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Abstract Aim of the study Artificial intelligence (AI) chatbots are established as tools for answering medical questions worldwide. Healthcare trainees are increasingly using this cutting-edge technology, although its reliability and accuracy in the context of healthcare remain uncertain. This study evaluated the suitability of Chat-GPT versions 3.5 and 4 for healthcare professionals seeking up-to-date evidence and recommendations for resuscitation by comparing the key messages of the resuscitation guidelines, which methodically set the gold standard of current evidence and recommendations, with the statements of the AI chatbots on this topic. Methods This prospective comparative content analysis was conducted between the 2021 European Resuscitation Council (ERC) guidelines and the responses of two freely available ChatGPT versions (ChatGPT-3.5 and the Bing version of the ChatGPT-4) to questions about the key messages of clinically relevant ERC guideline chapters for adults. (1) The content analysis was performed bidirectionally by independent raters. The completeness and actuality of the AI output were assessed by comparing the key message with the AI-generated statements. (2) The conformity of the AI output was evaluated by comparing the statements of the two ChatGPT versions with the content of the ERC guidelines. Results In response to inquiries about the five chapters, ChatGPT-3.5 generated a total of 60 statements, whereas ChatGPT-4 produced 32 statements. ChatGPT-3.5 did not address 123 key messages, and ChatGPT-4 did not address 132 of the 172 key messages of the ERC guideline chapters. A total of 77% of the ChatGPT-3.5 statements and 84% of the ChatGPT-4 statements were fully in line with the ERC guidelines. The main reason for nonconformity was superficial and incorrect AI statements. The interrater reliability between the two raters, measured by Cohen’s kappa, was greater for ChatGPT-4 (0.56 for completeness and 0.76 for conformity analysis) than for ChatGPT-3.5 (0.48 for completeness and 0.36 for conformity). Conclusion We advise healthcare professionals not to rely solely on the tested AI-based chatbots to keep up to date with the latest evidence, as the relevant texts for the task were not part of the training texts of the underlying LLMs, and the lack of conceptual understanding of AI carries a high risk of spreading misconceptions. Original publications should always be considered for comprehensive understanding.

Abstract Background Family caregivers of terminally ill and dying people do not only experience varying levels but also different dimensions of caregiver-related strain and burden. The aim of the study was to develop a short multidimensional screening tool for the detection of burden in family caregivers in palliative care. Methods Family caregivers of cancer patients newly admitted to specialist inpatient palliative care (N = 232) completed questionnaires on psychological burden, quality of life, social support and need fulfillment. A latent class mixture model was used to identify discrete classes of family caregivers related to their multidimensional caregiver burden. Multinomial logistic regression analyses were performed to identify the most predictive items from a set of established questionnaires. Results Four latent classes of family caregivers were identified: Currently stable caregivers (37%), Caregivers with unmet needs (20%), Psychologically burdened caregivers (30%), and High-risk caregivers (13%). Each of these classes describes a different risk profile of multidimensional family caregiver burden, although family caregivers exhibit high levels of distress across all classes. From a set of 48 items, we identified eight items that predicted the class membership best. These items represent the items of the novel multidimensional screening tool: The 8-item Screening Tool for Family Caregiver Burden in Palliative Care (CAREPAL-8). Except for social support, the items maintained fidelity to the conceptualization of multidimensional caregiver burden used in this study. A preliminary classification system was developed, which has yet to be validated. Conclusions This study represents the first step in the establishment of a practical, self-administered screening tool that might help healthcare providers to tailor caregiver care according to their burden in daily practice. Brevity of the 8-item tool might facilitate its use in routine clinical care.

Abstract Background The prognosis for patients improves significantly with effective cardiopulmonary resuscitation (CPR) performed by bystanders. Current research indicates that individuals who receive CPR from trained bystanders have a greater likelihood of survival compared to those who receive dispatcher-assisted CPR from untrained laypersons. This cluster-randomised controlled trial assessed the impact of a 30-min online training session prior to a simulated cardiac arrest situation with dispatcher-assisted CPR (DA-CPR) on enhancing Basic Life Support (BLS) performance. Methods This study was performed in 2018 in Hamburg, Germany. The primary outcome was the practical BLS skills of high school students in simulated out-of-hospital cardiac arrest scenarios with dispatcher assistance. The intervention group participants underwent a 30-min online BLS training session, while the control group did not receive an intervention. It was hypothesized that the average practical BLS scores of the intervention group would be 1.5 points higher than those of the control group. Results BLS assessments of 286 students of 16 different classes were analysed. The estimated mean BLS score in the intervention group was 7.60 points (95% CI: 6.76 to 8.44) compared to 6.81 (95% CI: 5.97 to 7.65) in the control group adjusted for BLS training and class. Therefore, the estimated mean difference between the groups was 0.79 (95% CI: -0.40 to 1.97) and not significantly different (p-value: 0.176). Based on a logistic regression analysis the intervention had only a significant effect on the chance to pass the item “vertically above the chest” (OR = 4.99; 95% CI: 1.46 to 17.12) adjusted for BLS training and class. Conclusion Prior online training exhibits beneficial impacts on the BLS performance of bystanders during DA-CPR. To maximise the effect size, online training should be incorporated into a set of interventions that are mutually complementary and specifically designed for the target participants. Trial registration DRKS00033531 . "Kann online Training Laien darauf vorbereiten Reanimationsmaßnahmen unter Anleitung der Leitstelle adäquat durchzuführen? " Registered on January 29, 2024.

