Registry versus publication: discrepancy of primary outcomes and possible outcome reporting bias in child and adolescent mental health.

Outcome reporting bias is one of the fundamental forms of publication bias. It implies publishing only outcomes that have positive results. The aim of this observational study was to explore primary outcome discrepancies between registry of clinical trials and their corresponding publications, since these can indicate outcome reporting bias in child mental health. Data were extracted from completed interventional clinical trials from ClinicalTrial.gov registry and its Archive site. Trials were registered under "Behaviours and Mental Disorders" category, and conducted on underage participants (0-17 years). Their primary outcomes were compared to those published in publication which had a corresponding NCT number stated in the text. Sixteen percent of trials did not have the minimum information on primary outcome stated in the registry-neither the measure used nor the measurement time points; 38.9% of trials had the minimum information stated to describe primary outcome, while only 3.3% of trials had all the necessary elements stated in the registry. Most of the publication in our sample had positive results (66.4%). Half of the trials registered before completion had non-matching primary outcomes in the registry and publication; 85.4% of trials with non-matching outcomes indicated possible outcome reporting bias for some of the primary outcome. Middle-sized trials and industry-funded trials were related with higher quality of primary outcome registration. Industry funding was related with positive findings in publication. Non-industry funding proved to be the only significant predictor of discrepancy between registered and published primary outcomes, and possible outcome reporting bias. Journal impact factor was not related with any of the outcome measures. The main limitation of the study is that it primarily offers an insight into discrepancy of registered and published outcomes. The methodology does not imply an access to results of unpublished outcomes - therefore, it was not possible to determine the presence of the bias with sufficient certainty in large number of trials. Further research should be done with improved methodology and additional data.

Low dissemination rates, non-transparency of trial premature cessation and late registration in child mental health: observational study of registered interventional trials.

The aim of this observational study was to explore trial premature cessation, non-publication and trial registration time in child mental health. Data were extracted for "closed" trials in Clinicaltrials.gov registry and European Union Clinical Trial Register (EUCTR) and corresponding publications of completed trials indexed in three data bases (PubMed, Scopus and Google Scholar). We restricted the extraction to the 'Behaviours and Mental Disorders' category and participants' age of 0-17 years. Outcome measures were trial completion, results reporting within a year after the trial completion, publishing an article in a peer-reviewed journal within an average time to publish (729 days), and registration time. The number of EUCTR trials was relatively small (n = 35) and with many inconsistencies. Out of 827 "closed" trials extracted from ClinicalTrials.gov, 69% were completed, 24.2% of prematurely ceased trials did not report reasons for early termination, 12.2% of the completed trials had results reported within a year, and 29.3% had an article published within 24 months after completion. Middle-sized (100-499 participants) and behavioural trials had higher chances of being successfully completed. Middle-sized and industry-funded trials were associated with results reporting. Chances for publishing an article were lower for industry-funded trials. Industry funding and drug interventions were related to timely registration. Large sample and non-industry funding were related to retrospective registration, which was recorded more often in recent years than before (we observed trials registered from 2002 until 2017). This study found low dissemination rates in the field of child mental health, with worrying under-reporting of premature termination causes. These findings indicate that more children are being subjected to unnecessary risk that comes with trial participation.

Transition as a topic in psychiatry training throughout Europe: trainees' perspectives.

The majority of adolescents with mental health problems do not experience continuity of care when they reach the transition boundary of their child and adolescent mental health service. One of the obstacles for a smooth transition to adult mental health services concerns the lack of training for health-care professionals involved in the transition process. This study aims to seek psychiatric trainees' opinions regarding training on transition and the knowledge and skills required for managing transition. A survey was distributed to trainees residing in European countries. Trainees from 36 countries completed the questionnaire, of which 63% reported that they came into contact with youth and young adults (16-26 years) during their clinical practice. Twenty-seven percent of trainees stated they have good to very good knowledge about the transition process. Theoretical training about transition was reported in only 17% of the countries, and practical training in 28% of the countries. Ninety-four percent of trainees indicated that further training about transition is necessary. The content of subsequent transition-related training can be guided by the findings of the MILESTONE project.

