Humanistic counselling plus pastoral care as usual versus pastoral care as usual for the treatment of psychological distress in adolescents in UK state schools (ETHOS):a randomised controlled trial

Background About one in seven adolescents have a mental health disorder in England, UK. School counselling is one of the most common means of trying to address such a problem. We aimed to determine the effectiveness and cost-effectiveness of school-based humanistic counselling (SBHC) for the treatment of psychological distress in young people in England, UK. Methods We did a two-arm, individually randomised trial in 18 secondary state-funded schools across the Greater London area of the UK. Participants were randomly assigned (1:1) using a centrally secure randomisation procedure with random permuted blocks to either SBHC plus schools' pastoral care as usual (PCAU), or PCAU alone. Participants were pupils aged 13–16 years who had moderate-to-severe levels of emotional symptoms (measured by a score of ≥5 on the Strengths and Difficulties Questionnaire Emotional Symptoms scale) and were assessed as competent to consent to participate in the trial. Participants, providers, and assessors (who initially assessed and enrolled participants) were not masked but testers (who measured outcomes) were masked to treatment allocation. The primary outcome was psychological distress at 12 weeks (Young Person's Clinical Outcomes in Routine Evaluation measure [YP-CORE]; range 0–40), analysed on an intention-to-treat basis (with missing data imputed). Costs were assessed at 24 weeks (Client Service Receipt Inventory and service logs). The trial was registered with ISRCTN, number ISRCTN10460622. Findings 329 participants were recruited between Sept 29, 2016, and Feb 8, 2018, with 167 (51%) randomly assigned to SBHC plus PCAU and 162 (49%) to PCAU. 315 (96%) of 329 participants provided data at 12 weeks and scores were imputed for 14 participants (4%). At baseline, the mean YP-CORE scores were 20·86 (SD 6·38) for the SBHC plus PCAU group and 20·98 (6·41) for the PCAU group. Mean YP-CORE scores at 12 weeks were 16·41 (SD 7·59) for the SBHC plus PCAU group and 18·34 (7·84) for the PCAU group (difference 1·87, 95% CI 0·37–3·36; p=0·015), with a small effect size (0·25, 0·03–0·47). Overall costs at 24 weeks were £995·20 (SD 769·86) per pupil for the SBHC plus PCAU group and £612·89 (1224·56) for the PCAU group (unadjusted difference £382·31, 95% CI £148·18–616·44; p=0·0015). The probability of SBHC being more cost-effective reached 80% at a willingness to pay of £390 for a 1-point improvement on the YP-CORE. Five serious adverse events occurred for four participants in the SBHC plus PCAU group, all involving suicidal intent. Two serious adverse events occurred for two participants in the PCAU group, one involving suicidal intent. Interpretation The addition of SBHC to PCAU leads to small reductions in psychological distress, but at an additional economic cost. SBHC is a viable treatment option but there is a need for equally rigorous evaluation of alternative interventions. Funding This work was supported by the Economic and Social Research Council (grant reference ES/M011933/1)

Effectiveness and cost-effectiveness of humanistic counselling in schools for young people with emotional distress (ETHOS): study protocol for a randomised controlled trial

Background: One in ten children in Britain have been identified as experiencing a diagnosable mental health disorder. School-based humanistic counselling (SBHC) may help young people identify, address, and overcome psychological distress. Data from four pilot trials suggest that SBHC may be clinically effective. However, a fully powered randomised controlled trial (RCT) is needed to provide a robust test of its effectiveness, to assess its cost-effectiveness, and to determine the process of change. Methods/design: The Effectiveness and Cost-effectiveness Trial of Humanistic Counselling in Schools (ETHOS) is a two-arm, parallel-group RCT comparing the clinical and cost-effectiveness of SBHC with Pastoral Care as Usual (PCAU) in school settings. Eligibility criteria for young people include being between 13 and 16 years of age and experiencing moderate to severe levels of emotional distress. Participants are randomised to receive either SBHC or PCAU. SBHC is delivered in up to 10 weekly, individual sessions in their school with a qualified, experienced counsellor who has also received training using a clinical practice manual. Adherence to the SBHC model is assessed by a sub-team of auditors and in clinical supervision. PCAU consists of the schools’ pre-existing systems for supporting the emotional health and well-being of students. The primary outcomes are psychological distress measured using the Young Person’s Clinical Outcomes in Routine Evaluation (YP-CORE) and costs evaluated using the Client Service Receipt Inventory (CSRI). Secondary outcomes include psychological difficulties, levels of depression, anxiety and self-esteem, well-being, school engagement, educational outcomes and achievement of personal goals. Qualitative interviews with participants, parents and school staff will look to identify the mechanisms of change in SBHC. Researchers administering the measures are blind to allocation. The trial requires n = 306 participants (n = 153 in each group), with 90% power to detect a standardised mean difference (SMD) of 0.5. An intention-to-treat analysis will be undertaken. Discussion: This RCT is powered to detect clinically meaningful differences, and will make a major contribution to the evidence base for mental health provision for adolescents. It will have implications for all stakeholders, including policy-makers, statutory advisory bodies for child welfare, head teachers, children and young people practitioners, child welfare and parenting organisations, and young people. Trial registration: Controlled Trials International Standard Randomised Controlled Trial Number (ISRCTN) Registry, ID: ISRCTN10460622. Registered on 11 May 2016

