Service design for children and young people with common mental health problems: literature review, service mapping and collective case study.

Background: The mental health of children/young people is a growing concern internationally. Numerous reports and reviews have consistently described United Kingdom children's mental health services as fragmented, variable, inaccessible and lacking an evidence base. Little is known about the effectiveness of, and implementation complexities associated with, service models for children/young people experiencing 'common' mental health problems like anxiety, depression, attention deficit hyperactivity disorder and self-harm. Aim: To develop a model for high-quality service design for children/young people experiencing common mental health problems by identifying available services, barriers and enablers to access, and the effectiveness, cost effectiveness and acceptability of such services. Design: Evidence syntheses with primary research, using a sequential, mixed-methods design. Inter-related scoping and integrative reviews were conducted alongside a map of relevant services across England and Wales, followed by a collective case study of English and Welsh services. Setting: Global (systematic reviews); England and Wales (service map; case study). Data sources: Literature reviews: relevant bibliographic databases and grey literature. Service map: online survey and offline desk research. Case study: 108 participants (41 children/young people, 26 parents, 41 staff) across nine case study sites. Methods: A single literature search informed both reviews. The service map was obtained from an online survey and internet searches. Case study sites were sampled from the service map; because of coronavirus disease 2019, case study data were collected remotely. 'Young co-researchers' assisted with case study data collection. The integrative review and case study data were synthesised using the 'weaving' approach of 'integration through narrative'. Results: A service model typology was derived from the scoping review. The integrative review found effectiveness evidence for collaborative care, outreach approaches, brief intervention services and the 'availability, responsiveness and continuity' framework. There was cost-effectiveness evidence only for collaborative care. No service model appeared to be more acceptable than others. The service map identified 154 English and Welsh services. Three themes emerged from the case study data: 'pathways to support'; 'service engagement'; and 'learning and understanding'. The integrative review and case study data were synthesised into a coproduced model of high-quality service provision for children/young people experiencing common mental health problems. Limitations: Defining 'service model' was a challenge. Some service initiatives were too new to have filtered through into the literature or service map. Coronavirus disease 2019 brought about a surge in remote/digital services which were under-represented in the literature. A dearth of relevant studies meant few cost-effectiveness conclusions could be drawn. Conclusions: There was no strong evidence to suggest any existing service model was better than another. Instead, we developed a coproduced, evidence-based model that incorporates the fundamental components necessary for high-quality children's mental health services and which has utility for policy, practice and research. Future work: Future work should focus on: the potential of our model to assist in designing, delivering and auditing children's mental health services; reasons for non-engagement in services; the cost effectiveness of different approaches in children's mental health; the advantages/disadvantages of digital/remote platforms in delivering services; understanding how and what the statutory sector might learn from the non-statutory sector regarding choice, personalisation and flexibility. Study registration: This study is registered as PROSPERO CRD42018106219. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 17/09/08) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 13. See the NIHR Funding and Awards website for further award information.

In this research study, we explored services for children and young people with 'common' mental health problems like depression, anxiety and self-harm. We aimed to find out what services exist, how children/young people and families find out about and access these services, what the services actually do, whether they are helpful and whether they offer value for money. We looked at the international literature (reports and research papers) to identify different approaches to providing support, and to find out whether certain approaches worked better than others and whether children/young people and families preferred some approaches over others. The literature provided very little information about the value for money of services. We also carried out a survey and used the internet to identify 154 relevant services in England and Wales. To explore services in more detail, and hear directly from those using them, we planned to visit 9 of the 154 services to interview children/young people, parents and staff. Unfortunately, coronavirus disease 2019 stopped us directly visiting the nine services and so we conducted phone and video interviews instead. We still managed to speak to, and hear the experiences of, more than 100 people (including children/young people and parents). We combined information from the literature with information from the interviews to create an evidence-based 'model' of what services should look like. This model considers some basic things like how quickly children/young people could access a service, what information was available, the importance of confidentiality and whether staff make the service fit with the child/young person's needs and interests. It also considers whether the service helps children/young people learn skills to manage their mental health and whether staff at a service work well together. We hope our model will help existing and new services improve what they offer to children/young people and families.

Development and evaluation of a de-escalation training intervention in adult acute and forensic units: the EDITION systematic review and feasibility trial.