A cross-cultural qualitative study of the ethical aspects in the transition from child mental health services to adult mental health services.

BACKGROUND: Transitioning from Child and Adolescent Mental Health Services (CAMHS) to Adult Mental Health Services (AMHS) raises novel ethical aspects for healthcare professionals, as well as for young people, their parents and carers. METHOD: Focus groups were conducted in Croatia, Ireland and the United Kingdom with youth mental health groups and youth representatives with no mental health (MH) remit. One hundred and eleven participants, aged from 16 to 60 years, contributed to discussions. RESULTS: Perpetuation of stigma, autonomy and decision-making were central themes as both enablers and deterrents of successful transition. The tension between professional (and at times parental) paternalism and young persons' growing autonomy was well captured in the themes; (a) desired practice, (b) who should decide, (c) the process of decision-making and (d) potential harm(s). CONCLUSIONS: This study provides insight into the ethical values, particularly autonomy and collaboratively working, which people expect to underpin the transition between CAMHS and AMHS. KEY PRACTITIONER MESSAGE: Engaging young people early in making decisions about their future care can enhance trust between practitioner and the young person. In addition to diagnosis, a number of factors (such as moving home; waiting lists and stigma) may need to be taken into account when considering the direction of future health care. When possible, alternatives to AMHS should be considered if considered by the young person to be a less-stigmatising treatment option.

Correction to: The interface between child/adolescent and adult mental health services: results from a European 28­country survey.

The original version of this article contained an error in Table 1. The correct table is presented below.

The interface between child/adolescent and adult mental health services: results from a European 28-country survey.

Transition-related discontinuity of care is a major socioeconomic and societal challenge for the EU. The current service configuration, with distinct Child and Adolescent Mental Health (CAMHS) and Adult Mental Health Services (AMHS), is considered a weak link where the care pathway needs to be most robust. Our aim was to delineate transitional policies and care across Europe and to highlight current gaps in care provision at the service interface. An online mapping survey was conducted across all 28 European Countries using a bespoke instrument: The Standardized Assessment Tool for Mental Health Transition (SATMEHT). The survey was directed at expert(s) in each of the 28 EU countries. The response rate was 100%. Country experts commonly (12/28) reported that between 25 and 49% of CAMHS service users will need transitioning to AMHS. Estimates of the percentage of AMHS users aged under 30 years who had has previous contact with CAMHS were most commonly in the region 20-30% (33% on average).Written policies for managing the interface were available in only four countries and half (14/28) indicated that no transition support services were available. This is the first survey of CAMHS transitional policies and care carried out at a European level. Policymaking on transitional care clearly needs special attention and further elaboration. The Milestone Study on transition should provide much needed data on transition processes and outcomes that could form the basis for improving policy and practice in transitional care.

Cross-Cultural Measurement Invariance of Adolescent Self-Report on the Pediatric Quality of Life Inventory™ 4.0.

This study evaluated the cross-cultural measurement invariance of the Pediatric Quality of Life Inventory version 4.0 (PedsQL™) among adolescents sampled from Bulgaria, Croatia, India, Indonesia, Nigeria, Serbia, and Turkey. The multiple-indicator multiple-cause (MIMIC) model was used, which allowed controlling of demographic variables (i.e., age, gender, and socioeconomic status). Significant effects of country on scores within the PedsQL™ domains were observed, with up to 17 items showing differential item functioning (DIF) across the countries. We did not find support for cross-cultural measurement invariance hypotheses for scores on the PedsQL™ adolescent self-report in this study. Researchers should use caution in making cross-cultural quality of life comparisons while using the PedsQL.

Pathological narcissism and depressive symptoms in psychiatric outpatients: mediating role of dysfunctional attitudes.

