Systematic Review and Meta-Analysis of Policies and Interventions that Improve Health, Psychosocial, and Economic Outcomes for Young People Leaving the Out-of-Home Care System.

Young people who transition to adulthood from out-of-home care (OOHC) are more likely to experience a range of poorer outcomes relative to their same-age peers in the community. This systematic review assessed the effectiveness of policies or interventions (hereafter "interventions") aimed at improving housing, health, education, economic, and psychosocial outcomes for youth leaving OOHC (hereafter "care leavers"). Eleven databases of published literature were reviewed along with gray literature. Eligible studies used randomized or quasi-experimental designs and assessed interventions that provided support to care leavers prior to, during, or after they left OOHC. Primary outcomes were housing and homelessness, health and well-being, education, economic and employment, criminal and delinquent behavior, and risky behavior, while secondary outcomes were supportive relationships and life skills. Where possible, results were pooled in a meta-analysis. Certainty of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation. Fourteen studies published in 27 reports were identified that examined independent living programs (ILPs) (n = 5), intensive support services (n = 2), coaching and peer support (C&PSP) (n = 2), transitional housing (n = 1), health information or coaching (n = 2), and extended care (n = 2). All but one study was conducted in the United States. Twenty small meta-analyses were undertaken encompassing ILPs and C&PSP, with two showing results that favored the intervention with certainty. The level of confidence in each meta-analysis was considered very low. A significant risk of bias was identified in each of the included studies. While some interventions showed promise, particularly extended care, the scope and strength of included evidence is insufficient to recommend any included approach.

Comparative effectiveness of psychological interventions for treating the psychological consequences of sexual abuse in children and adolescents: a network meta-analysis.

BACKGROUND: Following sexual abuse, children and young people may develop a range of psychological problems, including anxiety, depression, post-traumatic stress disorder (PTSD), and a range of behaviour problems. Those working with children and young people experiencing these problems may use one or more of a range of psychological approaches. OBJECTIVES: To assess the relative effectiveness of psychological interventions compared to other treatments or no treatment controls, to overcome psychological consequences of sexual abuse in children and young people up to 18 years of age. Secondary objectives To rank psychotherapies according to their effectiveness. To compare different 'doses' of the same intervention. SEARCH METHODS: In November 2022 we searched CENTRAL, MEDLINE, Embase, PsycINFO, 12 other databases and two trials registers. We reviewed the reference lists of included studies, alongside other work in the field, and communicated with the authors of included studies. SELECTION CRITERIA: We included randomised controlled trials comparing psychological interventions for sexually abused children and young people up to 18 years old with other treatments or no treatments. Interventions included: cognitive behavioural therapy (CBT), psychodynamic therapy, family therapy, child centred therapy (CCT), and eye movement desensitisation and reprocessing (EMDR). We included both individual and group formats. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data and assessed the risk of bias for our primary outcomes (psychological distress/mental health, behaviour, social functioning, relationships with family and others) and secondary outcomes (substance misuse, delinquency, resilience, carer distress and efficacy). We considered the effects of the interventions on all outcomes at post-treatment, six months follow-up and 12 months follow-up. For each outcome and time point with sufficient data, we performed random-effects network and pairwise meta-analyses to determine an overall effect estimate for each possible pair of therapies. Where meta-analysis was not possible, we report the summaries from single studies. Due to the low number of studies in each network, we did not attempt to determine the probabilities of each treatment being the most effective relative to the others for each outcome at each time point. We rated the certainty of evidence with GRADE for each outcome. MAIN RESULTS: We included 22 studies (1478 participants) in this review. Most of the participants were female (range: 52% to 100%), and were mainly white. Limited information was provided on socioeconomic status of participants. Seventeen studies were conducted in North America, with the remaining studies conducted in the UK (N = 2), Iran (N = 1), Australia (N = 1) and Democratic Republic of Congo (N = 1). CBT was explored in 14 studies and CCT in eight studies; psychodynamic therapy, family therapy and EMDR were each explored in two studies. Management as usual (MAU) was the comparator in three studies and a waiting list was the comparator in five studies. For all outcomes, comparisons were informed by low numbers of studies (one to three per comparison), sample sizes were small (median = 52, range 11 to 229) and networks were poorly connected. Our estimates were all imprecise and uncertain. Primary outcomes At post-treatment, network meta-analysis (NMA) was possible for measures of psychological distress and behaviour, but not for social functioning. Relative to MAU, there was very low certainty evidence that CCT involving parent and child reduced PTSD (standardised mean difference (SMD) -0.87, 95% confidence intervals (CI) -1.64 to -0.10), and CBT with only the child reduced PTSD symptoms (SMD -0.96, 95% CI -1.72 to -0.20). There was no clear evidence of an effect of any therapy relative to MAU for other primary outcomes or at any other time point. Secondary outcomes Compared to MAU, there was very low certainty evidence that, at post-treatment, CBT delivered to the child and the carer might reduce parents' emotional reactions (SMD -6.95, 95% CI -10.11 to -3.80), and that CCT might reduce parents' stress. However, there is high uncertainty in these effect estimates and both comparisons were informed only by one study. There was no evidence that the other therapies improved any other secondary outcome. We attributed very low levels of confidence for all NMA and pairwise estimates for the following reasons. Reporting limitations resulted in judgements of 'unclear' to 'high' risk of bias in relation to selection, detection, performance, attrition and reporting bias; the effect estimates we derived were imprecise, and small or close to no change; our networks were underpowered due to the low number of studies informing them; and whilst studies were broadly comparable with regard to settings, the use of a manual, the training of the therapists, the duration of treatment and number of sessions offered, there was considerable variability in the age of participants and the format in which the interventions were delivered (individual or group). AUTHORS' CONCLUSIONS: There was weak evidence that both CCT (delivered to child and carer) and CBT (delivered to the child) might reduce PTSD symptoms at post-treatment. However, the effect estimates are uncertain and imprecise. For the remaining outcomes examined, none of the estimates suggested that any of the interventions reduced symptoms compared to management as usual. Weaknesses in the evidence base include the dearth of evidence from low- and middle-income countries. Further, not all interventions have been evaluated to the same extent, and there is little evidence regarding the effectiveness of interventions for male participants or those from different ethnicities. In 18 studies, the age ranges of participants ranged from 4 to 16 years old or 5 to 17 years old. This may have influenced the way in which the interventions were delivered, received, and consequently influenced outcomes. Many of the included studies evaluated interventions that were developed by members of the research team. In others, developers were involved in monitoring the delivery of the treatment. It remains the case that evaluations conducted by independent research teams are needed to reduce the potential for investigator bias. Studies addressing these gaps would help to establish the relative effectiveness of interventions currently used with this vulnerable population.

