Evaluation of intensive community care services for young people with psychiatric emergencies: study protocol for a multi-centre parallel-group, single-blinded randomized controlled trial with an internal pilot phase.

BACKGROUND: Over 3000 young people under the age of 18 are admitted to Tier 4 Child and Adolescent Mental Health Services (CAMHS) inpatient units across the UK each year. The average length of hospital stay for young people across all psychiatric units in the UK is 120 days. Research is needed to identify the most effective and efficient ways to care for young people (YP) with psychiatric emergencies. This study aims to evaluate the clinical effectiveness and cost-effectiveness of intensive community care service (ICCS) compared to treatment as usual (TAU) for young people with psychiatric emergencies. METHODS: This is a multicentre two-arm randomized controlled trial (RCT) with an internal pilot phase. Young people aged 12 to < 18 considered for admission at participating NHS organizations across the UK will be randomized 1:1 to either TAU or ICCS. The primary outcome is the time to return to or start education, employment, or training (EET) at 6 months post-randomization. Secondary outcomes will include evaluations of mental health and overall well-being and patient satisfaction. Service use and costs and cost-effectiveness will also be explored. Intention-to-treat analysis will be adopted. The trial is expected to be completed within 42 months, with an internal pilot phase in the first 12 months to assess the recruitment feasibility. A process evaluation using visual semi-structured interviews will be conducted with 42 young people and 42 healthcare workers. DISCUSSION: This trial is the first well-powered randomized controlled trial evaluating the clinical and cost-effectiveness of ICCS compared to TAU for young people with psychiatric emergencies in Great Britain. TRIAL REGISTRATION: ISRCTN ISRCTN42999542, Registration on April 29, 2020.

The Best Services Trial (BeST?): a cluster randomised controlled trial comparing the clinical and cost-effectiveness of New Orleans Intervention Model with services as usual (SAU) for infants and young children entering care.

BACKGROUND: Abused and neglected children are at increased risk of health problems throughout life, but negative effects may be ameliorated by nurturing family care. It is not known whether it is better to place these children permanently with substitute (foster or adoptive) families or to attempt to reform their birth families. Previously, we conducted a feasibility randomised controlled trial (RCT) of the New Orleans Intervention Model (NIM) for children aged 0-60 months coming into foster care in Glasgow. NIM is delivered by a multidisciplinary health and social care team and offers families, whose child has been taken into foster care, a structured assessment of family relationships followed by a trial of treatment aiming to improve family functioning. A recommendation is then made for the child to return home or for adoption. In the feasibility RCT, families were willing to be randomised to NIM or optimised social work services as usual and equipoise was maintained. Here we present the protocol of a substantive RCT of NIM including a new London site. METHODS: The study is a multi-site, pragmatic, single-blind, parallel group, cluster randomised controlled superiority trial with an allocation ratio of 1:1. We plan to recruit approximately 390 families across the sites, including those recruited in our feasibility RCT. They will be randomly allocated to NIM or optimised services as usual and followed up to 2.5 years post-randomisation. The principal outcome measure will be child mental health, and secondary outcomes will be child quality of life, the time taken for the child to be placed in permanent care (rehabilitation home or adoption) and the quality of the relationship with the primary caregiver. DISCUSSION: The study is novel in that infant mental health professionals rarely have a role in judicial decisions about children's care placements, and RCTs are rare in the judicial context. The trial will allow us to determine whether NIM is clinically and cost-effective in the UK and findings may have important implications for the use of mental health assessment and treatment as part of the decision-making about children in the care system.

Assessment of Somatosensory Function and Self-harm in Adolescents.