BackgroundDuring adolescence, substance use and digital media exposure usually peak and can become major health risks. Prevention activities are mainly implemented in the regular school setting, and youth outside this system are not reached. A mobile app (“Meine Zeit ohne”) has been developed specifically for vocational students and encourages participants to voluntarily reduce or abstain from a self-chosen addictive behavior including the use of a substance, gambling, or a media-related habit such as gaming or social media use for 2 weeks. Results from a randomized study indicate a significant impact on health-promoting behavior change after using the app. This exploratory study focuses on the intervention arm of this study, focusing on acceptance and differential effectiveness. ObjectiveThe aims of this study were (1) to examine the characteristics of participants who used the app, (2) to explore the effectiveness of the mobile intervention depending on how the app was used and depending on participants’ characteristics, and (3) to study how variations in app use were related to participants’ baseline characteristics. MethodsLog data from study participants in the intervention group were analyzed including the frequency of app use (in days), selection of a specific challenge, and personal relevance (ie, the user was above a predefined risk score for a certain addictive behavior) of challenge selection (“congruent use”: eg, a smoker selected a challenge related to reducing or quitting smoking). Dichotomous outcomes (change vs no change) referred to past-month substance use, gambling, and media-related behaviors. The relationship between these variables was analyzed using binary, multilevel, mixed-effects logistic regression models. ResultsThe intervention group consisted of 2367 vocational students, and 1458 (61.6%; mean age 19.0, SD 3.5 years; 830/1458, 56.9% male) of them provided full data. Of these 1458 students, 894 (61.3%) started a challenge and could be included in the analysis (mean 18.7, SD 3.5 years; 363/894, 40.6% female). Of these 894 students, 466 (52.1%) were considered frequent app users with more than 4 days of active use over the 2-week period. The challenge area most often chosen in the analyzed sample was related to social media use (332/894, 37.1%). A total of 407 (45.5%) of the 894 students selected a challenge in a behavioral domain of personal relevance. The effects of app use on outcomes were higher when the area of individual challenge choice was equal to the area of behavior change, challenge choice was related to a behavior of personal relevance, and the individual risk of engaging in different addictive behaviors was high. ConclusionsThe domain-specific effectiveness of the program was confirmed with no spillover between behavioral domains. Effectiveness appeared to be dependent on app use and users’ characteristics. Trial RegistrationGerman Clinical Trials Register DRKS00023788; https://tinyurl.com/4pzpjkmj International Registered Report Identifier (IRRID)RR2-10.1186/s13063-022-06231-x

Abstract Βackground Children of parents with a mental illness have up to 50% chance of developing a mental illness themselves. Numerous studies have shown that preventive family-oriented interventions can decrease the risk by 40% and that professionals are a decisive factor influencing family-oriented practice. There are also substantial differences between professions in terms of their family-oriented practices. This study examines the level of family-oriented practice for different professional groups in Germany. Methods Data were used from the baseline assessment of the two-group randomized controlled multicenter trial ci-chimps as a subproject of CHIMPS-NET, which took place from January 2020 to May 2021 in 18 clinical centers in Germany. Child and adolescent mental health systems as well as adult mental health systems took part and every professional involved in the treatment was invited to participate. Data was used from 475 mental health professionals including physicians, psychologists, psychotherapists for adults and for children and adolescents, occupational/ music/ physio/ art therapists/ (social) education workers and nursing/ education service. Family-oriented mental health practice was examined using the translated version of the Family-Focused Mental Health Practice Questionnaire (FFMHPQ) with means and standard deviations calculated for each of the 18 FFMHPQ-GV subscales. ANOVAs were computed to compare professions and significant differences were examined via post hoc analyses (Scheffé). Additionally, effect sizes were calculated (Omega squared). Results Differences were seen between the professions in all aspects of family-oriented practice: Both regarding organizational policy and support aspects, issues concerning working with parent-clients, as well as professional skills and knowledge aspects. Psychotherapists for children and adolescents scored the highest family-oriented practices compared to all other professional groups on almost all subscales. Conclusion This study examines the level of family-oriented practice for different professional groups in Germany. Apart from skills and knowledge about the impact of mental illness and parenting, psychotherapists for children and adolescents had the highest scores and engaged most in family-oriented practice. Psychotherapists for adults got the least workplace support for family-oriented practice but were competent providing resources and referral information to the concerned families and feel confidence working with them. Due to these results, a training need exists to improve skills and knowledge about the impact of mental illness and parenting. Additionally, there is still potential for institutional support in promoting family-oriented work. Trial registration The CHIMPS-NET-study was registered with the German Clinical Trials Register on 2019–12-19 (DRKS00020380) and with Clinical Trials on 2020–4-30 (NCT04369625), the ci-chimps-study was registered with the German Clinical Trials Register (DRKS00026217) on 2021–08-27 and with Clinical Trials on 2021–11-04 (NCT05106673).