Protocol for a systematic review of policies, programs or interventions designed to improve health and wellbeing of young people leaving the out-of-home care system.

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.

Cost-effectiveness of specialist eating disorders services for children and adolescents with anorexia nervosa: a national surveillance study.

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.

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.

Rights Based, Participatory Interviews with Disabled Children and Young People: Practical and Methodological Considerations.

There has been an increased emphasis on the voice of the child since the ratification of the United Nations Convention on the Rights of the Child in 1991. Since that time, health and social care researchers have increasingly involved disabled children and young people in research, rather than relying on the views of adults as proxies, for example, parents and professionals. Drawing on doctoral research and the extensive experience of the authors, the aim of this article is to critically reflect on "what worked" along with the challenges of interviewing the children and young people who took part. Practical and methodological issues, such as the need for thorough preparation, the interview process, understanding the children and young people and managing the presence of others are discussed. Finally, recommendations are made for future researchers, including making participation fun, using a sensitive and individualized approach and conducting multiple visits. It is only by considering these factors that we can meaningfully involve disabled children and young people and facilitate their participation in research interviews. Emphasis here is on the practical issues rather than ethical issues that have been published elsewhere.

Cognitive-behavioural therapy (CBT) interventions for young people aged 10 to 18 with harmful sexual behaviour.