Background: Containment (e.g. physical restraint and seclusion) is used frequently in mental health inpatient settings. Containment is associated with serious psychological and physical harms. De-escalation (psychosocial techniques to manage distress without containment) is recommended to manage aggression and other unsafe behaviours, for example self-harm. All National Health Service staff are trained in de-escalation but there is little to no evidence supporting training's effectiveness. Objectives: Objectives were to: (1) qualitatively investigate de-escalation and identify barriers and facilitators to use across the range of adult acute and forensic mental health inpatient settings; (2) co-produce with relevant stakeholders an intervention to enhance de-escalation across these settings; (3) evaluate the intervention's preliminary effect on rates of conflict (e.g. violence, self-harm) and containment (e.g. seclusion and physical restraint) and understand barriers and facilitators to intervention effects. Design: Intervention development informed by Experience-based Co-design and uncontrolled pre and post feasibility evaluation. Systematic reviews and qualitative interviews investigated contextual variation in use and effects of de-escalation. Synthesis of this evidence informed co-design of an intervention to enhance de-escalation. An uncontrolled feasibility trial of the intervention followed. Clinical outcome data were collected over 24 weeks including an 8-week pre-intervention phase, an 8-week embedding and an 8-week post-intervention phase. Setting: Ten inpatient wards (including acute, psychiatric intensive care, low, medium and high secure forensic) in two United Kingdom mental health trusts. Participants: In-patients, clinical staff, managers, carers/relatives and training staff in the target settings. Interventions: Enhancing de-escalation techniques in adult acute and forensic units: Development and evaluation of an evidence-based training intervention (EDITION) interventions included de-escalation training, two novel models of reflective practice, post-incident debriefing and feedback on clinical practice, collaborative prescribing and ward rounds, practice changes around admission, shift handovers and the social and physical environment, and sensory modulation and support planning to reduce patient distress. Main outcome measures: Outcomes measured related to feasibility (recruitment and retention, completion of outcome measures), training outcomes and clinical and safety outcomes. Conflict and containment rates were measured via the Patient-Staff Conflict Checklist. Clinical outcomes were measured using the Attitudes to Containment Measures Questionnaire, Attitudes to Personality Disorder Questionnaire, Violence Prevention Climate Scale, Capabilities, Opportunities, and Motivation Scale, Coercion Experience Scale and Perceived Expressed Emotion in Staff Scale. Results: Completion rates of the proposed primary outcome were very good at 68% overall (excluding remote data collection), which increased to 76% (excluding remote data collection) in the post-intervention period. Secondary outcomes had high completion rates for both staff and patient respondents. Regression analyses indicated that reductions in conflict and containment were both predicted by study phase (pre, embedding, post intervention). There were no adverse events or serious adverse events related to the intervention. Conclusions: Intervention and data-collection procedures were feasible, and there was a signal of an effect on the proposed primary outcome. Limitations: Uncontrolled design and self-selecting sample. Future work: Definitive trial determining intervention effects. Trial registration: This trial is registered as ISRCTN12826685 (closed to recruitment). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/101/02) and is published in full in Health Technology Assessment; Vol. 28, No. 3. See the NIHR Funding and Awards website for further award information. Context: Conflict (a term used to describe a range of potentially unsafe events including violence, self-harm, rule-breaking, medication refusal, illicit drug and alcohol use and absconding) in mental health settings causes serious physical and psychological harm. Containment interventions which are intended to minimise harm from violence (and other conflict behaviours) such as restraint, seclusion and rapid tranquilisation can result in serious injuries to patients and, occasionally, death. Involvement in physical restraint is the most common cause of serious physical injury to National Health Service mental health staff in the United Kingdom. Violence to staff results in substantial costs to the health service in sickness and litigation payments. Containment interventions are also expensive (e.g. physical restraint costs mental health services £6.1 million and enhanced observations £88 million per annum). Despite these harms, recent findings indicate containment interventions such as seclusion and physical restraint continue to be used frequently in mental health settings. Clinical trials have demonstrated that interventions can reduce containment without increasing violence and other conflict behaviours (e.g. verbal aggression, self-harm). Substantial cost-savings result from reducing containment use. De-escalation, as an intervention to manage aggression and potential violence without restrictive practices, is a core intervention. 'De-escalation' is a collective term for a range of psychosocial techniques designed to reduce distress and anger without the need to use 'containment' interventions (measures to prevent harm through restricting a person's ability to act independently, such as physical restraint and seclusion). Evidence indicates that de-escalation involves ensuring conditions for safe intervention and effective communication are established, clarifying and attempting to resolve the patient's concern, conveyance of respect and empathy and regulating unhelpful emotions such as anxiety and anger. Despite featuring prominently in clinical guidelines and training policy domestically and internationally and being a component of mandatory National Health Service training, there is no evidence-based model on which to base training. A systematic review of de-escalation training effectiveness and acceptability conducted in 2015 concluded: (1) no model of training has demonstrated effectiveness in a sufficiently rigorous evaluation, (2) the theoretical underpinning of evaluated models was often unclear and (3) there has been inadequate investigation of the characteristics of training likely to enhance acceptability and uptake. Despite all National Health Service staff being trained in de-escalation there have been no high-quality trials evaluating the effectiveness and cost-effectiveness of training. Feasibility studies are needed to establish whether it is possible to conduct a definitive trial that can determine the clinical, safety and cost-effectiveness of this intervention.

Mental health hospitals are stressful places for patients and staff. Patients are often detained against their will, in places that are noisy, unfamiliar and frightening. Violence and self-injury happen quite frequently. Sometimes staff physically restrain patients or isolate patients in locked rooms (called seclusion). While these measures might sometimes be necessary to maintain safety, they are psychologically and physically harmful. To help reduce the use of these unsafe measures, staff are trained in communication skills designed to reduce anger and distress without using physical force. Professionals call these skills 'de-escalation'. Although training in de-escalation is mandatory, there is no good evidence to say whether it works or not, or what specific techniques staff should be trained in. The Enhancing de-escalation techniques in adult acute and forensic units: Development and evaluation of an evidence-based training intervention (EDITION) project aimed to develop and evaluate a de-escalation training programme informed by research evidence. We interviewed over one hundred people who either worked in or received treatment in a mental health hospital. These people were clear that the training should target key sources of interpersonal and environmental stress that prevent de-escalation from working. We also reviewed all the scientific studies on de-escalation and training, aiming to identify the elements of training that are most likely to increase use of de-escalation. Then, in partnership with current mental health service users and clinical staff, we developed the training programme. Training was delivered to more than 270 staff working in 10 different wards in mental health hospitals. We measured rates of violence, self-injury and use of physical restraint and seclusion 8 weeks before staff received training and 16 weeks after they received training (24 weeks of data collection in total). Analysis of these data showed that these unsafe events were occurring significantly less frequently after training than they were before training, which raised the possibility that the training was helping to reduce harm.

Exploring the use of social network interventions for adults with mental health difficulties: a systematic review and narrative synthesis.