IntroductionSchizophrenia-Spectrum-Disorders are associated with poor long-term outcome as well as disability and often severely affect the lives of patients and their families often from symptom onset. Up to 70% of first episode psychosis (FEP) patients suffer from comorbid substance use disorders (SUD). We aimed at studying the course of illness in FEP patients within evidence-based care, with and without comorbid SUD, to examine how decreased, remitted or persistent substance use impacted rates of a combined symptomatic and functional long-term recovery compared with patients without SUD.MethodsACCESS III is an integrated care model for FEP or patients in the early phase of non-affective and affective psychotic disorders. Treatment trajectories of patients, who had been in ACCESS care for 1 year, with and without SUD were compared with regard to the course of illness and quality of life using Mixed Model Repeated Measures (MMRM) and recovery rates were compared using binary logistic regression. Change in substance use was coded as either persistent, decreased/remitted or no use.ResultsACCESS III was a prospective 1-year study (N = 120) in patients aged 12–29 years. Of these, 74 (61.6%) had a comorbid SUD at admission. There were no group differences regarding the course of illness between patients with or without comorbid SUD or between patients with a substance abuse or substance dependence. The only outcome parameter that was affected by SUD was quality of life, with larger improvement found in the group without substance use (p = 0.05) compared to persistent and remitted users. Using LOCF, 44 patients (48.9%) fulfilled recovery criteria at the endpoint; recovery did not differ based on substance use status.DiscussionSUD and especially substance dependence are common in psychotic disorders even in FEP patients. Evidence-based integrated care led to long-term improvement in patients with comorbid SUD and rate of recovery did not differ for patients with substance use.

Abstract Background Type 2 diabetes mellitus (T2DM) is a major health problem in the western world. Despite a widespread implementation of integrated care programs there are still patients with poorly controlled T2DM. Shared goal setting within the process of Shared Decision Making (SDM) may increase patient’s compliance and adherence to treatment regimen. In our secondary analysis of the cluster-randomized controlled DEBATE trial, we investigated if patients with shared vs. non-shared HbA1c treatment goal, achieve their glycemic goals. Methods In a German primary care setting, we collected data before intervention at baseline, 6, 12 and 24 months. Patients with T2DM with an HbA1c ≥ 8.0% (64 mmol/mol) at the time of recruitment and complete data at baseline and after 24 months were eligible for the presented analyses. Using a generalized estimating equation analysis, we analysed the association between the achievement of HbA1c goals at 24 months based on their shared vs. non-shared status, age, sex, education, partner status, controlled for baseline HbA1c and insulin therapy. Results From N = 833 recruited patients at baseline, n = 547 (65.7%) from 105 General Practitioners (GPs) were analysed. 53.4% patients were male, 33.1% without a partner, 64.4% had a low educational level, mean age was 64.6 (SD 10.6), 60.7% took insulin at baseline, mean baseline HbA1c was 9.1 (SD 1.0). For 287 patients (52.5%), the GPs reported to use HbA1c as a shared goal, for 260 patients (47.5%) as a non-shared goal. 235 patients (43.0%) reached the HbA1c goal after two years, 312 patients (57.0%) missed it. Multivariable analysis shows that shared vs. non-shared HbA1c goal setting, age, sex, and education are not associated with the achievement of the HbA1c goal. However, patients living without a partner show a higher risk of missing the goal (p = .003; OR 1.89; 95% CI 1.25–2.86). Conclusions Shared goal setting with T2DM patients targeting on HbA1c-levels had no significant impact on goal achievement. It may be assumed, that shared goal setting on patient-related clinical outcomes within the process of SDM has not been fully captured yet. Trial registration The trial was registered at ISRCTN registry under the reference ISRCTN70713571.

BackgroundHealth behaviors in persons with multiple sclerosis (pwMS) have been associated with MS-related disease outcomes.ObjectiveThe aim of the study was to gain knowledge about current patient health behaviors in a convenience sample representative for pwMS presenting to a large university-based outpatient clinic and to investigate associations between modifiable risk factors with physical impairment, quality of life (QoL) and cardiovascular comorbidities.MethodsA questionnaire was administered at the MS Outpatient Clinic of the University Medical Center Hamburg Eppendorf asking for health behaviors regarding dietary habits assessed with the German adaptation of the validated Spanish short Diet Quality Screener (sDQS), level of physical activity assessed with the Godin Leisure Time Questionnaire (GLTEQ) and tobacco smoking. Participants were asked to report cardiovascular comorbidities using items from the Self-Report Comorbidity Questionnaire for Multiple Sclerosis. Additionally, cardiovascular risk factors like blood pressure, height and weight (to calculate BMI) and waist circumference were measured. MS specific clinical data, e.g., disease course, duration, disability and MS-specific QoL were collected from the clinical database. Descriptive analyses were performed and multivariate regression analyses for complete cases were carried out for each of the three outcome variables including all mentioned modifiable risk factors (dietary behavior, smoking, physical activity and BMI) as independent variables.ResultsIn this sample of 399 pwMS the mean age was 42 years (SD 12.8) with a mean disease duration since diagnosis of 7.4 years (SD 8.4) and a mean EDSS of 2.8 (SD 1.9). 24% were current smokers, 44% were insufficiently physically active and 54% did not follow a healthy dietary pattern. 49% of this relatively young clinical population was overweight and 27% reported one or more cardiovascular comorbidities. Most modifiable risk factors showed no convincing associations with MS-related disease outcomes in the multiple regression analyses.ConclusionThis clinical cohort of pwMS shows a high prevalence of critical health behaviors and comorbidities and emphasizes the need for monitoring, education and assistance for behavior change in this population.