BACKGROUND: Around 1 in 1000 adolescents aged 12 to 17 years old display problematic or harmful sexual behaviour (HSB). Examples include behaviours occurring more frequently than would be considered developmentally appropriate; accompanied by coercion; involving children of different ages or stages of development; or associated with emotional distress. Some, but not all, young people engaging in HSB come to the attention of authorities for investigation, prosecution or treatment. Depending on policy context, young people with HSB are those whose behaviour has resulted in a formal reprimand or warning, conviction for a sexual offence, or civil measures. Cognitive-behavioural therapy (CBT) interventions are based on the idea that by changing the way a person thinks, and helping them to develop new coping skills, it is possible to change behaviour. OBJECTIVES: To evaluate the effects of CBT for young people aged 10 to 18 years who have exhibited HSB. SEARCH METHODS: In June 2019, we searched CENTRAL, MEDLINE, Embase, 12 other databases and three trials registers. We also examined relevant websites, checked reference lists and contacted authors of relevant articles. SELECTION CRITERIA: We included all relevant randomised controlled trials (RCTs) using parallel groups. We evaluated CBT treatments compared with no treatment, waiting list or standard care, irrespective of mode of delivery or setting, given to young people aged 10 to 18 years, who had been convicted of a sexual offence or who exhibited HSB. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We found four eligible RCTs (115 participants). Participants in two studies were adolescent males aged 12 to 18 years old. In two studies participants were males simply described as "adolescents." Three studies took place in the USA and one in South Africa. The four studies were of short duration: one lasted two months; two lasted three months; and one lasted six months. No information was available on funding sources. Two studies compared group-based CBT respectively to no treatment (18 participants) or treatment as usual (21 participants). The third compared CBT with sexual education (16 participants). The fourth compared CBT (19 participants) with mode-deactivation therapy (21 participants) and social skills training (20 participants). Three interventions delivered treatment in a residential setting by someone working there, and one in a community setting by licensed therapist undertaking a PhD. CBT compared with no treatment or treatment as usual Primary outcomes No study in this comparison reported the impact of CBT on any measure of primary outcomes (recidivism, and adverse events such as self-harm or suicidal behaviour). Secondary outcomes There was little to no difference between CBT and treatment as usual on cognitive distortions in general (mean difference (MD) 1.56, 95% confidence interval (CI) -11.54 to 14.66, 1 study, 18 participants; very low-certainty evidence), assessed with Abel and Becker Cognition Scale (higher scores indicate more problematic distortions); and specific cognitive distortions about rape (MD 8.75, 95% CI 2.83 to 14.67, 1 study, 21 participants; very low-certainty evidence), measured with the Bumby Cardsort Rape Scale (higher scores indicate more justifications, minimisations, rationalisations and excuses for HSB). One study (18 participants) reported very low-certainty evidence that CBT may result in greater improvements in victim empathy (MD 5.56, 95% CI 0.94 to 10.18), measured with the Attitudes Towards Women Scale, compared with no treatment. One additional study also measured this, but provided no usable data. CBT compared with alternative interventions Primary outcomes One study (59 participants) found little to no difference between CBT and alternative treatments on post-treatment sexual aggression scores (MD 0.09, 95% CI -0.18 to 0.37, very low-certainty evidence), assessed using Daily Behaviour Reports and Behaviour Incidence Report Forms. No study in this comparison reported the impact of CBT on any measure of our remaining primary outcomes. Secondary outcomes One study (16 participants) provided very low-certainty evidence that, compared to sexual education, mean cognitive distortions pertaining to justification or taking responsibility for actions (MD 3.27, 95% CI -4.77 to -1.77) and apprehension confidence (MD 2.47 95% CI -3.85 to -1.09) may be lower in the CBT group. The same study indicated that mean cognitive distortions pertaining to social-sexual desirability may be lower in the CBT group, and there may be little to no difference between the groups for cognitive distortions pertaining to inappropriate sexual fantasies measured with the Multiphasic Sex Inventory. AUTHORS' CONCLUSIONS: It is uncertain whether CBT reduces HSB in male adolescents compared to other treatments. All studies had insufficient detail in what they reported to allow for full assessment of risk of bias. 'Risk of bias' judgements were predominantly rated as unclear or high. Sample sizes were very small, and the imprecision of results was significant. There is very low-certainty evidence that group-based CBT may improve victim empathy when compared to no treatment, and may improve cognitive distortions when compared to sexual education, but not treatment as usual. Further research is likely to change the estimate. More robust evaluations of both individual and group-based CBT are required, particularly outside North America, and which look at the effects of CBT on diverse participants.

Ethical considerations when conducting research with children and young people with disabilities in health and social care.

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.

Video feedback for parental sensitivity and attachment security in children under five years.

