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Background Randomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018. Methods We followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010. Results The CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention. Conclusions Authors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.

Background The CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently. Methods Following a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84%) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram. Results CONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting. Conclusions The CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website ( www.consort-statement.org ) are helpful resources for improving the reporting of social and psychological intervention RCTs.

ObjectivesThis study aimed to estimate the incidence of DSM5 anorexia nervosa in young people in contact with child and adolescent mental health services in the UK and Ireland.DesignObservational, surveillance study, using the Child and Adolescent Psychiatry Surveillance System, involving monthly reporting by child and adolescent psychiatrists between 1st February 2015 and 30th September 2015.SettingThe study was based in the UK and Ireland.ParticipantsClinician-reported data on young people aged 8–17 in contact with child and adolescent mental health services for a first episode of anorexia nervosa.Main outcome measuresAnnual incidence rates (IRs) estimated as confirmed new cases per 100 000 population at risk.Results305 incident cases of anorexia nervosa were reported over the 8-month surveillance period and assessed as eligible for inclusion. The majority were young women (91%), from England (70%) and of white ethnicity (92%). Mean age was 14.6 years (±1.66) and mean percentage of median expected body mass index for age and sex was 83.23% (±10.99%). The overall IR, adjusted for missing data, was estimated to be 13.68 per 100 000 population (95% CI 12.88 to 14.52), with rates of 25.66 (95% CI 24.09 to 27.30) for young women and 2.28 (95% CI 1.84 to 2.79) for young men. Incidence increased steadily with age, peaking at 15 (57.77, 95% CI 50.41 to 65.90) for young women and 16 (5.14, 95% CI 3.20 to 7.83) for young men. Comparison with earlier estimates suggests IRs for children aged 12 and under have increased over the last 10 years.ConclusionThese results provide new estimates of the incidence of anorexia nervosa in young people. Service providers and commissioners should consider evidence to suggest an increase in incidence in younger children.Trial registration number ISRCTN12676087.

Behaviour problems are common in young children with autism spectrum disorder (ASD). There are many different tools used to measure behavior problems but little is known about their validity for the population. To evaluate the measurement properties of behaviour problems tools used in evaluation of intervention or observational research studies with children with ASD up to the age of six years. Behaviour measurement tools were identified as part of a larger, two stage, systematic review. First, sixteen major electronic databases, as well as grey literature and research registers were searched, and tools used listed and categorized. Second, using methodological filters, we searched for articles examining the measurement properties of the tools in use with young children with ASD in ERIC, MEDLINE, EMBASE, CINAHL, and PsycINFO. The quality of these papers was then evaluated using the COSMIN checklist. We identified twelve tools which had been used to measure behaviour problems in young children with ASD, and fifteen studies which investigated the measurement properties of six of these tools. There was no evidence available for the remaining six tools. Two questionnaires were found to be the most robust in their measurement properties, the Child Behavior Checklist and the Home Situations Questionnaire-Pervasive Developmental Disorders version. We found patchy evidence on reliability and validity, for only a few of the tools used to measure behaviour problems in young children with ASD. More systematic research is required on measurement properties of tools for use in this population, in particular to establish responsiveness to change which is essential in measurement of outcomes of intervention. CRD42012002223.

Background The Republic of Malawi is creating a country-wide system of 28 One-Stop Centres (known as ‘Chikwanekwanes’ - ‘everything under one roof’) to provide medical, legal and psychosocial services for survivors of child maltreatment and adult intimate partner violence. No formal evaluation of the utility of such services has ever been undertaken. This study focused on the experiences of the families served at the country’s first Chikwanekwane in the large, urban city of Blantyre. Methods One hundred seven families were surveyed in their home three months after their initial evaluation for sexual abuse at the Blantyre One Stop Centre, and 25 families received a longer interview. The survey was designed to inquire what types of initial evaluation and follow-up services the children received from the medical, legal and social welfare services. Results All 107 received an initial medical exam and HIV testing, and 83% received a follow-up HIV test by 3 months; 80.2% were seen by a social welfare worker on the initial visit, and 29% had a home visit by 3 months; 84% were seen by a therapist at the initial visit, and 12% returned for further treatment; 95.3% had an initial police report and 27.1% ended in a criminal conviction for child sexual abuse. Most of the families were satisfied with the service they received, but a quarter of the families were not satisfied with the law enforcement response, and 2% were not happy with the medical assessment. Conclusions: Although a perception of corruption or negligence by police may discourage use of service, we believe that the One-Stop model is an appropriate means to deliver high quality care to survivors of abuse in Malawi.