Abstract Background Advances in genetic and pharmaceutical technology and pediatric care have enabled treatment options for an increasing number of rare diseases in affected children. However, as current treatment options are primarily of palliative nature, the Health-Related Quality of Life (HRQoL) and mental health of this impaired population and their siblings are of increasing importance. Among children and adolescents with rare diseases, those who are technology-dependent carry a high disease burden and are selected as the target population in our study. In a cross-sectional observational design, the children’s HRQoL was assessed with the DISABKIDS (DCGM-37) as well as KIDSCREEN-27, while mental health was assessed with the Strengths and Difficulties Questionnaire (SDQ) by both the affected children, their parents, and siblings. Results Results of the study sample were compared to normative data. Affected children scored significantly lower than the norm on almost all HRQoL subscales as reported by parent and child. From the parental perspective, more mental health subscales were significantly impaired compared to the child’s perspective. Siblings showed no impairment in HRQoL as well as significantly fewer behavioral problems and higher prosocial behavior regarding their mental health compared to the norm. Conclusion Children and adolescents with rare diseases seem particularly impaired in social and emotional aspects of HRQoL and mental health. Interventions may focus primarily on promoting social skills, fostering prosocial behavior and peer relationships.

Abstract Purpose Studies on outcomes mapping Quality of Life (QoL) as patient-reported outcome over a longer period in severe psychotic disorders are scarce. However, such data would be particularly important for structuring, implementing and operating effective and efficient care models and for promoting satisfaction with care, service engagement and adherence. Methods The ACCESS II study is a prospective long-term study of an integrated care model for people with severe psychotic disorders. The model includes Therapeutic Assertive Community Treatment within a cross-sectoral and interdisciplinary network. This publication analyses the course of QoL assessed with the Q-LES-Q-18 using a mixed model for repeated measures. Results Mapping the course of QoL in N = 329 participants, there is a significant increase in the first 6 weeks of treatment (early course). Comparison to a published norm show significant lower QoL for severe psychotic disorders. The variable having a traumatic event before the age of 18 was significantly negatively associated with QoL. A decrease in the severity of depressive as well as in positive symptomatology in the first six weeks after admission was associated with increase of QoL. Conclusion Results indicate that the overall symptom burden at time of inclusion is not decisive for the perceived QoL in the long-term course while the reduction in the severity of depressive and positive symptoms is important. This means focusing even more on the treatment of depressive symptoms and include traumatherapeutic aspects in the long-term treatment of severe psychotic disorders if needed. Trail registration ClinicalTrials.gov (identifier: NCT01888627).

Purpose: Research shows that persons with mild to moderate multiple sclerosis are less physically active than healthy controls even though they would benefit from it. This study focusses on the feasibility testing and process evaluation of the pilot study of ActivityMatters, a twelve-week web-based program, from Ireland, to increase physical activity in this population. Materials and Methods: The intervention was adapted to local circumstances in Hamburg, Germany and consists of eleven modules incorporating behavior change techniques. After feasibility had been confirmed, 43 persons with multiple sclerosis participated in a pilot study with a pre-post, single-group intervention design. Qualitative data was collected with questionnaires and semi structured interviews. Physical activity level and stage of change was measured quantitatively. Results: Participants had a mean age of 49.5 years (SD 9.29) and an average Patient Determined Disease Step Score of 2.2 (SD 1.47). Thirty-six participants answered the follow-up questionnaire. On average 9.8 modules were processed within 13 weeks. Each tool for behavior change was perceived as helpful except the chat group. Physical activity levels increased significantly from pre- to post intervention (p-value 0.042, Cohen's d = 0.35). Conclusions: The results indicate that Activity Matters is feasible and satisfactory and may change activity levels. IMPLICATIONS FOR REHABILITATION: Activity Matters provides a twelve-week web-based self-management program to increase PA which is feasible and well accepted by middle aged, mild to moderately impaired persons with MS. Persons with MS in this online program were pleased with the overall content and the self-regulation strategies, however some were seeking for more personal contact and interaction with the study team and other participants. Stronger individualisation of web-based programs to the diverse needs of participants remains a challenge that has to be solved in the future. [ABSTRACT FROM AUTHOR]