BACKGROUND: People with mental health difficulties often experience social isolation. The importance of interventions to enhance social networks and reduce this isolation is increasingly being recognised. However, the literature has not yet been systematically reviewed with regards to how these are best used. This narrative synthesis aimed to investigate the role of social network interventions for people with mental health difficulties and identify barriers and facilitators to effective delivery. This was undertaken with a view to understanding how social network interventions might work best in the mental health field. METHODS: Systematic searches using combinations of synonyms for mental health difficulties and social network interventions were undertaken across 7 databases (MEDLINE, Embase, PsycINFO, CINAHL, Cochrane Library, Web of Science) and 2 grey literature databases (EThoS and OpenGrey) from their inception to October 2021. We included studies reporting primary qualitative and quantitative data from all study types relating to the use of social network interventions for people with mental health difficulties. The quality of included studies was assessed using the Mixed Methods Appraisal Tool. Data were extracted and synthesised narratively. RESULTS: The review included 54 studies, reporting data from 6,249 participants. Social network interventions were generally beneficial for people with mental health difficulties but heterogeneity in intervention type, implementation and evaluation made it difficult to draw definitive conclusions. Interventions worked best when they (1) were personalised to individual needs, interests and health, (2) were delivered outside formal health services and (3) provided the opportunity to engage in authentic valued activities. Several barriers to access were identified which, without careful consideration could exacerbate existing health inequalities. Further research is required to fully understand condition-specific barriers which may limit access to, and efficacy of, interventions. CONCLUSIONS: Strategies for improving social networks for people with mental health difficulties should focus on supporting engagement with personalised and supported social activities outside of formal mental health services. To optimise access and uptake, accessibility barriers should be carefully considered within implementation contexts and equality, diversity and inclusion should be prioritised in intervention design, delivery and evaluation and in future research.

One session treatment (OST) is equivalent to multi-session cognitive behavioral therapy (CBT) in children with specific phobias (ASPECT): results from a national non-inferiority randomized controlled trial.

BACKGROUND: 5%-10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non-inferiority of OST compared to multi-session CBT for treating specific phobias in CYP. METHODS: ASPECT was a pragmatic, multi-center, non-inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university-based CYP well-being service. CYP aged 7-16 years with specific phobia were randomized to receive OST or CBT. Clinical non-inferiority and a nested cost-effectiveness evaluation was assessed 6-months post-randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal-based outcome measure, and EQ-5DY and CHU-9D, collected blind at baseline and six-months. RESULTS: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention-to-treat (ITT) and per-protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale-adjusted mean difference for CBT compared to OST -0.123, 95% CI -0.449 to 0.202 (ITT), mean difference -0.204, 95% CI -0.579 to 0.171 (PP)). These findings were wholly below the standardized non-inferiority limit of 0.4, suggesting that OST is non-inferior to CBT. No between-group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. CONCLUSIONS: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost-saving alternative.

One-session treatment compared with multisession CBT in children aged 7-16 years with specific phobias: the ASPECT non-inferiority RCT.

BACKGROUND: Up to 10% of children and young people have a specific phobia that can significantly affect their mental health, development and daily functioning. Cognitive-behavioural therapy-based interventions remain the dominant treatment, but limitations to their provision warrant investigation into low-intensity alternatives. One-session treatment is one such alternative that shares cognitive-behavioural therapy principles but has a shorter treatment period. OBJECTIVE: This research investigated the non-inferiority of one-session treatment to cognitive-behavioural therapy for treating specific phobias in children and young people. The acceptability and cost-effectiveness of one-session treatment were examined. DESIGN: A pragmatic, multicentre, non-inferiority randomised controlled trial, with embedded economic and qualitative evaluations. SETTINGS: There were 26 sites, including 12 NHS trusts. PARTICIPANTS: Participants were aged 7-16 years and had a specific phobia defined in accordance with established international clinical criteria. INTERVENTIONS: Participants were randomised 1 : 1 to receive one-session treatment or usual-care cognitive-behavioural therapy, and were stratified according to age and phobia severity. Outcome assessors remained blind to treatment allocation. MAIN OUTCOME MEASURES: The primary outcome measure was the Behavioural Avoidance Task at 6 months' follow-up. Secondary outcomes included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety and Depression Scale, a goal-based outcome measure, Child Health Utility 9D, EuroQol-5 Dimensions Youth version and resource usage. Treatment fidelity was assessed using the Cognitive Behaviour Therapy Scale for Children and Young People and the One-Session Treatment Rating Scale. RESULTS: A total of 274 participants were recruited, with 268 participants randomised to one-session treatment (n = 134) or cognitive-behavioural therapy (n = 134). A total of 197 participants contributed some data, with 149 participants in the intention-to-treat analysis and 113 in the per-protocol analysis. Mean Behavioural Avoidance Task scores at 6 months were similar across treatment groups when both intention-to-treat and per-protocol analyses were applied [cognitive-behavioural therapy: 7.1 (intention to treat), 7.4 (per protocol); one-session treatment: 7.4 (intention to treat), 7.6 (per protocol); on the standardised scale adjusted mean difference for cognitive-behavioural therapy compared with one-session treatment -0.123, 95% confidence interval -0.449 to 0.202 (intention to treat), mean difference -0.204, 95% confidence interval -0.579 to 0.171 (per protocol)]. These findings were wholly below the standardised non-inferiority limit of 0.4, which suggests that one-session treatment is non-inferior to cognitive-behavioural therapy. No between-group differences in secondary outcome measures were found. The health economics evaluation suggested that, compared with cognitive-behavioural therapy, one-session treatment marginally decreased the mean service use costs and maintained similar mean quality-adjusted life-year improvement. Nested qualitative evaluation found one-session treatment to be considered acceptable by those who received it, their parents/guardians and clinicians. No adverse events occurred as a result of phobia treatment. LIMITATIONS: The COVID-19 pandemic meant that 48 children and young people could not complete the primary outcome measure. Service waiting times resulted in some participants not starting therapy before follow-up. CONCLUSIONS: One-session treatment for specific phobia in UK-based child mental health treatment centres is as clinically effective as multisession cognitive-behavioural therapy and highly likely to be cost-saving. Future work could involve improving the implementation of one-session treatment through training and commissioning of improved care pathways. TRIAL REGISTRATION: This trial is registered as ISRCTN19883421. FUNDING: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 42. See the NIHR Journals Library website for further project information.