Importance: Self-harm is a risk factor for suicide in adolescents, with the prevalence highest in young people in group and residential care programs. Although no established risk factors for self-harm exist, adolescents who self-harm may have decreased pain sensitivity, but this has not been systematically investigated. Objective: To assess somatosensory function using quantitative sensory testing (QST) in children and adolescents living in care grouped by the number of episodes of self-harm in the past year and compare their somatosensory profiles with community control participants to investigate associations with the incidence or frequency of self-harm. Design, Setting, and Participants: Recruitment for this cross-sectional study began January 2019 and ended March 2020. Exclusion criteria included intellectual disability (intelligence quotient <70), autism spectrum disorder, or recent serious injury. Children and adolescents aged 12 to 17 years with no underlying health conditions were recruited from local authority residential care settings in Glasgow, UK, and schools and youth groups in London and Glasgow, UK. The volunteer sample of 64 participants included adolescents ages 13 to 17 years (34 [53%] females; 50 [78%] living in residential care; mean [SD] age, 16.34 [1.01] years) with varying incidents of self-harm in the past year (no episodes, 31 [48%]; 1-4 episodes, 12 [19%]; and ≥5 episodes, 2 [33%]). Exposures: Participants were tested using a standardized QST protocol to establish baseline somatosensory function. Main Outcomes and Measures: Associations between somatosensory sensitivity, incidence and frequency of self-harm, residential status, age, gender, and prescription medication were calculated. Secondary outcomes assessed whether self-harm was associated with specific types of tests (ie, painful or nonpainful). Results: A total of 64 participants ages 13 to 17 years completed testing (mean [SD] age, 16.3 [1.0] years; 34 [53%.] females and 30 [47%] males; 50 [78%] living in group homes). Adolescents with 5 or more self-harm incidences showed significant pain hyposensitivity compared with community control participants after adjusting for age, gender, and prescription drug use (SH group with 5 or more episodes vs control: -1.03 [95% CI, -1.47 to -0.60]; P < .001). Hyposensitivity also extended to nonpainful stimuli, similarly adjusted (SH group with 5 or more episodes vs control: -1.73; 95% CI, -2.62 to -0.84; P < .001). Pressure pain threshold accounted for most of the observed variance (31.1% [95% CI, 10.5% to 44.7%]; P < .001). Conclusions and Relevance: The findings of this study suggest that sensory hyposensitivity is a phenotype of Adolescents who self-harm and that pressure pain threshold has clinical potential as a quick, inexpensive, and easily interpreted test to identify adolescents at increased risk of repeated self-harm.

Supported discharge service versus inpatient care evaluation (SITE): a randomised controlled trial comparing effectiveness of an intensive community care service versus inpatient treatment as usual for adolescents with severe psychiatric disorders: self-harm, functional impairment, and educational and clinical outcomes.

Clinical guidelines recommend intensive community care service treatment (ICCS) to reduce adolescent psychiatric inpatient care. We have previously reported that the addition of ICCS led to a substantial decrease in hospital use and improved school re-integration. The aim of this study is to undertake a randomised controlled trial (RCT) comparing an inpatient admission followed by an early discharge supported by ICCS with usual inpatient admission (treatment as usual; TAU). In this paper, we report the impact of ICCS on self-harm and other clinical and educational outcomes. 106 patients aged 12-18 admitted for psychiatric inpatient care were randomised (1:1) to either ICCS or TAU. Six months after randomisation, we compared the two treatment arms on the number and severity of self-harm episodes, the functional impairment, severity of psychiatric symptoms, clinical improvement, reading and mathematical ability, weight, height and the use of psychological therapy and medication. At six-month follow-up, there were no differences between the two groups on most measures. Patients receiving ICCS were significantly less likely to report multiple episodes (five or more) of self-harm (OR = 0.18, 95% CI: 0.05-0.64). Patients admitted to private inpatient units spent on average 118.4 (95% CI: 28.2-208.6) fewer days in hospitals if they were in the ICCS group compared to TAU. The addition of ICCS to TAU may lower the risk of multiple self-harm and may reduce the duration of inpatient stay, especially in those patients admitted for private care. Early discharge with ICCS appears to be a viable alternative to standard inpatient treatment.

Specialized Therapeutic Assessment-Based Recovery-Focused Treatment for Young People With Self-Harm: Pilot Study.