ObjectivePeople with intellectual disabilities (ID) are at higher risk of being sexually abused and developing psychiatric disorders in consequence. The effects of behavior prevention programs for children with ID have rarely been investigated. Previous studies suffer from methodical weaknesses, such as the lack of a control group, small sample size, or invalid outcome measures. This study aimed at demonstrating the efficacy of a prevention program by overcoming these flaws.MethodsA group prevention program was developed and evaluated. One hundred and six girls aged from 8 to 12 years with mild ID were enrolled in a randomized controlled study, comparing the training to a sham intervention. Effects were examined in a three-time follow-up design as individual changes in preventive knowledge (board game, verbal reports) and preventive behavior (role-play, in situ tests). Participants' behaviors were videotaped and rated by three blinded raters.ResultsGirls from the intervention group (n = 64) showed significant improvements in preventive knowledge compared with the control group (n = 39) but showed non-significant improvements for preventive behavior. In situ tests with realistic seduction situations revealed no improvement. The intervention proved to be safe, but several risks need to be considered.DiscussionThis is the first study that evaluates a behavioral prevention program on sexual abuse for children with ID on a high level of evidence. Group interventions empowering girls with ID to recognize abuse situations are suitable to enhance sexual preventive knowledge but are less suitable to enhance preventive behavior. Naturalistic settings are indispensable for providing evidence for preventive interventions in children with ID.

Abstract Background We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus? Methods We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline. Results Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p

Abstract Background Early hypercapnia is common in patients with acute respiratory distress syndrome (ARDS) and is associated with increased mortality. Fluctuations of carbon dioxide have been associated with adverse neurological outcome in patients with severe respiratory failure requiring extracorporeal organ support. The aim of this study was to investigate whether early hypercapnia is associated with impaired cerebrovascular autoregulation during the acute phase of ARDS. Methods Between December 2018 and November 2019, patients who fulfilled the Berlin criteria for ARDS, were enrolled. Patients with a history of central nervous system disorders, cerebrovascular disease, chronic hypercapnia, or a life expectancy of less than 24 h were excluded from study participation. During the acute phase of ARDS, cerebrovascular autoregulation was measured over two time periods for at least 60 min. Based on the values of mean arterial blood pressure and near-infrared spectroscopy, a cerebral autoregulation index (COx) was calculated. The time with impaired cerebral autoregulation was calculated for each measurement and was compared between patients with and without early hypercapnia [defined as an arterial partial pressure of carbon dioxide (PaCO2) ≥ 50 mmHg with a corresponding arterial pH

Abstract Background Children of parents with mental illness have a higher risk of developing mental health problems when compared with the general population. Therefore, families with parents with mental illness are a suitable target group for selective prevention. In order to plan and evaluate the health economic consequences of preventive interventions for this target group, data on the societal costs related to parenthood under the condition of mental disorders are needed. To date, within Germany there has been a lack of research evaluating the costs of mental health treatment and use of social services by children and adolescents with parents with mental illness. Methods As part of a multicentre randomised controlled trial, use and costs of health and social services were assessed for a sample of 332 children and adolescents with parents with mental illness in six regions of Germany. Service use at baseline was assessed by the German version of the Children and Adolescent Mental Health Service Receipt Inventory. Costs were calculated for 12 months based on diagnosis and service user status and described separately. Cost drivers were identified by means of a two-part regression model. Results Total mean costs for 12 months for the total sample amount of € 3736.35 (95% CI: € 2816.84–4813.83) per person. Children with a psychiatric diagnosis generated a total of € 5691.93 (95% CI: € 4146.27–7451.38) of costs per person, compared to € 1245.01 (95% CI: € 657.44–1871.49) for children without a psychiatric diagnosis. The logit part indicates significant odds ratios for individual functioning and diagnosis of the child as well as for family functioning. The linear part reveals that increasing individual functioning in the child is related to decreasing costs. Conclusions Children of families with parents with mental illness use a broad spectrum of mental health care, school-based support and youth welfare services even if they are not yet diagnosed as having a mental disorder. Further research should examine whether these institutions are sufficiently qualified and interlinked to meet the support needs of this vulnerable group. Trial registration The study was registered at the 07/10/2014 before the start of data collection (04/11/2014) at the German clinical trials register (Deutsches Register Klinischer Studien, DRKS, nr: DRKS00006806, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00006806 ).