Background Relative to their counterparts in the general population, young people who leave, or transition out of, out-of-home (OOHC) arrangements commonly experience poorer outcomes across a range of indicators, including higher rates of homelessness, unemployment, reliance on public assistance, physical and mental health problems and contact with the criminal justice system. The age at which young people transition from OOHC varies between and within some countries, but for most, formal support ceases between the ages of 18 and 21. Programs designed to support transitions are generally available to young people toward the end of their OOHC placement, although some can extend beyond. They often encourage the development of skills required for continued engagement in education, obtaining employment, maintaining housing and general life skills. Little is known about the effectiveness of these programs or of extended care policies that raise the age at which support remains available to young people after leaving OOHC. This systematic review will seek to identify programs and/or interventions that improve outcomes for youth transitioning from the OOHC system into adult living arrangements. Methods This review will identify programs, interventions and policies that seek to improve health and wellbeing of this population that have been tested using robust controlled methods. Primary outcomes of interest are homelessness, health, education, employment, exposure to violence and risky behaviour. Secondary outcomes are relationships and life skills. We will search, from January 1990 onwards, MEDLINE, EMBASE, PsycINFO, ERIC, CINAHL, Cochrane CENTRAL, SocINDEX, Sociological Abstracts, Social Services Abstracts, NHS Economic Evaluation Database and Health Technology Assessment. Grey literature will be identified through searching websites and databases, e.g. clearing houses, government agencies and organisations known to be undertaking or consolidating research on this topic area. Two reviewers will independently screen all title and abstracts and full text articles with conflicts to be resolved by a third reviewer. Data extraction will be undertaken by pairs of review authors, with one reviewer checking the results of the other. If more than one study with suitable data can be identified, we plan to undertake both fixed-effects and random-effects meta-analyses and intend to present the random-effects result if there is no indication of funnel plot asymmetry. Risk of bias will be assessed using tools appropriate to the study methodology. Quality of evidence across studies will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) methodology. Discussion Previous reviews were unable to identify any programs or interventions, backed by methodologically rigorous research, that improve outcomes for this population. This review seeks to update this previous work, taking into account changes in the provision of extended care, which is now available in some jurisdictions. Systematic review registration PROSPERO CRD42020146999

Background Child maltreatment is a significant public health problem. Group Family Nurse Partnership (gFNP) is a new intervention for young, expectant mothers implemented successfully in pilot studies. This study was designed to determine the effectiveness and cost-effectiveness of gFNP in reducing risk factors for maltreatment with a potentially vulnerable population. Methods A multi-site, randomized controlled, parallel-arm trial and prospective economic evaluation was conducted, with allocation via remote randomization (minimization by site, maternal age group) to gFNP or usual care. Participants were expectant mothers aged below 20 years with at least one live birth, or aged 20–24 years with no live births and with low educational qualifications. Data from maternal interviews at baseline and when infants were 2, 6 and 12 months, and video-recording at 12 months, were collected by researchers blind to allocation. Cost information came from weekly logs completed by gFNP family nurses and other service delivery data reported by participants. Primary outcomes measured at 12 months were parenting attitudes (Adult-Adolescent Parenting Index, AAPI-2) and maternal sensitivity (CARE Index). The economic evaluation was conducted from a UK NHS and personal social services perspective with cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. The main analyses were intention-to-treat with additional complier average causal effects (CACE) analyses. Results Between August 2013 and September 2014, 492 names of potential participants were received of whom 319 were eligible and 166 agreed to take part, 99 randomly assigned to receive gFNP and 67 to usual care. There were no between-arm differences in AAPI-2 total (7 · 5/10 in both, SE 0.1), difference adjusted for baseline, site and maternal age group 0 · 06 (95% CI − 0 · 15 to 0 · 28, p  = 0 · 59) or CARE Index (intervention 4 · 0 (SE 0 · 3); control 4 · 7 (SE 0 · 4); difference adjusted for site and maternal age group − 0 · 68 (95% CI − 1 · 62 to 0 · 16, p  = 0 · 25) scores. The probability that gFNP is cost-effective based on the QALY measure did not exceed 3%. Conclusions The trial did not support gFNP as a means of reducing the risk of child maltreatment in this population but slow recruitment adversely affected group size and consequently delivery of the intervention. Trial registration ISRCTN78814904 . Registered on 17 May 2013.