A phobia is an intense, ongoing fear of an everyday object or situation. The phobia causes distress and the person with the phobia avoids that object or situation. Many children and young people have phobias that affect their daily lives. Cognitive­behavioural therapy helps by changing what people do or think when they have a phobia and is the most common treatment approach. However, cognitive­behavioural therapy is expensive, takes time and is not always easy to get. Different treatments are needed to help children and young people with specific phobias. One such therapy is one-session treatment, which works in similar ways to cognitive­behavioural therapy but takes place over one main 3-hour session. Our study, called ASPECT (Alleviating Specific Phobias Experienced by Children Trial), compared these two treatments to examine whether or not one-session treatment is as effective as cognitive­behavioural therapy. Overall, 274 children and young people aged 7­16 years from 26 sites nationally helped with our research, of whom 268 received either cognitive­behavioural therapy or one-session treatment. The results at 6 months found that one-session treatment and cognitive­behavioural therapy worked as well as each other for treating phobias in children and young people. We also found evidence that one-session treatment is cheaper than cognitive­behavioural therapy. We spoke with children and young people, their parents/guardians and the therapists of the single-session treatment, and we found one-session treatment to be acceptable for their needs. Future research could explore how to make one-session treatment more easily available for children and young people with specific phobias because it can save time and money, and works just as well as cognitive­behavioural therapy.

Parity of esteem and systems thinking: a theory informed qualitative inductive thematic analysis.

BACKGROUND: Parity of Esteem (PoE) is about equality between mental and physical health but is a term lacking definition and clarity. The complexity of the field of mental health and the conversations around PoE add to its opacity. Therefore, the aim of this study is to use systems thinking to explore the strengths and challenges of using PoE. METHODS: This is a secondary analysis of descriptive qualitative data, from 27 qualitative interviews, utilising the World Health Organisation (WHO) system domains as a framework for the inductive thematic analysis. RESULTS: Examining the current strengths and challenges of systems in mental and physical healthcare using the WHO domains and macro, meso and micro levels, identifies specific actions to redress inequity between mental and physical health provision. CONCLUSION: The evidence suggests that moving PoE from rhetoric towards reality requires new configurations with a systems orientation, which uses macro, meso and micro levels to analyse and understand the complexity of relations within and between domain levels and reorienting funding, training and measurement. This requires embedding new competencies, infrastructures and practices within an effective learning healthcare system.

REACH-ASD: a UK randomised controlled trial of a new post-diagnostic psycho-education and acceptance and commitment therapy programme against treatment-as-usual for improving the mental health and adjustment of caregivers of children recently diagnosed with autism spectrum disorder.

BACKGROUND: Autism is a neurodevelopmental disability affecting over 1% of UK children. The period following a child's autism diagnosis can present real challenges in adaptation for families. Twenty to 50% of caregivers show clinically significant levels of mental health need within the post-diagnostic period and on an ongoing basis. Best practice guidelines recommend timely post-diagnostic family support. Current provision is patchy, largely unevidenced, and a source of dissatisfaction for both families and professionals. There is a pressing need for an evidenced programme of post-diagnostic support focusing on caregiver mental health and adjustment, alongside autism psycho-education. This trial tests the clinical and cost-effectiveness of a new brief manualised psychosocial intervention designed to address this gap. METHODS: This is a multi-centre two-parallel-group single (researcher)-blinded randomised controlled trial of the Empower-Autism programme plus treatment-as-usual versus usual local post-diagnostic offer plus treatment-as-usual. Caregivers of children aged 2-15 years with a recent autism diagnosis will be recruited from North West England NHS or local authority centres. Randomisation is individually by child, with one "index" caregiver per child, stratified by centre, using 2:1 randomisation ratio to assist recruitment and timely intervention. Empower-Autism is a group-based, manualised, post-diagnostic programme that combines autism psycho-education and psychotherapeutic components based on Acceptance and Commitment Therapy to support caregiver mental health, stress management and adjustment to their child's diagnosis. The comparator is any usual local group-based post-diagnostic psycho-education offer. Receipt of services will be specified through health economic data. PRIMARY OUTCOME: caregiver mental health (General Health Questionnaire-30) at 52-week follow-up. SECONDARY OUTCOMES: key caregiver measures (wellbeing, self-efficacy, adjustment, autism knowledge) at 12-, 26- and 52-week follow-up and family and child outcomes (wellbeing and functioning) at 52-week endpoint. SAMPLE: N=380 (approximately 253 intervention/127 treatment-as-usual). Primary analysis will follow intention-to-treat principles using linear mixed models with random intercepts for group membership and repeated measures. Cost-effectiveness acceptability analyses will be over 52 weeks, with decision modelling to extrapolate to longer time periods. DISCUSSION: If effective, this new approach will fill a key gap in the provision of evidence-based care pathways for autistic children and their families. TRIAL REGISTRATION: ISRCTN 45412843 . Prospectively registered on 11 September 2019.

Using routine outcome measures as clinical process tools: Maximising the therapeutic yield in the IAPT programme when working remotely.

OBJECTIVES: The objective of the study was to investigate the administration and use of routine outcome monitoring session by session in the context of improving guided-self-help interventions when delivered remotely at Step 2 care in the English Improving Access to Psychological Therapies (IAPT) services. DESIGN: Qualitative research using recordings of telephone-treatment sessions. METHOD: Participants (11 patients and 11 practitioners) were recruited from four nationally funded IAPT services and one-third sector organisation commissioned to deliver Step 2 IAPT services, in England. Data collection took place prior to the COVID-19 pandemic. Transcripts of telephone-treatment sessions were analysed using thematic analysis. RESULTS: Four themes were identified: (1) lack of consistency in the administration of outcome measures (e.g. inconsistent wording); (2) outcome measures administered as a stand-alone inflexible task (e.g. mechanical administration); (3) outcome measures as impersonal numbers (e.g. summarising, categorising and comparing total scores); and (4) missed opportunities to use outcome measures therapeutically (e.g. lack of therapeutic use of item and total scores). CONCLUSIONS: The administration of outcome measures needs to ensure validity and reliability. Therapeutic yield from session-by-session outcome measures could be enhanced by focusing on three main areas: (1) adopting a collaborative conversational approach, (2) maximising the use of total and items scores and (3) integrating outcome measures with in-session treatment decisions. Shifting the perception of outcome measures as impersonal numbers to being process clinical tools ensures a personalised delivery of psychological interventions and has the potential to enhance engagement from practitioners and patients what may reduce drop-out rates and improve clinical outcomes.