Abstract Background Families of children with rare diseases (i.e., not more than 5 out of 10,000 people are affected) are often highly burdened with fears, insecurities and concerns regarding the affected child and its siblings. Although families caring for children with rare diseases are known to be at risk for mental disorders, the evaluation of special programs under high methodological standards has not been conducted so far. Moreover, the implementation of interventions for this group into regular care has not yet been accomplished in Germany. The efficacy and cost-effectiveness of a family-based intervention will be assessed. Methods/design The study is a 2x2 factorial randomized controlled multicenter trial conducted at 17 study centers throughout Germany. Participants are families with children and adolescents affected by a rare disease aged 0 to 21 years. Families in the face-to-face intervention CARE-FAM, online intervention WEP-CARE or the combination of both will be treated over a period of roughly 6 months. Topics discussed in the interventions include coping, family relations, and social support. Families in the control condition will receive treatment as usual. The primary efficacy outcome is parental mental health, measured by the Structured Clinical Interview for DSM-IV (SCID-I) by blinded external raters. Further outcomes will be assessed from the parents’ as well as the children’s perspective. Participants are investigated at baseline, 6, 12 and 18 months after randomization. In addition to the assessment of various psychosocial outcomes, a comprehensive health-economic evaluation will be performed. Discussion This paper describes the implementation and evaluation of two family-based intervention programs for Children Affected by Rare Disease and their Family’s Network (CARE-FAM-NET) in German standard care. A methodologically challenging study design is used to reflect the complexity of the actual medical care situation. This trial could be an important contribution to the improvement of care for this highly burdened group. Trial registration German Clinical Trials Register: DRKS00015859 (registered 18 December 2018) and ClinicalTrials.gov : NCT04339465 (registered 8 April 2020). Protocol Version: 15 August 2020 (Version 6.1). Trial status: Recruitment started on 1 January 2019 and will be completed on 31 March 2021.

Abstract Background The Kids save lives statement recommends annual Basic Life Support (BLS) training for school children but the implementation is challenging. Trainings should be easy to realise and every BLS training should be as effective as possible to prepare learners for lifesaving actions. Preparedness implies skills and positive beliefs in the own capability (high self-efficacy). Methods This randomized controlled cluster study investigates, if self-regulated learning promotes self-efficacy and long-term retention of practical BLS skills. Students in the age of 12 years participated in a practical training in BLS and a scenario testing of skills. In the control group the practical training was instructor-led. In the intervention group the students self-regulated their learning processes and feedback was provided by the peer-group. The primary outcome self-efficacy for helping in cardiac arrest after the training and 9 months later was analysed using a multilevel mixed model. Means and pass-rates for BLS skills were secondary outcomes. Results Contrary to the assumptions, this study could not measure a higher self-efficacy for helping in cardiac arrest of the students participating in the intervention (n = 307 students) compared to the control group (n = 293 students) after training and at the follow-up (mean difference: 0.11 points, 95% CI: − 0.26 to 0.04, P = 0.135). The odds to pass all items of the BLS exam was not significantly different between the groups (OR 1.11, 95% CI: 0.81 to 1.52, p = 0.533). Self-regulated learning was associated with a higher performance of male students in the BLS exam (mean score: 7.35) compared to females of the intervention (female: 7.05) and compared to males of the control (7.06). Conclusion This study could not resolve the question, if self-regulated learning in peer-groups improves self-efficacy for helping in cardiac arrest. Self-regulated learning is an effective alternative to instructor-led training in BLS skills training and may be feasible to realise for lay-persons. For male students self-regulated learning seems to be beneficial to support long-term retention of skills. Trial registration ISRCTN17334920, retrospectively registered 07.03.2019.

Abstract Background Mindfulness training (MT) for parents of adolescents has been shown to improve mental health and stress-related outcomes in individuals and their families. Studies of MT among young people are mainly delivered in educational or clinical settings, and there is a need for controlled studies on both parent-directed and adolescent-directed approaches. It is unclear whether MT has preventive effects for substance use outcomes. The primary objective of this trial is to evaluate the effectiveness of family-based MT targeting both adolescents and their parents to prevent adolescent substance use and enhance neurobehavioral self-regulation skills that play a major role in addiction development and mental health. Methods/design The trial design is a superiority, two-arm, randomized controlled trial in which families will participate either in the full curriculum of the evidence-based Strengthening Families Program 10–14 (SFP 10–14, German adaptation) or in a mindfulness-enhanced version of this program (SFP-Mind). Both seven-session interventions are highly structured and will each be delivered over a period of approximately 7 weeks. The experimental intervention SFP-Mind is a modified version of the SFP 10–14 in which some elements were eliminated or changed to enable the inclusion of additional parent-directed and adolescent-directed mindfulness components. The primary outcome is adolescent self-reported alcohol use based on an alcohol initiation index at 18-month follow-up. Dispositional mindfulness, impulsivity, and emotion regulation will be included as secondary outcomes and potential mechanisms of action. The study will recruit and randomize 216 adolescents, aged 10–14 years, and their parents who will be followed up for 18 months. Discussion This trial aims to evaluate the effectiveness of SFP-Mind for family-based prevention of substance use and promoting mental health in adolescence. Trial registration German Register of Clinical Studies, DRKS00015678. Registered on 25 February 2019.