Background Evidence suggests specialist eating disorders services for children and adolescents with anorexia nervosa have the potential to improve outcomes and reduce costs through reduced hospital admissions. This study aimed to evaluate the cost-effectiveness of assessment and diagnosis in community-based specialist child and adolescent mental health services (CAMHS) compared to generic CAMHS for children and adolescents with anorexia nervosa. Method Observational, surveillance study of children and adolescents aged 8 to 17, in contact with community-based CAMHS in the UK or Republic of Ireland for a first episode of anorexia nervosa. Data were reported by clinicians at baseline, 6 and 12-months follow-up. Outcomes included the Children’s Global Assessment Scale (CGAS) and percentage of median expected body mass for age and sex (%mBMI). Service use data included paediatric and psychiatric inpatient admissions, outpatient and day-patient attendances. A joint distribution of incremental mean costs and effects for each group was generated using bootstrapping to explore the probability that each service is the optimal choice, subject to a range of values a decision-maker might be willing to pay for outcome improvements. Uncertainty was explored using cost-effectiveness acceptability curves. Results Two hundred ninety-eight children and adolescents met inclusion criteria. At 12-month follow-up, there were no significant differences in total costs or outcomes between specialist eating disorders services and generic CAMHS. However, adjustment for pre-specified baseline covariates resulted in observed differences favouring specialist services, due to significantly poorer clinical status of the specialist group at baseline. Cost-effectiveness analysis using CGAS suggests that the probability of assessment in a specialist service being cost-effective compared to generic CAMHS ranges from 90 to 50%, dependent on willingness to pay for improvements in outcome. Conclusions Assessment in a specialist eating disorders service for children and adolescents with anorexia nervosa may have a higher probability of being cost-effective than assessment in generic CAMHS. Trial registration ISRCTN12676087 . Date of registration 07/01/2014. Plain English summary Specialist eating disorders services may improve outcomes and reduce hospitalisations for children and adolescents with anorexia nervosa. Reductions in hospitalisation could save money for the NHS and are better for young people because hospitalisation disrupts their home life, social life and education. This study evaluated outcomes and costs of specialist eating disorders services compared to general child and adolescent mental health services (CAMHS) for children and adolescents with anorexia nervosa. Children and adolescents were identified by contacting child and adolescent psychiatrists in the UK and Ireland and asking them to report any new cases of anorexia nervosa. These psychiatrists identified 298 young people aged 8 to 17 with an anorexia nervosa diagnosis for the first time. The psychiatrists provided information on the health services these young people used and how they were doing when they were first diagnosed and 6 months and 1 year later. Children and adolescents in specialist services were more severely ill than those in CAMHS when they were first diagnosed. Despite this, care for the young people in specialist services cost about the same as for those diagnosed in CAMHS, and their outcomes after 1 year were similar. This work showed that specialist services may be better value for money than CAMHS.

Background Children born to mothers who experience social complexity (e.g. substance misuse, intimate partner violence, mental ill health, a history of maltreatment) are at increased risk for a range of adverse outcomes at birth and during development. Home visiting programmes have been advocated as a strategy for improving outcomes for disadvantaged mothers and children, such as the Nurse-Family Partnership for young, socially disadvantaged first-time mothers. However, no evidence-based programme is available for multiparous women or older first-time mothers. The New Baby Programme was developed in Northern Ireland. It augments the universal health visiting service available in the UK with a content designed to promote maternal health and well-being in pregnancy, maximise secure attachments of children and parents and enhance sensitive parenting and infant cognitive development. Methods/Design This pilot study is designed to investigate whether it is possible to recruit and retain socially vulnerable mothers in a randomised trial that compares the effects of the New Baby Programme with standard antenatal and postnatal care. Feasibility issues include the referral/recruitment pathway (including inclusion and exclusion criteria), the consent and randomisation, the ability to maintain researcher blinding, the acceptability of the intervention to participants, and the feasibility and acceptability of the outcome measures. The results of the study will inform a definitive phase-3 RCT. Discussion Trials of complex social interventions often encounter challenges that lead to the trial being abandoned (e.g. because of problems in recruitment) or present considerable analytic challenges relating to dropout, attrition and bias. This pilot study aims to maximise the chances of successful implementation. Trial registration ISRCTN35456296 retrospectively registered

Background Rights-based approaches for conducting research with children and young people are now widely accepted by those working in the field. Such approaches focus on the voice of the child and are underpinned by a firm recognition that children are experts on their own lives. However, children and young people with disabilities are less likely to take part in research. Aim To draw on doctoral research conducted with children and young people with disabilities to explore the ethical issues that arose concerning access, recruitment, consent, anonymity, confidentiality and sensitive issues, as well as what mitigated these issues. Discussion Research with children and young people with disabilities can pose additional ethical challenges. There is a growing body of literature about this area, but it needs further development. Conclusion Additional planning and preparation are vital in ensuring that children and young people with disabilities can participate in research in a meaningful way and that researchers conduct studies ethically. Implications for practice This paper has clear implications for research and nursing practice in terms of communicating with children and young people with disabilities, enabling them to express their views and participate in decisions about their lives.