Assessing the effectiveness of social network interventions for adults with a diagnosis of mental health problems: a systematic review and narrative synthesis of impact.

BACKGROUND: Social connections have been linked to the genesis and amelioration of mental health problems and thus have potential therapeutic value. PURPOSE: To identify the current evidence base, assess risk of bias and synthesise findings on the effectiveness of social network interventions for people with mental health problems. METHODS: Electronic databases (MEDLINE, Embase, PsycINFO, CINAHL, Cochrane Library, Web of Science, Scopus) and grey literature databases were systematically searched from inception to October 2021 using free text syntax combining synonyms for 'mental health problems' and 'social network interventions'. Articles were eligible for inclusion if they reported data from randomised controlled trials on the effectiveness of interventions designed to improve social networks for adults (18+) with mental health problems. Papers were independently reviewed for inclusion with conflicts resolved through consensus. Included papers were quality assessed and data extracted and synthesized narratively. Risk of bias was assessed using the Cochrane Risk of Bias Tool. RESULTS: Nine studies randomising 2226 participants were included. Four focused on those with a diagnosis of schizophrenia or psychosis, one on major depressive disorder and four included all types of mental health diagnoses. The current evidence base is of unclear quality. However, interventions which focused on supporting social activities appear to hold the most promise for enhancing social networks. Data on cost-effectiveness and research acceptability were limited, but suggest the potential economic feasibility of and acceptability for evaluating these interventions. CONCLUSION: There is emerging evidence that social network interventions can be effective in improving social connections for people with mental health problems. However, further evaluations with robust methodological approaches are required to inform evidence-based recommendations for health services.

Out of pocket expenses in obsessive compulsive disorder.

BACKGROUND: Despite anecdotal evidence that the out of pocket costs of OCD can be substantial in some cases, there is no evidence on how many people they affect, or the magnitude of these costs. AIMS: This paper explores the type and quantity of out of pocket expenses reported by a large sample of adults with OCD. METHODS: Data on out of pocket expenses were collected from participants taking part in the OCTET multi-centre randomised controlled trial. Participants were aged 18+, meeting DSM-IV criteria for OCD, and scoring 16+ on the Yale Brown Obsessive Compulsive Scale. Individual-level resource use data including a description and estimated cost of out of pocket expenses were measured using an adapted version of the Adult Service Use Schedule (AD-SUS): a questionnaire used to collect data on resource use. RESULTS: Forty-five percent (208/465) reported out of pocket expenses due to their OCD. The mean cost of out of pocket expenses was £19.19 per week (SD £27.56 SD), range £0.06-£224.00. CONCLUSIONS: Future economic evaluations involving participants with OCD should include out of pocket expenses, but careful consideration of alternative approaches to the collection and costing of this data is needed.

Enhancing the Behaviour Change Wheel with synthesis, stakeholder involvement and decision-making: a case example using the 'Enhancing the Quality of Psychological Interventions Delivered by Telephone' (EQUITy) research programme.

BACKGROUND: Using frameworks such as the Behaviour Change Wheel to develop behaviour change interventions can be challenging because judgement is needed at various points in the process and it is not always clear how uncertainties can be resolved. We propose a transparent and systematic three-phase process to transition from a research evidence base to a behaviour change intervention. The three phases entail evidence synthesis, stakeholder involvement and decision-making. We present the systematic development of an intervention to enhance the quality of psychological treatment delivered by telephone, as a worked example of this process. METHOD: In phase 1 (evidence synthesis), we propose that the capabilities (C), opportunities (O) and motivations (M) model of behaviour change (COM-B) can be used to support the synthesis of a varied corpus of empirical evidence and to identify domains to be included in a proposed behaviour change intervention. In phase 2 (stakeholder involvement), we propose that formal consensus procedures (e.g. the RAND Health/University of California-Los Angeles Appropriateness Methodology) can be used to facilitate discussions of proposed domains with stakeholder groups. In phase 3 (decision-making), we propose that behavioural scientists identify (with public/patient input) intervention functions and behaviour change techniques using the acceptability, practicability, effectiveness/cost-effectiveness, affordability, safety/side-effects and equity (APEASE) criteria. RESULTS: The COM-B model was a useful tool that allowed a multidisciplinary research team, many of whom had no prior knowledge of behavioural science, to synthesise effectively a varied corpus of evidence (phase 1: evidence synthesis). The RAND Health/University of California-Los Angeles Appropriateness Methodology provided a transparent means of involving stakeholders (patients, practitioners and key informants in the present example), a structured way in which they could identify which of 93 domains identified in phase 1 were essential for inclusion in the intervention (phase 2: stakeholder involvement). Phase 3 (decision-making) was able to draw on existing Behaviour Change Wheel resources to revisit phases 1 and 2 and facilitate agreement among behavioural scientists on the final intervention modules. Behaviour changes were required at service, practitioner, patient and community levels. CONCLUSION: Frameworks offer a foundation for intervention development but require additional elucidation at each stage of the process. The decisions adopted in this study are designed to provide an example on how to resolve challenges while designing a behaviour change intervention. We propose a three-phase process, which represents a transparent and systematic framework for developing behaviour change interventions in any setting.

'So just to go through the options ': patient choice in the telephone delivery of the NHS Improving Access to Psychological Therapies services.

This article considers patient choice in mental healthcare services, specifically the ways that choice is enabled or constrained in patient-practitioner spoken interaction. Using the method of conversation analysis (CA), we examine the language used by practitioners when presenting treatment delivery options to patients entering the NHS Improving Access to Psychological Therapies (IAPT) service. Analysis of 66 recordings of telephone-delivered IAPT assessment sessions revealed three patterns through which choice of treatment delivery mode was presented to patients: presenting a single delivery mode; incrementally presenting alternative delivery modes, in response to patient resistance; and parallel presentation of multiple delivery mode options. We show that a distinction should be made between (i) a choice to accept or reject the offer of a single option and (ii) a choice that is a selection from a range of options. We show that the three patterns identified are ordered in terms of patient-centredness and shared decision-making. Our findings contribute to sociological work on healthcare interactions that has identified variability in, and variable consequences for, the ways that patients and practitioners negotiate choice and shared decision-making. Findings are discussed in relation to tensions between the political ideology of patient choice and practical service delivery constraints.