BACKGROUND: Children who are securely attached to at least one parent are able to be comforted by that parent when they are distressed and explore the world confidently by using that parent as a 'secure base'. Research suggests that a secure attachment enables children to function better across all aspects of their development. Promoting secure attachment, therefore, is a goal of many early interventions. Attachment is mediated through parental sensitivity to signals of distress from the child. One means of improving parental sensitivity is through video feedback, which involves showing a parent brief moments of their interaction with their child, to strengthen their sensitivity and responsiveness to their child's signals. OBJECTIVES: To assess the effects of video feedback on parental sensitivity and attachment security in children aged under five years who are at risk for poor attachment outcomes. SEARCH METHODS: In November 2018 we searched CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, nine other databases and two trials registers. We also handsearched the reference lists of included studies, relevant systematic reviews, and several relevant websites SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs that assessed the effects of video feedback versus no treatment, inactive alternative intervention, or treatment as usual for parental sensitivity, parental reflective functioning, attachment security and adverse effects in children aged from birth to four years 11 months. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures expected by Cochrane. MAIN RESULTS: This review includes 22 studies from seven countries in Europe and two countries in North America, with a total of 1889 randomised parent-child dyads or family units. Interventions targeted parents of children aged under five years, experiencing a wide range of difficulties (such as deafness or prematurity), or facing challenges that put them at risk of attachment issues (for example, parental depression). Nearly all studies reported some form of external funding, from a charitable organisation (n = 7) or public body, or both (n = 18). We considered most studies as being at low or unclear risk of bias across the majority of domains, with the exception of blinding of participants and personnel, where we assessed all studies as being at high risk of performance bias. For outcomes where self-report measures were used, such as parental stress and anxiety, we rated all studies at high risk of bias for blinding of outcome assessors. Parental sensitivity. A meta-analysis of 20 studies (1757 parent-child dyads) reported evidence of that video feedback improved parental sensitivity compared with a control or no intervention from postintervention to six months' follow-up (standardised mean difference (SMD) 0.34, 95% confidence interval (CI) 0.20 to 0.49, moderate-certainty evidence). The size of the observed impact compares favourably to other, similar interventions. Parental reflective functioning. No studies reported this outcome. Attachment security. A meta-analysis of two studies (166 parent-child dyads) indicated that video feedback increased the odds of being securely attached, measured using the Strange Situation Procedure, at postintervention (odds ratio 3.04, 95% CI 1.39 to 6.67, very low-certainty evidence). A second meta-analysis of two studies (131 parent-child dyads) that assessed attachment security using a different measure (Attachment Q-sort) found no effect of video feedback compared with the comparator groups (SMD 0.02, 95% CI -0.33 to 0.38, very low-certainty evidence). Adverse events. Eight studies (537 parent-child dyads) contributed data at postintervention or short-term follow-up to a meta-analysis of parental stress, and two studies (311 parent-child dyads) contributed short-term follow-up data to a meta-analysis of parental anxiety. There was no difference between intervention and comparator groups for either outcome. For parental stress the SMD between video feedback and control was -0.09 (95% CI -0.26 to 0.09, low-certainty evidence), while for parental anxiety the SMD was -0.28 (95% CI -0.87 to 0.31, very low-certainty evidence). Child behaviour. A meta-analysis of two studies (119 parent-child dyads) at long-term follow-up found no evidence of the effectiveness of video feedback on child behaviour (SMD 0.04, 95% CI -0.33 to 0.42, very low-certainty evidence). A moderator analysis found no evidence of an effect for the three prespecified variables (intervention type, number of feedback sessions and participating carer) when jointly tested. However, parent gender (both parents versus only mothers or only fathers) potentially has a statistically significant negative moderation effect, though only at α (alpha) = 0.1 AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that video feedback may improve sensitivity in parents of children who are at risk for poor attachment outcomes due to a range of difficulties. There is currently only little, very low-certainty evidence regarding the impact of video feedback on attachment security, compared with control: results differed based on the type of measure used, and follow-up was limited in duration. There is no evidence that video feedback has an impact on parental stress or anxiety (low- and very low-certainty evidence, respectively). Further evidence is needed regarding the longer-term impact of video feedback on attachment and more distal outcomes such as children's behaviour (very low-certainty evidence). Further research is needed on the impact of video-feedback on paternal sensitivity and parental reflective functioning, as no study measured these outcomes. This review is limited by the fact that the majority of included parents were mothers.

Incidence of anorexia nervosa in young people in the UK and Ireland: a national surveillance study.

OBJECTIVES: This 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. DESIGN: Observational, 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. SETTING: The study was based in the UK and Ireland. PARTICIPANTS: Clinician-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 MEASURES: Annual incidence rates (IRs) estimated as confirmed new cases per 100 000 population at risk. RESULTS: 305 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. CONCLUSION: These 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.

Families and Schools Together (FAST) for improving outcomes for children and their families.