IntroductionChildren of parents with mental disorders have a high chance of developing a mental disorder themselves. However, this at-risk group is regularly overlooked and typically not seen by any mental health professionals. Internet- and mobile-based interventions (IMIs) can provide a means of promoting mental health for children of parents with mental disorders.ObjectiveThe introduced study will evaluate the clinical- and cost-effectiveness of the iCHIMPS IMI in promoting mental health for children of parents with mental disorders.MethodsA two-armed multicentered cluster-randomized controlled trial (cRCT) comparing the clinical- and cost-effectiveness of the iCHIMPS IMI in the intervention group (IG) to a treatment-as-usual (TAU) control group will be conducted. Recruitment will be handled at currently 21 adult mental health clinics throughout Germany. Participating families will be randomly divided into the two groups until the final sample size of 306 participating adolescents (age 12–18) has been reached. The adolescents in the intervention group will receive access to the IMI and can take part in up to eight intervention modules. Assessment will be conducted during the recruitment (baseline), 1-month, 2-months, and 6-month post-inclusion. Primary outcome is the mental health of the participating adolescents at 6-months post-inclusion as measured by the Youth Self Report score. Secondary self-report outcomes are mental wellbeing, self-efficacy, coping strategies and negative effects as well as mental health of the adolescents as reported by their parent(s). Included moderators are sociodemographic characteristics, working alliance, social support and the mental health diagnoses of the parents. Statistical analyses will be conducted on the intention-to-treat principle as well as with additional per-protocol analyses. Additionally, the cost-effectiveness as well as qualitative data concerning the adherence, acceptance, and feasibility of the IMI will be analyzed.DiscussionThe iCHIMPS cRCT examines the clinical- as well as cost-effectiveness of the iCHIMPS mental health promotion IMI for children of parents with mental disorders. This provides the opportunity to gain insights into an innovative as well as time- and location-independent form of support for this often-overlooked at-risk group. Additionally, the larger CHIMPS-NET project allows comparisons between internet-based and face-to-face interventions for a similar target group.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier: DRKS00025158.

BackgroundIn Germany, approximately three million children under the age of eighteen have a mentally ill parent. These children are at an increased risk of developing a mental illness themselves (1) as well as a physical illness (2). While research has identified numerous evidence-based family-oriented interventions, little is known about how to implement such interventions effectively and efficiently in clinical practice in Germany. This implementation study (ci-chimps) evaluates three clinical implementation projects with three different implementation interventions for the optimal implementation of the tailored family-oriented preventive and therapeutic interventions in the CHIMPS-NET (children of mentally ill parents—research network) with an implementation model for children of mentally ill parents.MethodsA two-group randomized controlled multicenter trial will examine changes in family-oriented practice and aspects of implementation at baseline as well as at 12- and 24-months follow-up. The CHIMPS-Network consists of 20 clinical centers. The centers in the intervention group receive the support of all of the three implementation interventions: (1) optimal pathways to care, (2) education and a training program for professionals, and (3) systematic screening for children. The centers in the control group do not receive this specific implementation support.DiscussionWhile we know that children of mentally ill parents are an important target group to be addressed by preventive and therapeutic interventions, there is often a lack of structured implementation of family-oriented interventions in clinical practice in Germany. Using a randomized controlled multicenter trial design with a large and wide-ranging sample (clinics for adult psychiatry and clinics for child and adolescent psychiatry, university clinics and clinics at the real health care) will provide a robust understanding of implementing family-oriented changes in German clinical practice.Trial RegistrationThe CHIMPS-NET-study was registered with the German Clinical Trials Register on 2019-12-19 (DRKS00020380) and with Clinical Trials on 2020-4-30 (NCT04369625), the ci-chimps-study was registered with the German Clinical Trials Register (DRKS00026217) on 2021-08-27, the Clinical Trials registration is in review process.

Purpose: Health-related quality of life (HRQoL) can be reduced in parents with mental illness (mental illness) who face the dual demands of disabling symptoms and their impact on family, social, and occupational life. This study aimed at analyzing the influence of various factors on HRQoL in parents with mental illness.Method: Baseline data of the German randomized controlled multicenter project CHIMPS (children of parents with mental illness) was used for analyses. The final sample consisted of n = 208 parents with mental illness and n = 197 children and adolescents aged 8–18 years. HRQoL was assessed with the EQ-5D.Results: Parents with mental illness reported significantly lower global and specific HRQoL than the German reference population. They were least satisfied with aspects that relate to anxiety and depression followed by usual activities, pain and discomfort. Better global HRQoL was primarily associated with self-reported physical and mental health, as well as adaptive coping behavior. Associations with mobility, self-care, usual activity, pain and discomfort, anxiety and depression were analyzed and discussed.Conclusions: HRQoL in parents with mental illness is reduced. Clinical interventions should focus on the alleviation of mental health symptoms and probably somatic symptoms and promote adaptive coping skills.

The relevance of coping behavior for the individual's own mental health has been widely investigated. However, research on the association between coping of parents with a mental illness and their children's mental health is scarce. In the current study, we address the role of several parental coping strategies and their relation to child psychological symptoms. As part of the German randomized controlled multicenter study CHIMPS (children of mentally ill parents), parents with mental illness completed questionnaires on illness-related coping and child mental health symptoms. Children's diagnoses of a mental disorder were assessed with diagnostic interviews. The sample comprised n = 195 parents with mental illness and n = 290 children and adolescents aged 4–18 years. We conducted mixed models to investigate the associations of parental coping strategies with internalizing and externalizing symptoms as well as the diagnosis of a mental disorder in children controlling for sociodemographic factors and parental symptom severity. Parental coping characterized by religiosity and quest for meaning was significantly associated with fewer mental health symptoms and lower odds of a mental disorder in children, whereas a depressed processing style was related to increased internalizing problems in the children. Coping behavior in parents with mental illness is a relevant factor for the mental health of their children and should be considered in preventive interventions.