Use and Cost of Hospital and Community Service Provision for Children with HIV Infection at an English HIV Referral Centre

Objective: To describe the use of hospital and community services for children infected with HIV and estimate the cost per patient-year by stage of HIV infection during the era of antiretroviral monotherapy. Design: Data on the use of hospital services were collected from case notes; the use of statutory and nonstatutory community services was recorded through diaries and interviews. Total cost estimates were calculated from unit costs from relevant hospital departments and community organisations. Setting: Children managed at St. Mary's Hospital (London, England) between 1 January 1986 and 31 December 1994, some of whom used statutory and nonstatutory community services in South East England between 1 November 1994 and 31 May 1996. Patients and participants: 118 children with positive HIV antibody status. Main outcome measures and results: Mean inpatient days, outpatient visits, tests and procedures performed, drugs prescribed, community services used, associated unit costs and average cost estimates per patient-year by stage of HIV infection (1995/1996 values), and lifetime costs. Service provision during the study period was predominantly hospital-based. The use of services increased for different stages of HIV infection and increased with increasing severity of HIV infection. A shift from an inpatient-based to an outpatient-based service was seen between the periods 1986 to 1991 and 1992 to 1994. As symptoms evolved, children used more hospital inpatient services, with an accompanying shift in the use of community services from general services, such as schooling, to increased use of nurses, social care and home help. The estimated total cost of hospital and community care was Lstg 18 600 per symptomatic non-AIDS patient per year and Lstg 46 600 per AIDS patient per year. Similar estimates for children with indeterminate HIV infection and asymptomatic infection amounted to Lstg 8300 and Lstg 4800 per patient-year, respectively. Nondiscounted lifetime costs for hospital care amounted to Lstg 152 400 (Lstg 44 300 to Lstg 266 800) compared with discounted lifetime costs of Lstg 122 700 (Lstg 42 000 to Lstg 182 200); nondiscounted lifetime costs for community care amounted to Lstg 24 300 (Lstg 7900 to Lstg 41600) compared with discounted lifetime costs of Lstg 21 000 (Lstg 6800 to Lstg 32 000). Conclusions: The continued emphasis on the use of hospital services may be due to the small number of children infected with HIV, most of whom lived in the London metropolitan area where specialist care was concentrated in a few centres. A shift from an inpatient- to an outpatient-based service was observed over time; the advent of the use of combination antiretroviral therapy in this population may further facilitate a shift in service provision and promote shared care between specialist centres, local hospitals and community-based services.Antivirals, Children, Cost analysis, HIV infections, Hospitalisation, Pharmacoeconomics

A preliminary investigation into the effectiveness of a group delivered sleep management intervention for parents of children with intellectual disabilities

Sleep problems are more prevalent and severe among children with intellectual disabilities and autism compared to typically developing children. Training parents in behavioural approaches to manage sleep problems is advocated. However, delivering such interventions via groups is novel. This article reports the findings from a preliminary evaluation of a group-delivered intervention routinely delivered by a Child and Adolescent Mental Health Service Learning Disability team in England. For this purpose, parents (n=23) of children with intellectual disabilities were recruited. The Children’s Sleep Habits Questionnaire, Parents’ Sense of Competence Scale and parent-set goals captured outcomes at pre-intervention, post-intervention and 3- and 6-month follow-up. Intervention delivery costs were collected. Take-up was high (86%), and no parent dropped out. Statistically significant improvements in night wakings, parent-set goals and parents’ sense of efficacy Sleep problems are more prevalent and severe among children with intellectual disabilities and autism compared to typically developing children. Training parents in behavioural approaches to manage sleep problems is advocated. However, delivering such interventions via groups is novel. This article reports the findings from a preliminary evaluation of a group-delivered intervention routinely delivered by a Child and Adolescent Mental Health Service Learning Disability team in England. For this purpose, parents (n=23) of children with intellectual disabilities were recruited. The Children’s Sleep Habits Questionnaire, Parents’ Sense of Competence Scale and parent-set goals captured outcomes at pre-intervention, post-intervention and 3- and 6-month follow-up. Intervention delivery costs were collected. Take-up was high (86%), and no parent dropped out. Statistically significant improvements in night wakings, parent-set goals and parents’ sense of efficacy were observed. The estimated mean cost of delivering each intervention was British (GBP) £1570. Findings suggest the intervention is a low-cost, acceptable service warranting further evaluatio

Additional file 1: of Effectiveness and cost-effectiveness of humanistic counselling in schools for young people with emotional distress (ETHOS): study protocol for a randomised controlled trial

SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (DOC 122 kb

Use and cost of hospital and community service provision for children with HIV infection at an English HIV referral centre

Objective: To describe the use of hospital and community services for children infected with HIV and estimate the cost per patient-year by stage of HIV infection during the era of antiretroviral monotherapy. Design: Data on the use of hospital services were collected from case notes; the use of statutory and nonstatutory community services was recorded through diaries and interviews. Total cost estimates were calculated from unit costs from relevant hospital departments and community organisations. Setting: Children managed at St. Mary’s Hospital (London, England) between 1 January 1986 and 31 December 1994, some of whom used statutory and nonstatutory community services in South East England between 1 November 1994 and 31 May 1996. Patients and participants: 118 children with positive HIV antibody status. Main outcome measures and results: Mean inpatient days, outpatient visits, tests and procedures performed, drugs prescribed, community services used, associated unit costs and average cost estimates per patient-year by stage of HIV infection (1995/1996 values), and lifetime costs. Service provision during the study period was predominantly hospital-based. The use of services increased for different stages of HIV infection and increased with increasing severity of HIV infection. A shift from an inpatient-based to an outpatient-based service was seen between the periods 1986 to 1991 and 1992 to 1994. As symptoms evolved, children used more hospital inpatient services, with an accompanying shift in the use of community services from general services, such as schooling, to increased use of nurses, social care and home help. The estimated total cost of hospital and community care was £18 600 per symptomatic non-AIDS patient per year and £46 600 per AIDS patient per year. Similar estimates for children with indeterminate HIV infection and asymptomatic infection amounted to £8300 and £4800 per patient-year, respectively. Nondiscounted lifetime costs for hospital care amounted to £152 400 (£44 300 to £266 800) compared with discounted lifetime costs of £122 700 (£42 000 to £182 200); nondiscounted lifetime costs for community care amounted to £24 300 (£7900 to £41600) compared with discounted lifetime costs of £21 000 (£6800 to £32 000). Conclusions: The continued emphasis on the use of hospital services may be due to the small number of children infected with HIV, most of whom lived in the London metropolitan area where specialist care was concentrated in a few centres. A shift from an inpatient- to an outpatient-based service was observed over time; the advent of the use of combination antiretroviral therapy in this population may further facilitate a shift in service provision and promote shared care between specialist centres, local hospitals and community-based services

The Use and Cost of HIV Service Provision in England in 1996

Objective: The aim of the study was to measure the use and estimate the cost of HIV service provision in England. Design and Setting: Standardised activity and case-severity data were collected prospectively in 10 English HIV clinics (5 London and 5 non-London sites) for the periods 1 January 1996 to 30 June 1996 and 1 July 1996 to 31 December 1996 and linked to unit cost data. In total, 5440 patients with HIV infection attended during the first 6 months and 5708 during the second 6 months in 1996. Main Outcome Measures and Results: The mean number of inpatient days per patient-year for patients with AIDS was 19.7 [95% confidence interval (CI): 13.7 to 25.7] for January to June and 20.8 (95% CI: 15.3 to 26.4) for July to December 1996. The mean number of outpatient visits for asymptomatic patients with HIV infection was 14.8 (95% CI: 11.9 to 17.6) and 13.3 (95% CI: 10.8 to 15.7) for the respective periods and 16.1 (95% CI: 13.21 to 18.97) and 15.7 (95% CI: 11.2 to 20.2), respectively, for patients with symptomatic non-AIDS (i.e. symptomatic patients with HIV infection but without AIDS-defining conditions). Substantial centre-to-centre variation was observed, suggesting that many clinics can continue the shift from an inpatient- to an outpatient-based service. Cost estimates per patient-year for HIV service provision for 1996 varied from Lstg 4695 (95% CI: Lstg 3769 to Lstg 5648) for asymptomatic patients, to Lstg 7605 (95% CI: Lstg 6273 to Lstg 8909) for symptomatic non-AIDS patients to Lstg 20 358 (95% CI: Lstg 17 681 to Lstg 23 206) for patients with AIDS. Conclusions: Different combinations of antiretroviral therapy affect the cost estimates of HIV service provision differently. Anticipated reduction in inpatient-related activity through the increased use of combination antiretroviral therapy will further shift service provision from an inpatient- to outpatient-based service and reduce costs per patient-year. The extent and duration of such effects are currently unknown. The long term effects of combination treatment on the morbidity and mortality patterns of individuals infected with HIV are also currently unknown, as are their implications on the use and cost of HIV service provision. Multicentre databases like the National Prospective Monitoring System (NPMS) will provide healthcare professionals with information to improve existing services and anticipate the impact of new developments.Pharmacoeconomics, Cost-analysis, HIV-infections, Antivirals, Hospitalisation, Resource-use, Zalcitabine, Zidovudine, Didanosine, Acquired-immunodeficiency-syndrome