An intervention to improve the quality of life in children of parents with serious mental illness: the Young SMILES feasibility RCT.

BACKGROUND: Quality of life for children and adolescents living with serious parental mental illness can be impaired, but evidence-based interventions to improve it are scarce. OBJECTIVE: Co-production of a child-centred intervention [called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES)] to improve the health-related quality of life of children and adolescents living with serious parental mental illness, and evaluating its acceptability and feasibility for delivery in NHS and community settings. DESIGN: Qualitative and co-production methods informed the development of the intervention (Phase I). A feasibility randomised controlled trial was designed to compare Young SMILES with treatment as usual (Phase II). Semistructured qualitative interviews were used to explore acceptability among children and adolescents living with their parents, who had serious mental illness, and their parents. A mixture of semistructured qualitative interviews and focus group research was used to examine feasibility among Young SMILES facilitators and referrers/non-referrers. SETTING: Randomisation was conducted after baseline measures were collected by the study co-ordinator, ensuring that the blinding of the statistician and research team was maintained to reduce detection bias. PARTICIPANTS: Phase I: 14 children and adolescents living with serious parental mental illness, seven parents and 31 practitioners from social, educational and health-related sectors. Phase II: 40 children and adolescents living with serious parental mental illness, 33 parents, five referrers/non-referrers and 16 Young SMILES facilitators. INTERVENTION: Young SMILES was delivered at two sites: (1) Warrington, supported by the National Society for the Prevention of Cruelty to Children (NSPCC), and (2) Newcastle, supported by the NHS and Barnardo's. An eight-session weekly group programme was delivered, with four to six children and adolescents living with serious parental mental illness per age-appropriate group (6-11 and 12-16 years). At week 4, a five-session parallel weekly programme was offered to the parents/carers. Sessions lasted 2 hours each and focused on improving mental health literacy, child-parent communication and children's problem-solving skills. MAIN OUTCOME MEASURES: Phase ll children and parents completed questionnaires at randomisation and then again at 4 and 6 months post randomisation. Quality of life was self-reported by children and proxy-reported by parents using the Paediatric Quality of Life questionnaire and KIDSCREEN. Semistructured interviews with parents (n = 14) and children (n = 17) who participated in the Young SMILES groups gathered information about their motivation to sign up to the study, their experiences of participating in the group sessions, and their perceived changes in themselves and their family members following intervention. Further interviews with individual referrers (n = 5) gathered information about challenges to recruitment and randomisation. Two focus groups (n = 16) with practitioners who facilitated the intervention explored their views of the format and content of the Young SMILES manual and their suggestions for changes. RESULTS: A total of 35 families were recruited: 20 were randomly allocated to Young SMILES group and 15 to treatment as usual. Of those, 28 families [15/20 (75%) in the intervention group and 13/15 (87%) in the control group] gave follow-up data at the primary end point (4 months post baseline). Participating children had high adherence to the intervention and high completion rates of the questionnaires. Children and adolescents living with their parents, who had serious mental illness, and their parents were mainly very positive and enthusiastic about Young SMILES, both of whom invoked the benefits of peer support and insight into parental difficulties. Although facilitators regarded Young SMILES as a meaningful and distinctive intervention having great potential, referrers identified several barriers to referring families to the study. One harm was reported by a parent, which was dealt with by the research team and the NSPCC in accordance with the standard operating procedures. LIMITATIONS: The findings from our feasibility study are not sufficient to recommend a fully powered trial of Young SMILES in the near future. Although it was feasible to randomise children and adolescents living with serious parental mental illness of different ages to standardised, time-limited groups in both NHS and non-NHS settings, an intervention like Young SMILES is unlikely to address underlying core components of the vulnerability that children and adolescents living with serious parental mental illness express as a population over time. CONCLUSIONS: Young SMILES was widely valued as unique in filling a recognised gap in need. Outcome measures in future studies of interventions for children and adolescents living with serious parental mental illness are more likely to capture change in individual risk factors for reduced quality of life by considering their unmet need, rather than on an aggregate construct of health-related quality of life overall, which may not reflect these young people's needs. FUTURE WORK: A public health approach to intervention might be best. Most children and adolescents living with serious parental mental illness remain well most of the time, so, although their absolute risks are low across outcomes (and most will remain resilient most of the time), consistent population estimates find their relative risk to be high compared with unexposed children. A public health approach to intervention needs to be both tailored to the particular needs of children and adolescents living with serious parental mental illness and agile to these needs so that it can respond to fluctuations over time. TRIAL REGISTRATION: Current Controlled Trials ISRCTN36865046. FUNDING: This project was funded by the National Institute of Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 59. See the NIHR Journals Library website for further project information.

Children and adolescents living with serious parental mental illness are at increased risk of poorer mental, physical and emotional health but few services are available to them. We worked with young people, parents and professionals to co-develop a community-based intervention called Young Simplifying Mental Illness plus Life Enhancement Skills (SMILES). This involves eight children's sessions over 8 weeks in two age groups (6­11 and 12­16 years) and five separate parent sessions. Each session includes activities designed to improve understanding of mental illness, communication between children and parents, and problem-solving. To assess the feasibility and how acceptable Young SMILES is to those who received (and delivered) the intervention, we recruited 35 families: 20 were offered Young SMILES and 15 continued to receive their usual care. Children and parents completed questionnaires when they entered the research and then after 4 and 6 months. Children and adolescents living with serious parental mental illness assigned to either Young SMILES or usual-care groups reported that their quality of life, mental health, day-to-day functioning and knowledge of mental illness was similar to that of their population peers. Answers to parental questionnaires suggested that overall our participants' parenting style was positive and their levels of stress were as expected for parents in general. Across questionnaires, parents underestimated their children's quality of life and overestimated their difficulties. Children and adolescents living with serious parental mental illness and parents were mainly very positive and enthusiastic about Young SMILES. They liked getting together to discuss their experiences with others in similar situations, but some parents felt unprepared to do this. Children liked having something that focused on their own needs separately from those of their parents; they liked the fun activities and valued the time away from their parents, but also wanted their parents to have support. Facilitators and referrers saw great value in Young SMILES. The needs of children with mentally ill parents remain unmet in the current system; a future evaluation of Young SMILES needs to reconsider the primary outcome and start with a pilot trial with clear criteria for progression to a full trial.