Offspring of mentally ill parents is at heightened risk for psychological symptoms. The identification of environmental factors that predict their mental health is crucial for the development of preventive and therapeutic measures. In the current study, we addressed the combined role of family functioning and social support by taking mentally ill patients’, their partners’, and children’s perspectives into account. The cross-sectional sample included n=195 families (195 patients, 127 partners, and 295 children). Family members completed questionnaires related to family functioning, social support as well as parental and child psychopathology. We conducted multilevel analyses to investigate the associations with internalizing and externalizing problems in children. Family functioning and social support were significantly associated with child internalizing and externalizing problems. However, results varied depending on the rating perspective. We found significant interaction effects of family functioning and social support on child psychopathology. The findings point to the importance of family functioning and social support as potential targets for interventions. Findings should be replicated in future longitudinal studies.

Children of mentally ill parents represent a particularly vulnerable risk group for the development of mental illness. This study examines whether there is a predictive association between children’s psychiatric symptomatology and (1) the clinical diagnosis according to the International Statistical Classification of Diseases and Related Health Problems (ICD-10) of their mentally ill parent as well as (2) to families both parents showing psychiatric symptoms. The study is part of the multicenter controlled trial project “Children of Mentally Ill Parents” (CHIMPS). For this purpose, the psychiatric symptomatology of the mentally ill parent (N = 196) and his or her partner (N = 134) as well as the psychiatric symptomatology of their children aged 4 to 18 years (N = 290) was measured using clinical rated ICD-10-diagnosis, self-rated Brief Symptom Inventory (BSI), and Child Behavior Checklist (CBCL). Using multilevel analyses, the severity of the parental psychiatric symptomatology (BSI) was identified as a significant predictor of children’s psychiatric symptomatology (CBCL). Children of parents with a personality disorder (ICD-10) were not more affected than children of parents with another ICD-10-diagnosis. However, children with two parents showing psychiatric symptoms (CBCL) were significantly more affected than children with one mentally ill parent. The results of this study support the well-known view that parental mental illness is a risk factor for children’s psychiatric symptoms. Therefore, increased support, especially in high-risk families, both parents having psychiatric symptoms, is highly necessary and should be implemented in the future psychotherapeutic family care.

Objective:Method:Results:Conclusion:To investigate associations between common factors (alliance, insight, problem solving) and therapists’ techniques. We expected a positive association between (1) supportive techniques and the alliance, (2) interpretative techniques and insight, and (3) a stronger association between interpretative techniques and insight for patients with more severe baseline symptoms. Other associations were analyzed in an exploratory way.Sixty sessions from 15 adult female patients diagnosed with personality disorder were analyzed using the Psychodynamic Interventions List (verbal techniques, observer-rated transcripts), and the Session Questionnaire for General and Differential Individual Psychotherapy (common factors, patient-rated after each session). Multilevel modeling was applied.A greater use of supportive techniques was related to a higher therapeutic alliance (b = .28, 95% CI: .01–.55, p = .042). Neither the positive association between interpretative techniques and insight nor the moderating effect of baseline symptom severity could be confirmed. Exploratory analyses revealed associations between problem-solving and different verbal techniques.Therapists’ use of supportive techniques seems to influence the therapeutic alliance positively in patients with personality disorders. The effect of interpretative techniques might depend on other factors like patient characteristics. In general, there seem to be differential and specific associations between different therapists’ verbal techniques and common factors. [ABSTRACT FROM AUTHOR]

Abstract Background Chronic heart failure patients typically suffer from tremendous strain and are managed mainly in primary care. New care concepts adapted to the severity of heart failure are a challenge and need to consider health-related quality of life aspects. This is the first psychometric validation of the German EQ-5D-5L™ as a generic instrument for assessing health-related quality of life (HRQOL) in a primary care heart failure patient sample. Methods Confirmatory factor analysis (CFA) was performed on the baseline EQ-5D-5L™ data from the RECODE-HF study (responses to all items from n = 3225 of 3778 patients). Basic CFA models for HRQOL were calculated based on the EQ-5D-5L™ items using the maximum likelihood (ML) and the asymptotic distribution-free method. In an extended CFA, physical activity and depression were added. The basic CFA ML model was verified for the reduced number of cases of the extended CFA model (n = 3064). In analyses of variance the association of the EQ-5D-5L™ visual analogue scale (VAS) and both the German and the British EQ-5D-5L™ crosswalk index with the SF-36 measure of general health were examined. The discriminant validity was analysed using Pearson’s chi-squared tests applying the New York Heart Association classification, for the VAS and indices analyses of variance were calculated. Results In the basic CFA models the root mean square error of approximation was 0.095 with the ML method, and 0.081 with the asymptotic distribution-free method (Comparative Fit Index > 0.90 for both). Physical activity and depression were confirmed as influential factors in the extended model. The VAS and indices were strongly associated with the SF-36 measure of general health (partial eta-squared 0.525/0.454/0.481; all p