Background: Suicide is the second leading cause of death in young people worldwide. Self-harm is the strongest predictor of death by suicide. There is increasing evidence that psychological therapies are efficacious in treating self-harm in adolescents. However, studies so far have predominantly focused on highly selective groups of adolescents and have investigated interventions that require intensive training and considerable expense. Methods: We conducted a pilot study of a novel psychological therapy package, Specialized Therapeutic Assessment-Based Recovery-Focused Treatment (START) that consists of Therapeutic Assessment followed by treatment in one of three modules, depending on adolescents' needs and preferences: Solution Focused Brief Therapy, Cognitive Behavior Therapy (CBT), or Mentalization Based Treatment. Adolescents (12-17) with at least one self-harm episode in the previous 6 months referred for community treatment, who had no intellectual disability, psychosis or autism were eligible for START. The primary outcome measure was the number of self-harm (regardless of suicidal intent) episodes 6 months before and 6 months after commencing START. Secondary outcomes included measures of psychopathology, functional impairment and family satisfaction. Results: Twenty-one consecutively referred adolescents were recruited and 15 received a therapeutic module of START: three received Solution Focused Brief Therapy, nine CBT, and three Mentalization Based Treatment. There was a statistically significant reduction in the number of self-harm episodes from a mean of 7.93 (SD = 12.26) to 1.00 (SD = 1.47), p < 0.02 following START. There was also a significant reduction in self-harm episodes, Revised Children's Anxiety and Depression Scale scores and a statistically significant improvement in Children Global Assessment Scale scores for the CBT group alone. There were no significant differences in any other outcomes. Most families were somewhat or very much satisfied with the intervention. Conclusion: The results show that START was associated with a reduction in self-harm and depression and anxiety symptoms, which could indicate that START should be rigorously studied in a randomized control trial (RCT). However, the model had difficulties in its implementation, with CBT being only module that was offered to enough young people to allow before and after analysis. CBT appears to be the most promising module in treating adolescents with self-harm referred to community mental health services.

Comparison of effectiveness and cost-effectiveness of an intensive community supported discharge service versus treatment as usual for adolescents with psychiatric emergencies: a randomised controlled trial.

BACKGROUND: Intensive community treatment to reduce dependency on adolescent psychiatric inpatient care is recommended in guidelines but has not been assessed in a randomised controlled trial in the UK. We designed a supported discharge service (SDS) provided by an intensive community treatment team and compared outcomes with usual care. METHODS: Eligible patients for this randomised controlled trial were younger than 18 years and had been admitted for psychiatric inpatient care in the South London and Maudsley NHS Foundation Trust. Patients were assigned 1:1 to either the SDS or to usual care by use of a computer-generated pseudorandom code with random permuted blocks of varying sizes. The primary outcome was number of inpatient bed-days, change in Strengths and Difficulties Questionnaire (SDQ) scores, and change in Children's Global Assessment Scale (CGAS) scores at 6 months, assessed by intention to treat. Cost-effectiveness was explored with acceptability curves based on CGAS scores and quality-adjusted life-years (QALYs) calculated from the three-level EuroQol measure of health-related quality of life (EQ-5D-3L), taking a health and social care perspective. This study is registered with the ISRCTN Registry, number ISRCTN82129964. FINDINGS: Hospital use at 6 months was significantly lower in the SDS group than in the usual care group (unadjusted median 34 IQR 17-63 vs 50 days, 19-125, p=0·04). The ratio of mean total inpatient days for usual care to SDS was 1·67 (95% CI 1·02-2·81, p=0·04), which decreased to 1·65 (0·99-2·77, p=0·057) when adjusted for differences in hospital use before randomisation. Scores for SDQ and CGAS did not differ between groups. The cost-effectiveness acceptability curve based on QALYs showed that the probability of SDS being cost-effective compared with usual care was around 60% with a willingness-to-pay threshold of £20 000-30 000 per QALY, and that based on CGAS showed at least 58% probability of SDS being cost-effective compared with usual care irrespective of willingness to pay. We recorded no adverse events attributable to SDS or usual care. INTERPRETATION: SDS provided by an intensive community treatment team reduced bed usage at 6 months' follow-up but had no effect on functional status and symptoms of mental health disorders compared with usual care. The possibility of preventing admissions, particularly through features such as reduced self-harm and improved reintegration into school, with intensive community treatment should be investigated in future studies. FUNDING: South London and Maudsley NHS Trust.

