (64 children per 10,000) (Table 1). Each local authority area provides a range of placement types, such as residential care homes, foster care placement and kinship foster care.67

TABLE 1

TABLE 1

Total numbers of children in care at end of March 2018 and number per 10,000 children under the age of 18 years

Copyright © Queen’s Printer and Controller of HMSO 2020. This work was produced by Alderson et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK562034

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