OBJECTIVE: The aim of this study was to examine the relationships between pathological narcissism (narcissistic grandiosity and narcissistic vulnerability), dysfunctional attitudes (perfectionism and dependency on other people), and depressive symptoms in psychiatric outpatients. METHOD: A sample of 234 adult psychiatric outpatients (57.3% male; mean age 44.39 years) completed the Pathological Narcissism Inventory, the Dysfunctional Attitudes Scale-Form A, and the Depression, Anxiety, Stress Scales-21. RESULTS: Narcissistic vulnerability exhibited unique positive correlations with depressive symptoms, whereas narcissistic grandiosity showed substantially weaker correlations with depressive symptoms. Perfectionism partially mediated the relationship between narcissistic vulnerability and depressive symptoms. The mediating role of dependency was not confirmed. CONCLUSIONS: Among adult psychiatric outpatients, narcissistic vulnerability is more strongly related to depressive symptoms than narcissistic grandiosity, and dysfunctional perfectionism represents one of the underlying mechanisms of this relationship. The implications of these findings are discussed in relation to the Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria and the treatment of pathological narcissism.

Metabolic syndrome and inflammation markers in patients with schizophrenia and recurrent depressive disorder.

BACKGROUND: The high prevalence of metabolic syndrome in patients with psychiatric disorders, almost double the prevalence reported for the general population, is worrying. The aim of this study is to investigate the presence of metabolic syndrome and inflammatory marker levels in patients with schizophrenia and recurrent depressive disorder in a Croatian psychiatric sample. SUBJECTS AND METHODS: This study included 62 inpatients with schizophrenia and 62 with recurrent depressive disorder treated at the Department of Psychiatry, University Hospital Centre Split, enrolled from November 2011 until May 2012. The cases were compared to 124 healthy subjects from the general population. RESULTS: The presence of metabolic syndrome was found in 56.5% of the patients with schizophrenia and 53.2% of the patients with depression, which was significantly more prevalent than in the control group (32.3%). The levels of inflammation markers (i.e., C-reactive protein and PAI-1) were significantly higher among patients with metabolic syndrome. CONCLUSIONS: Patients with schizophrenia and recurrent depressive disorder demonstrate a high prevalence of metabolic syndrome that is also related to inflammation processes. In the context of integrative medicine, clinicians and researchers should consider psychiatric patients within a holistic approach.

Turning 18 in mental health services: a multicountry qualitative study of service user experiences and views.

BACKGROUND: Worldwide, the division between Child and Adolescent Mental Health Services (CAMHS) and Adult Mental Health Services (AMHS) has frequently resulted in fragmented care with an unprepared, non-gradual transition. To improve continuity of care and other service transition experiences, service user input is essential. However, such previous qualitative studies are from a decade ago or focused on one mental disorder or country. The aim of the present study was to learn from service users' transition experiences and suggested improvements. METHODS: Semi-structured interviews were held with young people aged 18-24 and/or parents/caregivers in the United Kingdom, Ireland, the Netherlands and Croatia. Inclusion was based on the experience of specialist mental health care before and after turning 18. Thematic analysis of transcribed and translated interview transcripts was performed using ATLAS.ti 9. RESULTS: Main themes of service user experiences included abrupt changes in responsibilities, various barriers and a lack of preparation, communication and ongoing care. Young people expressed a great need for continuity of care. Their suggestions to improve transitional care included early and adequate preparation, joint working, improved communication from and between services, overlapping services, staying at CAMHS for longer and designated youth mental health teams. CONCLUSIONS: Young people who experienced care before and after turning 18 suggested either altering the age limits of services or ensuring early preparation and communication regarding the transition and finding AHMS. This communication should include general changes when turning 18. Further considerations include increasing collaboration and overlap between CAMHS and AMHS.

Adaptation and validation of the On Your Own Feet - Transition Experiences Scale evaluating transitions to adult services among adolescent mental health service users in Europe.