Randomised controlled trial of therapeutic assessment versus usual assessment in adolescents with self-harm: 2-year follow-up.

BACKGROUND: An earlier randomised controlled trial demonstrated improved treatment engagement in adolescents who received Therapeutic Assessment (TA) versus Assessment As Usual (AAU), following an emergency presentation with self-harm. OBJECTIVES: To determine 2-year outcomes for the same adolescents focusing on frequency of Accident and Emergency (A&E) self-harm presentations and treatment engagement. METHOD: Patients in the TA groups (n=35) and the AAU group (n=34) were followed up 2 years after the initial assessment. Their primary and secondary care electronic records were analysed. RESULTS: There was no significant difference in the frequency of self-harm resulting in A&E presentations between the two groups (OR 0.69, 95% CI 0.23 to 2.13, p=0.53). Treatment engagement remained higher in the TA group than the AAU group. CONCLUSIONS: TA is not associated with a lower frequency of A&E self-harm presentations. The effect of TA on engagement is maintained 2 years after the initial assessment. Interventions to reduce self-harm in adolescents are needed. TRIAL REGISTRATION: ISRCTN 81605131, http://www.controlled-trials.com/ISRCTN81605131/

Randomized trial comparing Internet-based training in cognitive behavioural therapy theory, assessment and formulation to delayed-training control.

OBJECTIVE: There is a need for effective, scalable methods of training clinicians in evidence-based interventions, particularly for populations with significant barriers to accessing traditional methods of training (e.g., developing economies, non-English speaking geographically dispersed populations). Hence this study examined the effectiveness of Internet-based training (IBT) in cognitive behavioural therapy (CBT) theory, assessment and formulation for participants in Russia with limited previous knowledge or training in CBT. METHOD: Participants (N = 63) were randomized to either immediate IBT (approximately three hours over the course of one month) or a delayed training control group. Participants were assessed immediately prior to and following the training/delay on (a) standardized role-play of a CBT assessment and (b) ability to construct CBT formulation of the role-play 'patient'. In addition the feasibility and acceptability of the training was assessed. RESULTS: Responses indicated that translated and subtitled IBT training was perceived by participants to be feasible and acceptable. Following the training those allocated to IBT scored significantly higher on measures of CBT assessment and formulation skills (between group effects sizes of d = 0.77-1.10) than those allocated to the control group. Participants reported IBT to be a feasible and acceptable form of CBT dissemination. An adaptation of the CTS used to rate a standardized role-play assessment demonstrated good inter-rater reliability. CONCLUSIONS: IBT may be an effective and scalable method of CBT dissemination with particular potential for training CBT skills in populations with significant barrier to accessing traditional methods of training.

Teaching therapeutic assessment for self-harm in adolescents: training outcomes.

OBJECTIVES: To describe the teaching programme of Therapeutic Assessment (TA), a brief intervention at the point of initial assessment for adolescents with self-harm; to describe trainees' preferences and choices regarding their use of specific aspects of TA. DESIGN: This is a comparative study investigating the differences in the TA skills before and after training. This design was chosen to establish whether or not TA training is efficacious. METHODS: Twenty-four clinicians volunteered to participate in five half-day TA training sessions. Their scores on the Therapeutic Assessment Quality Assurance Tool (TAQAT, primary outcome measure) were compared before and after training. Satisfaction with training and therapeutic strategy choices as well as ability to perform TA in an RCT were investigated. RESULTS: Clinicians who participated in TA training had significantly increased scores on TAQAT after training. The clinicians who achieved the required quality of TA post assessments were likely to be able to carry out TA in an RCT with high fidelity. In addition, prior to training, significant differences in the quality of assessments as measured by TAQAT were identified depending on the experience of the clinician. This discrepancy was no longer present post training. Therapeutic strategy based on solution-focused brief therapy (SFBT) was the option of choice post training. CONCLUSIONS: TA training is feasible and associated with improved quality of self-harm assessment. PRACTITIONER POINTS: TA is a brief intervention associated with improved treatment engagement. TA training is feasible and is associated with improved quality of self-harm assessment. SFBT-based exit is the most commonly used strategy in TA.