BACKGROUND: Parents and carers have a major influence on children's learning and development from birth, through the school years, and into adulthood. Parental contributions to education include providing a secure environment in which to learn, providing intellectual stimulation, transmitting social norms and values, shaping the child's resilience through fostering literacy and problem-solving, and encouraging personal and social aspiration. Increasingly, providers of formalised education are recognising the primary role of parents, carers, and the wider family, as well as peers and the environment, in shaping children's education, health, and life experiences. OBJECTIVES: To assess the effectiveness of the Families and Schools Together (FAST) programme in improving outcomes among children and their families. SEARCH METHODS: Between October 2018 and December 2018, we searched CENTRAL, MEDLINE, Embase, PsycINFO, 11 additional databases, and three trial registers. We handsearched the reference lists of included studies and relevant reports and reviews, contacted the programme developer and independent researchers, and searched relevant websites to identify other eligible studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and quasi-RCTs examining the effects of FAST, relative to waiting list, usual or alternative services, or no intervention, on outcomes for children (aged from birth to completion of compulsory education) and their families. DATA COLLECTION AND ANALYSIS: At least two review authors independently evaluated the records retrieved from the search for relevance. One review author (JV) extracted data from eligible studies with a second independent review author (AF, DK, or SL). Review authors consulted with one another to resolve disagreements. We used a fixed-effect model for meta-analysis. We presented results as standardised mean differences (SMDs) because all outcomes were continuously scaled, and we accompanied these with 95% confidence intervals (CIs). We used the GRADE approach to assess the certainty of evidence for each outcome. MAIN RESULTS: We identified 10 completed RCTs, most of which were relatively recent (2007 or later) and were conducted with at least some involvement from the intervention developer or the FAST organisation. Nine of the 10 trials were from the USA; the other was from the UK. Children were young (five to nine years old; mean age approximately six years), and therefore, whilst not so named in the reports, evaluations consisted of what is sometimes referred to as 'Kids FAST' and sometimes 'Elementary Level FAST'). Among the USA-based studies, at least 62% of participants were members of a racial/ethnic minority group (most commonly, African American or Latino). FAST was usually delivered in schools after the school day. Trials lasted about eight weeks and usually examined the effects of FAST relative to no additional intervention. Most studies were funded by agencies in the US federal government. We judged the certainty of evidence in the included studies to be moderate or low for the main review outcomes. Failure to include all families in outcome analyses (attrition) and possible bias in recruitment of families into the trials were the main limitations in the evidence.We included over 9000 children and their families in at least one meta-analysis. The follow results relate to meta-analyses of data at long-term follow-up.Primary outcomesFour studies (approximately 6276 children) assessed child school performance at long-term follow-up. The effect size was very small, and the CI did not include effects that, if real, suggest possibly important positive or negative effects if viewed from an individual perspective (SMD -0.02, 95% CI -0.11 to 0.08). We assessed the certainty of evidence for this outcome as moderate. No studies assessed child adverse events, parental substance use, or parental stress.Secondary outcomesParent reports of child internalising behaviour (SMD -0.03, 95% CI -0.11 to 0.17; 4 RCTs, approximately 908 children; low-certainty evidence) and family relationships (SMD 0.08, 95% CI -0.03 to 0.19; 4 RCTs, approximately 2569 children; moderate-certainty evidence) also yielded CIs that did not include effects that, if real, suggest possibly important positive or negative effects.The CI for parent reports of child externalising behaviour, however, did include effects that, if real, were possibly large enough to be important (SMD -0.19, 95% CI -0.32 to -0.05; 4 RCTs, approximately 754 children; low-certainty evidence). AUTHORS' CONCLUSIONS: Given these results, it is hard to support the assertion that assignment to FAST is associated with important positive outcomes for children and their parents.

Considerations of complexity in rating certainty of evidence in systematic reviews: a primer on using the GRADE approach in global health.

Public health interventions and health technologies are commonly described as 'complex', as they involve multiple interacting components and outcomes, and their effects are largely influenced by contextual interactions and system-level processes. Systematic reviewers and guideline developers evaluating the effects of these complex interventions and technologies report difficulties in using existing methods and frameworks, such as the Grading of Recommendations Assessment, Development and Evaluation (GRADE). As part of a special series of papers on implications of complexity in the WHO guideline development, this paper serves as a primer on how to consider sources of complexity when using the GRADE approach to rate certainty of evidence. Relevant sources of complexity in systematic reviews, health technology assessments and guidelines of public health are outlined and mapped onto the reported difficulties in rating the estimates of the effect of these interventions. Recommendations on how to address these difficulties are further outlined, and the need for an integrated use of GRADE from the beginning of the review or guideline development is emphasised. The content of this paper is informed by the existing GRADE guidance, an ongoing research project on considering sources of complexity when applying the GRADE approach to rate certainty of evidence in systematic reviews and the review authors' own experiences with using GRADE.