PURPOSE: Experiences of young people transitioning from Child and Adolescent Mental Health Services (CAMHS) to Adult Mental Health Services (AMHS) have mostly been investigated qualitatively. This study adapts and validates the On Your Own Feet - Transition Experiences Scale (OYOF-TES) in a sample of CAMHS users in Europe and describes young people's and parents' experiences with transition and end of care at CAMHS. METHODS: The OYOF-TES was adapted to a mental health setting and translated. An End Of Care (OYOF-EOC) version (self- and parent-report) was developed. A total of 457 young people and 383 parents completed an OYOF-TES or OYOF-EOC. Psychometric properties and descriptives are presented. RESULTS: The Cronbach's alphas of the OYOF-TES and OYOF-EOC parent/self-report ranged from 0.92 to 0.94. The two-factor structure was confirmed. The mean overall satisfaction reported by young people was 6.15 (0-10; SD=2.92) for transition and 7.14 (0-10; SD=2.37) for care ending. However, 26.7%-36.4% of young people were unsatisfied. DISCUSSION: The OYOF-TES and OYOF-EOC can be used reliably in mental healthcare settings to capture young people's and parents' transition experiences. The majority of young people and parents was satisfied with the process of transition and care ending, yet a third of young people had negative experiences.

The Association Between Trajectories of Self-reported Psychotic Experiences and Continuity of Mental Health Care in a Longitudinal Cohort of Adolescents and Young Adults.

BACKGROUND AND HYPOTHESIS: Young people (YP) with psychotic experiences (PE) have an increased risk of developing a psychiatric disorder. Therefore, knowledge on continuity of care from child and adolescent (CAMHS) to adult mental health services (AMHS) in relation to PE is important. Here, we investigated whether the self-reported trajectories of persistent PE were associated with likelihood of transition to AMHS and mental health outcomes. STUDY DESIGN: In this prospective cohort study, interviews and questionnaires were used to assess PE, mental health, and service use in 763 child and adolescent mental health service users reaching their service's upper age limit in 8 European countries. Trajectories of self-reported PE (3 items) from baseline to 24-month follow-up were determined using growth mixture modeling (GMM). Associations were assessed with auxiliary variables and using mixed models. Study results. At baseline, 56.7% of YP reported PE. GMM identified 5 trajectories over 24 months: medium increasing (5.2%), medium stable (11.7%), medium decreasing (6.5%), high decreasing (4.2%), and low stable (72.4%). PE trajectories were not associated with continuity of specialist care or transition to AMHS. Overall, YP with PE reported more mental health problems at baseline. Persistence of PE or an increase was associated with poorer outcomes at follow-up. CONCLUSIONS: PE are common among CAMHS users when reaching the upper age limit of CAMHS. Persistence or an increase of PE was associated with poorer mental health outcomes, poorer prognosis, and impaired functioning, but were less discriminative for continuity of care.

Mentalization and psychopharmacotherapy in patients with personality and eating disorders.

Contemporary psychiatry pays more and more attention to the patient's capacity regarding acceptance of psychiatric drugs. Understanding the basis of our treatment's effectiveness becomes more challenging. To understand psychiatric treatment psychiatrists must pay full attention to mentalizing and the conditions under which this basic human capacity becomes impaired especially in those suffering from personality and eating disorders. This paper discusses the meaning and clinical applications of the mentalizing related to psychopharmacotherapy for personality and eating disorders patients, including suicidality.

Healthcare costs for young people transitioning the boundary between child/adolescent and adult mental health services in seven European countries: results from the MILESTONE study.

BACKGROUND: The boundary between services for children and adolescents and adults has been identified as problematic for young people with mental health problems. AIMS: To examine the use and cost of healthcare for young people engaged in mental healthcare before and after the child/adolescent and adult service boundary. METHOD: Data from 772 young people in seven European countries participating in the MILESTONE trial were analysed. We analysed and costed healthcare resources used in the 6-month period before and after the service boundary. RESULTS: The proportion of young people engaging with healthcare services fell substantially after crossing the service boundary (associated costs €7761 pre-boundary v. €3376 post-boundary). Pre-boundary, the main cost driver was in-patient care (approximately 50%), whereas post-boundary costs were more evenly spread between services; cost reductions were correlated with pre-boundary in-patient care. Severity was associated with substantially higher costs pre- and post-boundary, and those who were engaged specifically with mental health services after the service boundary accrued the greatest healthcare costs post-service boundary. CONCLUSIONS: Costs of healthcare are large in this population, but fall considerably after transition, particularly for those who were most severely ill. In part, this is likely to reflect improvement in the mental health of young people. However, qualitative evidence from the MILESTONE study suggests that lack of capacity in adult services and young people's disengagement with formal mental health services post-transition are contributing factors. Long-term data are needed to assess the adverse long-term effects on costs and health of this unmet need and disengagement.