Influence of Needs and Experiences of Haemato-Oncology Patients on Acceptability of a Telephone Intervention for Support and Symptom Management: A Qualitative Study.

Healthcare technologies are increasingly used to address the unmet needs of patients with cancer; however new service developments must be acceptable to patients. The objective of this study was to determine the unmet needs of haemato-oncology patients and their influence on the perceived acceptability and participation in a telephone intervention delivering. A qualitative study was designed interviewing 20 participants having received the intervention. Data were analysed inductively and deductively using Framework Analysis. Three core themes emerged: (1) fluctuations in emotional distress and coping across the cancer trajectory with evidence of adaptive and maladaptive coping; (2) potential deficits in patient support, continuity of care and information provision; and (3) intervention acceptability analysis underpinned by the Theoretical Framework of Acceptability showed acceptability was influenced by participants' subjective illness contexts and unmet needs.This work contributes to understanding of personal context as a determinant of intervention acceptability in order to enhance implementation strategies.

A case of misalignment: the perspectives of local and national decision-makers on the implementation of psychological treatment by telephone in the Improving Access to Psychological Therapies Service.

BACKGROUND: Psychological treatment delivered by telephone is recommended by the National Institute for Health and Care Excellence (NICE) for mild to moderate depression and anxiety, and forms a key part of the Improving Access to Psychological Therapy (IAPT) programme in the UK. Despite evidence of clinical effectiveness, patient engagement is often not maintained and psychological wellbeing practitioners (PWPs) report lacking confidence and training to deliver treatment by telephone. This study aimed to explore the perspectives of professional decision makers (both local and national) on the barriers and facilitators to the implementation of telephone treatment in IAPT. METHODS: Sixteen semi-structured qualitative telephone interviews and one focus group were carried out with decision makers (n = 21) who were involved locally and nationally in policy, practice and research. The interviews and focus group were coded thematically, and then mapped onto the four core constructs of Normalisation Process Theory (NPT). RESULTS: The use of telephone for psychological treatment was universally recognised amongst participants as beneficial for improving patient choice and access to treatment. However, at service level, motives for the implementation of telephone treatments are often misaligned with national objectives. Pressure to meet performance targets has become a key driver for the use of telephone treatment, with promises of increased efficiency and cost savings. These service-focussed objectives challenge the integration of telephone treatments, and PWP acceptance of telephone treatments as non-inferior to face-to-face. Ambivalence among a workforce often lacking the confidence to deliver telephone treatments leads to reluctance among PWPs to 'sell' treatments to a patient population who are not generally expecting treatment in this form. CONCLUSIONS: Perceptions of a need to 'sell' telephone treatment in IAPT persist from top-level decision makers down to frontline practitioners, despite their conflicting motives for the use of telephone. The need for advocacy to highlight the clinical benefit of telephone treatment, along with adequate workforce support and guidance on best practice for implementation is critical to the ongoing success and sustainability of telephone treatment in primary care mental health programmes.

Impact of telephone delivered case-management on the effectiveness of collaborative care for depression and anti-depressant use: A systematic review and meta-regression.

BACKGROUND: The health service delivery framework collaborative care is an effective intervention for depression. However, uncertainties remain about how to optimise its delivery at scale. Structured case management is a core component of collaborative care; its delivery via the telephone may improve access. AIMS: To examine using meta-regression if telephone delivered case management diminishes the clinical effectiveness of collaborative care on depressive symptoms and anti-depressant use relative to face-to-face delivery methods. METHODS: Randomised controlled trials were eligible if they included collaborative care interventions for adults with depression identified using self-report measures or diagnostic interviews and reported depression outcomes. Sociodemographics, intervention characteristics, depressive symptoms, and anti-depressant use were extracted. Random effects univariable and multivariable meta-regression analyses were used to examine the moderating effect of telephone delivered case-management on outcomes. RESULTS: Ninety-four trials were identified comprising of 103 comparisons across 24, 132 participants with depression outcomes and 67 comparisons from 15,367 participants with anti-depressant use outcomes. Telephone delivered case management did not diminish the effects of collaborative care on depressive symptoms (ß = -0.01, 95% CI -0.12 to 0.10; p = 0.86). Telephone delivered case management decreased anti-depressant medication use (relative risk 0.76, 95% CI 0.63 to 0.92; p = 0.005); this effect remained when assessed simultaneously alongside other study-level moderators of collaborative care. CONCLUSION: Using remote platforms such as the telephone to deliver case management may be a feasible way to implement collaborative care with no loss of effectiveness on depressive symptoms. However, adherence to anti-depressant medication may decrease when telephone case management is used.

Enhancing maternal and infant wellbeing: study protocol for a feasibility trial of the Baby Triple P Positive Parenting programme for mothers with severe mental health difficulties (the IMAGINE study).