Adolescents with suicidal and nonsuicidal self-harm: clinical characteristics and response to therapeutic assessment.

Self-harm is one of the best predictors of death by suicide, but few studies directly compare adolescents with suicidal versus nonsuicidal self-harm. Seventy adolescents presenting with self-harm (71% young women, ages 12-18 years) who participated in a randomized controlled trial were divided into suicidal and nonsuicidal self-harm categories using the Columbia Classification Algorithm of Suicide Assessment. Adolescents with suicidal self-harm were more likely than those with nonsuicidal self-harm to be young women, 22/23 (96%) versus 34/47 (72%), odds ratio (OR) = 8.33, 95% confidence interval (CI) [1.03, 50.0]; had a later age of onset of self-harm, 15.4 years vs. 13.8 years, mean difference = 1.6, 95% CI [.8, 2.43]; and used self-poisoning more often, 18/23 (78%) versus 11/47 (23%), OR = 3.43, 95% CI [2.00, 5.89]. Only those with nonsuicidal self-harm had an improvement on Children's Global Assessment Scale score following a brief therapeutic intervention, mean difference = 8.20, 95% CI [.97, 15.42]. However, there was no interaction between treatment and suicidality. There are important differences between adolescents presenting with suicidal and nonsuicidal self-harm. Suicidal self-harm in adolescence may be associated with a less favorable response to therapeutic assessment.

Trial of Therapeutic Assessment in London: randomised controlled trial of Therapeutic Assessment versus standard psychosocial assessment in adolescents presenting with self-harm.

OBJECTIVE: To determine whether Therapeutic Assessment (TA) versus assessment as usual (AAU) improves engagement with follow-up in adolescents presenting with self-harm. DESIGN: Randomised controlled trial with 3 months naturalistic follow-up. SETTING: Child and adolescent mental health services in two London National Health Service Trusts. PARTICIPANTS: 26 clinicians randomised into TA and AAU groups recruited 70 newly referred adolescents with self-harm. INTERVENTIONS: TA, a manualised procedure including a basic psychosocial assessment and a 30 min therapeutic intervention; AAU, standard psychosocial assessment. MAIN OUTCOME MEASURES: Attendance at the first follow-up session; number of the follow-up sessions attended and changes in Strengths and Difficulties Questionnaire and Children's Global Assessment Scale scores. All measures were adjusted for clustering, social class, changes of therapist and previous contact with services. RESULTS: Using the data on all participants (n=70), those in the TA group were significantly more likely to attend the first follow-up appointment: 29 (83%) versus 17 (49%), OR 5.12, 95% CI (1.49 to 17.55) and more likely to attend four or more treatment sessions: 14 (40%) versus 4 (11%), OR 5.19, 95% CI (2.22 to 12.10). Three months after the initial assessment there were no statistically significant differences between the groups on Strengths and Difficulties Questionnaire scores: 15.6 versus 16.0, mean difference -0.37, 95% CI (-3.28 to 2.53) or Children's Global Assessment Scale scores: 64.6 versus 60.1, mean difference 4.49, 95% CI (-0.98 to 9.96). CONCLUSIONS: TA was associated with statistically significant improvement in engagement. TA could be usefully applied at the point of initial assessment for adolescents with self-harm. TRIAL REGISTRATION: ISRCTN 81605131 http://www.controlled-trials.com/ISRCTN81605131/.

Delivering psychiatric services in primary care: is this the right way to go for Ukraine?

Ukraine is a newly independent state with a population of about 48 million. It inherited its national health system from the USSR. The Soviet system was conceived as part of a massively expensive socialist planning economy that was generally delivering poor value for money. Some aspects of the Soviet health system were, however, undoubtedly sound and certain public health measures were superior to those in the West. For example, infant mortality, despite possible underreporting, was probably lower in the USSR than in many Western countries (Anderson & Silver, 1986). The health system became increasingly corrupt and inefficient during the final years of the USSR's existence. Since independence, the health system has not been a state priority and has been chronically under-funded. In the past few years of rapid economic development in Ukraine, the share of the state budget allocated to the health system has remained static, leaving Ukraine in a disadvantaged state compared with other European countries (United Nations, 2007).