Predictors of transitioning to adult mental health services and associated costs: a cross-country comparison.

BACKGROUND: Young people are at risk of falling through the care gap after leaving child and adolescent mental health services (CAMHS) despite an ongoing need for mental health support. Currently, little is known about the predictors of transitioning to adult mental health services (AMHS), and associated healthcare and societal costs as young people cross the transition boundary. OBJECTIVE: To conduct a secondary data analysis exploring predictors of transitioning or falling through the gap and associated costs. METHODS: Data were used from a longitudinal study, which followed young people from seven European countries for 2 years after reaching their CAMHS boundary. Predictors of transitioning (including sociodemographic and clinical variables) and longitudinal resource use were compared for 488 young people who transitioned to AMHS versus those who fell through the gap. FINDINGS: Young people were more likely to transition to AMHS if they were severely ill. Those from Italy, the Netherlands and the UK were more likely to fall through the gap than transition to AMHS. Healthcare costs fell for all young people over the study, with a sharper decrease for those who fell through the gap. CONCLUSIONS: Total healthcare costs fell for all participants, indicating that the intensity of mental health support reduces for all young people as they cross the CAMHS boundary, regardless of clinical need. CLINICAL IMPLICATIONS: It is important that alternative forms of mental health support are available for young people who do not meet the AMHS care threshold but still have mental health needs after leaving CAMHS.

The importance of clinicians' and parents' awareness of suicidal behaviour in adolescents reaching the upper age limit of their mental health services in Europe.

BACKGROUND: To study clinicians' and parents' awareness of suicidal behaviour in adolescents reaching the upper age limit of their Child and Adolescent Mental Health Service (CAMHS) and its association with mental health indicators, transition recommendations and mental health service (MHS) use. METHODS: 763 CAMHS users from eight European countries were assessed using multi-informant and standardised assessment tools at baseline and nine months follow-up. Separate ANCOVA's and pairwise comparisons were conducted to assess whether clinicians' and parents' awareness of young people's suicidal behaviour were associated with mental health indicators, clinician's recommendations to continue treatment and MHS use at nine months follow-up. RESULTS: 53.5 % of clinicians and 56.9 % of parents were unaware of young people's self-reported suicidal behaviour at baseline. Compared to those whose clinicians/parents were aware, unawareness was associated with a 72-80 % lower proportion of being recommended to continue treatment. Self-reported mental health problems at baseline were comparable for young people whose clinicians and parents were aware and unaware of suicidal behaviour. Clinicians' and parents' unawareness were not associated with MHS use at follow-up. LIMITATIONS: Aspects of suicidal behaviour, such as suicide ideation, -plans and -attempts, could not be distinguished. Few young people transitioned to Adult Mental Health Services (AMHS), therefore power to study factors associated with AMHS use was limited. CONCLUSION: Clinicians and parents are often unaware of suicidal behaviour, which decreases the likelihood of a recommendation to continue treatment, but does not seem to affect young people's MHS use or their mental health problems.

Parental involvement in the war in Croatia 1991-1995 and suicidality in Croatian male adolescents.