Barriers to the registration and conduct of Cochrane systematic reviews of traditional East Asian medicine therapies.

INTRODUCTION: Traditional East Asian medicine (TEAM) is widely used in Asia and increasingly in the West. Systematic reviews (SRs) are the best summaries of the potential benefits or harms of interventions, and Cochrane is a leading international SR organization. Cochrane perspectives on the barriers to the initiation and completion of Cochrane SRs of TEAM therapies were solicited. METHODS: Cochrane Review Groups (CRGs) were identified from the online listing of CRGs at cochrane.org and a link to an online survey was e-mailed to the primary contact for each CRG. RESULTS: Forty-eight responses were received on behalf of 49/53 (92%) CRGs. Most CRGs had experience producing TEAM reviews, primarily in acupuncture or herbal medicine. The main barriers to taking on a new TEAM review were difficulty in understanding and assessing the intervention, and the low priority of TEAM topics. Problems with the quality and accessibility of randomized trials in TEAM were cited as a major concern. CRGs suggested that the quality and accessibility of randomized trials should be improved, that the methodological and language expertise of authors should be enhanced, and that further peer review expertise should be made available to CRGs. CONCLUSIONS: TEAM topics are covered in Cochrane reviews but are often considered low-priority. This survey highlights Cochrane concerns about the quality of the underlying evidence base and the training of the author teams as barriers to successful SR completion. Specific approaches are proposed to increase the number of TEAM reviews and address the limitations of TEAM research processes within Cochrane.

Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension.

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.

CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials.

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.

Are one-stop centres an appropriate model to deliver services to sexually abused children in urban Malawi?

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.

Right from the start: protocol for a pilot study for a randomised trial of the New Baby Programme for improving outcomes for children born to socially vulnerable mothers.

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.

Parents Suggest Which Indicators of Progress and Outcomes Should be Measured in Young Children with Autism Spectrum Disorder.

Evaluation of interventions for children with autism spectrum disorder (ASD) is hampered by the multitude of outcomes measured and tools used. Measurement in research with young children tends to focus on core impairments in ASD. We conducted a systematic review of qualitative studies of what matters to parents. Parent advisory groups completed structured activities to explore their perceptions of the relative importance of a wide range of outcome constructs. Their highest ranked outcomes impacted directly on everyday life and functioning (anxiety, distress, hypersensitivity, sleep problems, happiness, relationships with brothers and sisters, and parent stress). Collaboration between professionals, researchers and parents/carers is required to determine an agreed core set of outcomes to use across evaluation research.

Randomized controlled trial and economic evaluation of nurse-led group support for young mothers during pregnancy and the first year postpartum versus usual care.

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.

The Senior Toronto Oncology Panel (STOP) Study: Research Participation for Older Adults With Cancer and Caregivers.

Background: Patient engagement in research may lead to better-designed studies and improved health outcomes. The objectives of this study were to identify the research priorities of older adults with cancer (OAWCs) and their caregivers and examine how to engage these individuals in research teams and what supports are needed. Methods: We conducted 3 public meetings and 7 focus groups to delineate research priorities and the supports needed to facilitate integration of OAWCs and their caregivers on research teams. Results: A total of 33 older adults and 19 caregivers attended a public meeting and 27 older adults and 17 caregivers participated in a focus group. Most of the OAWCs and their caregivers had never participated in research before. Three themes were identified from the focus groups: (1) motivation to be on a team; (2) ability to make meaningful contributions; and (3) logistical considerations to facilitate engagement. Most participants were motivated to be a research team member and be involved in all steps of research if it could benefit them or future patients and caregivers. OAWCs and their caregivers were highly motivated to improve outcomes. Required logistics included flexibility regarding time and location, accessibility to computer technology, transportation support, materials worded in lay language, and attending/having short training sessions, as well as the presence of peer support. Conclusions: OAWCs and their caregivers are very motivated and willing to participate in research and to be research team members. Logistics and the social aspects of being on a team are important.