BACKGROUND: There is a strong evidence base for the benefits of parenting interventions for parents without severe mental illness (SMI). As the impact of maternal SMI can be significant on child development, mothers need support to maximise outcomes for themselves and their children. Some mothers with SMI require admission jointly with their baby to a Mother and Baby Unit (MBU), a psychiatric inpatient ward, for assessment and treatment. However, MBUs do not yet offer formally evaluated, evidence-based parenting interventions as a matter of routine. This paper describes a study to investigate the feasibility and acceptability of conducting a randomised controlled trial (RCT) to evaluate a parenting and psychological intervention targeting the mother's and infant's wellbeing for mothers admitted to a MBU. METHODS/DESIGN: This study is a multisite, single-blind feasibility trial with half the participants randomised to the Baby Triple P Positive Parenting Programme plus treatment as usual (TAU) and the other half randomised to TAU alone. Self-report and observer-rated assessments are collected at baseline, 10 weeks post-baseline and 6 months post-baseline. Participants are mothers admitted to a MBU in the Northwest of England or the Midlands. Participants are included if they are fluent in English to provide informed, written consent. Our objective is to determine whether we can recruit 66 women, randomise 60, and retain them in the intervention and study, and whether the intervention and study procedures are acceptable. As part of a nested process evaluation, qualitative interview data from trial participants and MBU staff will inform feasibility and acceptability. The feasibility of collecting data required to conduct an economic evaluation of the intervention will also be explored. DISCUSSION: Although research has been conducted in relation to mothers with severe mental illness and MBUs, to our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake and retention alongside the potential efficacy of a parenting intervention for this population. This study is essential to examine the contextual challenges involved in this setting with this population and to identify any refinements required. TRIAL REGISTRATION: ISRCTN12765736 . Date of first registration: 2 February 2017.

Clinical and cost-effectiveness of one-session treatment (OST) versus multisession cognitive-behavioural therapy (CBT) for specific phobias in children: protocol for a non-inferiority randomised controlled trial.

INTRODUCTION: Specific phobias (intense, enduring fears of an object or situation that lead to avoidance and severe distress) are highly prevalent among children and young people. Cognitive-behavioural therapy (CBT) is a well-established, effective intervention, but it can be time consuming and costly because it is routinely delivered over multiple sessions during several months. Alternative methods of treating severe and debilitating phobias in children are needed, like one-session treatment (OST), to reduce time and cost, and to prevent therapeutic drift and help children recover quickly. Our study explores whether (1) outcomes with OST are 'no worse' than outcomes with multisession CBT, (2) OST is acceptable to children, their parents and the practitioners who use it and (3) OST offers good value for money to the National Health Service (NHS) and to society. METHOD: A pragmatic, non-inferiority, randomised controlled trial will compare OST with multisession CBT-based therapy on their clinical and cost-effectiveness. The primary clinical outcome is a standardised behavioural task of approaching the feared stimulus at 6 months postrandomisation. The outcomes for the within-trial cost-effectiveness analysis are quality-adjusted life years based on EQ-5D-Y, and individual-level costs based of the intervention and use of health and social service care. A nested qualitative evaluation will explore children's, parents' and practitioners' perceptions and experiences of OST. A total of 286 children, 7-16 years old, with DSM-IV diagnoses of specific phobia will be recruited via gatekeepers in the NHS, schools and voluntary youth services, and via public adverts. ETHICS AND DISSEMINATION: The trial received ethical approval from North East and York Research Ethics Committee (Reference: 17/NE/0012). Dissemination plans include publications in peer-reviewed journals, presentations in relevant research conferences, local research symposia and seminars for children and their families, and for professionals and service managers. TRIAL REGISTRATION NUMBER: ISRCTN19883421;Pre-results.

Collaborative, individualised lifestyle interventions are acceptable to people with first episode psychosis; a qualitative study.

BACKGROUND: The adverse impact of unhealthy lifestyle choices and the prescription of antipsychotic medications contribute to weight gain, poor cardiovascular health and reduced life expectancy for people with psychosis. The present study aimed to explore the acceptability and perceived outcomes of a lifestyle intervention designed to prevent or reduce weight gain in people with first-episode psychosis. METHODS: This was a qualitative study using a data-driven approach. People recovering from first-episode psychosis recruited from UK early intervention services and taking part in the active arm of a randomised controlled trial of a lifestyle intervention (the InterACT trial), were interviewed using a semi-structured interview schedule. Interviews were transcribed verbatim and analysed using Framework Analysis. RESULTS: Participants valued the collaborative and individualised approach taken by the intervention deliverers, and formed high quality relationships with them. Aspects of the intervention that were positively appraised included goal setting, social opportunities, and progress monitoring. Benefits of the intervention, including increased levels of exercise; improved diet and physical health; increased psychological wellbeing (e.g. confidence, self-esteem); and improved social relationships, were identified by participants, independent of actual weight loss. CONCLUSIONS: Future interventions should ensure that workers have the skills to form high quality relationships with users, and to individualise the intervention according to users' needs and preferences. Future trials that test healthy living interventions should consider supplementing physical outcome measures with wider psychosocial outcome assessments, in particular social relationship quality, psychological wellbeing, self-esteem and self-efficacy. TRIAL REGISTRATION: Current Controlled Trials: ISRCTN22581937 . Date of registration: 27 October 2010 (retrospectively registered).

Exploring service users', carers' and professionals' perspectives and experiences of current antipsychotic prescribing: A qualitative study.

Objectives Shared decision-making is the pinnacle of patient-centred care; mental health stakeholders value shared decision-making but find it difficult to enact. The objective was to compare and synthesise mental health stakeholder views on antipsychotic prescribing in one NHS Trust, to understand potential reasons for the difficult enactment of shared decision-making in practice. Methods We conducted 12 interviews and 5 focus groups with 33 mental health stakeholders, after obtaining their informed consent. They shared their experiences in and perceptions of antipsychotic prescribing and were recruited from Manchester Mental Health and Social Care Trust. Results Stakeholders agreed that successful shared decision-making demands a collaborative approach. We elucidated a striking divergence in views of the decision-making process and understanding of collaboration. Nurses, consultants and the pharmacist seemed most satisfied with the amount of collaboration but most pessimistic about the scope for it. Carers and most service users did not feel that there was any collaboration. Discussion Comparison of perspectives demonstrated the complexity of shared decision-making which is not addressed in current operational definitions or policy or nursing practice initiatives. The findings have the potential to progress initiatives in the mental health field from those that emphasise the need for shared decision-making to those that develop tools to promote shared decision-making.