AIM: To investigate the association between parental war involvement and different indicators of psychosocial distress in a community sample of early adolescents ten years after the war in Croatia 1991-1995. METHODS: A total of 695 adolescents were screened with a self-report questionnaire assessing parental war involvement, sociodemographic characteristics, and alcohol and drug consumption. Personality traits were assessed with the Junior Eysenck Personality Questionnaire; depressive symptoms with the Children's Depression Inventory (CDI); and unintentional injuries, physical fighting, and bullying with the World Health Organization survey Health Behavior in School-aged Children. Suicidal ideation was assessed with three dichotomous items. Suicidal attempts were assessed with one dichotomous item. RESULTS: Out of 348 boys and 347 girls who were included in the analysis, 57.7% had at least one veteran parent. Male children of war veterans had higher rates of unintentional injuries (odds ratio [OR], 1.2; 95% confidence interval [CI], 0.56 to 2.63) and more frequent affirmative responses across the full suicidal spectrum (thoughts about death - OR, 2.1; 95% CI, 1.02 to 4.3; thoughts about suicide - OR, 5; 95% CI, 1.72 to 14.66; suicide attempts - OR, 3.6; 95% CI, 1.03 to 12.67). In boys, thoughts about suicide and unintentional injuries were associated with parental war involvement even after logistic regression. However, girls were less likely to be affected by parental war involvement, and only exhibited signs of psychopathology on the CDI total score. CONCLUSION: Parental war involvement was associated with negative psychosocial sequels for male children. This relationship is possibly mediated by some kind of identification or secondary traumatization. Suicidality and unintentional injuries are nonspecific markers for a broad range of psychosocial distresses, which is why the suggested target group for preventive interventions should be veteran parents as vectors of this distress.

Leaving child and adolescent mental health services in the MILESTONE cohort: a longitudinal cohort study on young people's mental health indicators, care pathways, and outcomes in Europe.

BACKGROUND: The configuration of having separate mental health services by age, namely child and adolescent mental health services (CAMHS) and adult mental health services (AMHS), might be a barrier to continuity of care that adversely affects young people's mental health. However, no studies have investigated whether discontinuity of care in the transition period affects mental health. We aimed to discern the type of care young people receive after reaching the upper age limit of their CAMHS and examine differences in outcomes at 24-month follow-up between young people receiving different types of care. METHODS: To assess mental health in young people from 39 CAMHS in eight European countries (Belgium, Croatia, France, Germany, Italy, Ireland, the Netherlands, and the UK), we did a longitudinal cohort study. Eligible young people were CAMHS users up to 1 year younger than the upper age limit of their CAMHS or up to 3 months older, if they were still in CAMHS. Information on mental health service use, mental health problems (ie, using the Health of the Nation Outcome Scale for Children and Adolescents, Youth Self-Report and Adult Self-Report, DSM-5, and ICD-10), and sociodemographic characteristics were collected using self-reported, parent-reported, and clinician-reported interviews and questionnaires. Mixed models were applied to assess relationships between baseline characteristics, mental health service use, and outcomes. FINDINGS: The MILESTONE cohort included 763 young people. The participants were 60·0% female (n=458) and 40·0% male (n=305), 90·3% White (n=578), and had a mean age of 17·5 years (range 15·2-19·6 years). Over the 24-month follow-up period, 48 young people (6·3%) actively withdrew from the study. For young people, the higher their scores on the Health of the Nation Outcome Scale for Children and Adolescents (p=0·0009) and Youth Self-Report and Adult Self-Report (p=0·046), and who had a clinical classification of severe mental illness (p=0·0033), had suicidal thoughts or behaviours or self-harm (p=0·034), used psychotropic medication (p=0·0014), and had a self-reported or parent-reported need for continued treatment (p<0·0001) at baseline, were more likely to transition to AMHS or stay in CAMHS than to have care end. Overall, over the 24-month follow-up period, the mental health of young people improved, but 24·4% of young people reported an increase in problems calculated using the reliable change index, of whom 5·3% had a clinically relevant increase in problems. At 24-month follow-up, no differences in change in mental health problems since baseline were found between young people who used different types of care (CAMHS, AMHS, or no care). INTERPRETATION: Although approximately half of young people reaching the upper age limit of their CAMHS stop using mental health services, this was not associated with a deterioration in their mental health. Young people with the most severe mental health problems are more likely to receive continued care. If replicated, our findings suggest investments in improving transitional care for all CAMHS users might not be cost-effective in times of rising health-care costs, but might be better targeted at a subgroup of young people with increasing mental health problems who do not receive continued treatment. FUNDING: European Commission's 7th Framework Programme.