[Ethical Considerations of Including Minors in Clinical Trials Using the Example of the Indicated Prevention of Psychotic Disorders]. / Minderjährige in klinischen Prüfungen: Ethische Abwägungen ihres Einbezugs am Beispiel der indizierten Prävention psychotischer Erkrankungen.

Ethical Considerations of Including Minors in Clinical Trials Using the Example of the Indicated Prevention of Psychotic Disorders Abstract: As a vulnerable group, minors require special protection in studies. For this reason, researchers are often reluctant to initiate studies, and ethics committees are reluctant to authorize such studies. This often excludes minors from participating in clinical studies. This exclusion can lead to researchers and clinicians receiving only incomplete data or having to rely on adult-based findings in the treatment of minors. Using the example of the study "Computer-Assisted Risk Evaluation in the Early Detection of Psychotic Disorders" (CARE), which was conducted as an 'other clinical investigation' according to the Medical Device Regulation, we present a line of argumentation for the inclusion of minors which weighs the ethical principles of nonmaleficence (especially regarding possible stigmatization), beneficence, autonomy, and fairness. We show the necessity of including minors based on the development-specific differences in diagnostics and early intervention. Further, we present specific protective measures. This argumentation can also be transferred to other disorders with the onset in childhood and adolescence and thus help to avoid excluding minors from appropriate evidence-based care because of insufficient studies.

What do the teachers want? A targeted needs assessment survey for prospective didactic training of psychiatry medical educators.

Objectives: Physicians and psychologists at psychiatric university hospitals are assigned teaching tasks from the first day of work without necessarily having the prerequisite training in teaching methods. This exploratory survey provides a needs-based analysis for the prospective didactic training of physicians and psychologists at psychiatric hospitals in Germany, Austria and Switzerland. Methods: An online questionnaire was distributed at medical schools via email in German-speaking countries in Europe. All physicians involved in teaching medical students at psychiatry faculties were eligible to participate in the survey. Participants were further requested to recruit eligible participants (snowball sampling). Responses were analyzed descriptively, and differences between groups were calculated using nonparametric Mann-Whitney U tests (p<.05). Results: Overall, 97 respondents (male=55, female=42; mean age= 40.6) from 19 medical schools completed the survey. The respondents consisted of 43 residents, 39 specialists, 6 chief physicians and 9 psychologists. Of the respondents, 97.6% rated didactic competence as either highly relevant or rather relevant for teaching medical students. The highest overall interest was shown for bedside teaching (mode=4; IQR: 2-4) and error culture (mode=3; IQR: 2-4). Respondents expressed the highest training needs for topics regarding presentation and communication (mode=3; IQR: 2-3). Resident physicians were significantly more interested in bedside teaching (U=362.0, p=0.004) and roleplay (U=425.0; p=0.036) than specialist physicians, who were more interested in examination didactics (U=415.0; p=0.022). Chief physicians displayed significantly deeper interest in group dynamics (U=51; p=0.023) than specialist physicians. In-person training was preferred by a majority of respondents, and 27.4% preferred online/web-based training. Conclusions: The majority of physicians and psychologists at psychiatric university hospitals considered professional development for faculty to be helpful for teaching medical students. Bedside teaching and error culture management were the most desired teaching topics for training medical teachers. Tailored educational interventions are recommended, with target-oriented priorities for different hierarchical levels.

SARS-CoV-2 and Adolescent Psychiatric Emergencies at the Tübingen University Hospital: Analyzing Trends, Diagnoses, and Contributing Factors.

Psychiatric emergencies have increased in recent decades, particularly with the onset of the SARS-CoV-2 pandemic, and far too little is known about the backgrounds of these emergencies. In this study, we investigated the extent to which the number of psychiatric emergencies changed during and in the aftermath of the SARS-CoV-2 pandemic at the Child and Adolescent Psychiatry (CAP) Tübingen. We considered age and psychiatric diagnoses. Additionally, we evaluated the backgrounds of the emergencies. We applied a mixed- (quantitative and qualitative) methods approach to data on emergency presentations at the CAP Tübingen from the pre-SARS-CoV-2 pandemic period (October 2019-January 2020) to Restriction Phase 1 (October 2020-January 2021), Restriction Phase 2 (October 2021-January 2022), and endemic phase (October 2022-January 2023). The total number of emergencies and those with eating disorders and affective disorders increased, while obsessive-compulsive disorders, expansive disorders and anxiety disorders decreased. The patients presenting in the pre-SARS-CoV-2 pandemic period were younger than those in the subsequent periods. We content-coded the reasons behind the emergency presentations. We also identified four areas of stressors and personality characteristics associated with the emergency presentations. In light of the increasing number of psychiatric emergencies, the long-term aim should be to meet the growing demands and create options for prevention.

Tübinger Training for Autism Spectrum Disorders (TüTASS): a structured group intervention on self-perception and social skills of children with autism spectrum disorder (ASD).

In autism spectrum disorders (ASD), social communication and stereotypical behaviour patterns affect all areas of life, and can result in a decrease of its quality. Previous research has shown promising results for the social skills of groups of children with ASD. Furthermore, a pilot study of the Tübingen Group Training for Autism Spectrum Disorders (TüTASS) has demonstrated that mindfulness-based elements achieve additional positive effects. To build on these findings, the TüTASS training was adapted and expanded. Indeed, the TüTASS currently includes 20 90-min appointments starting with the basic skills of emotions, body, and communication, which are then transferred to personal, family, peer, and school spheres. The appointments have a fixed, consistent structure and each includes a body awareness exercise. In this study, we evaluated the TÜTASS with 27 children with ASD. The results showed improvements in pre-post comparison in behaviours associated with autism, as well as in externalising and internalising behaviours as assessed by parent reports, participant self-reports, and independent raters in participating children. Furthermore, the perceived parent burden in relation to their children decreased, whereas the participants' self-rated quality of life increased. Overall, both the participants and their parents rated the TüTASS very positively in rating sheets and in free feedback. If replicated in larger controlled trials, TÜTASS training might be a useful treatment tool for groups of children with ASD.

Multimodal Sensor-Based Identification of Stress and Compulsive Actions in Children with Obsessive-Compulsive Disorder for Telemedical Treatment.

In modern psychotherapy, digital health technology offers advanced and personalized therapy options, increasing availability as well as ecological validity. These aspects have proven to be highly relevant for children and adolescents with obsessive-compulsive disorder (OCD). Exposure and Response Prevention therapy, which is the state-of-the-art treatment for OCD, builds on the reconstruction of everyday life exposure to anxious situations. However, while compulsive behavior pre-dominantly occurs in home environments, exposure situations during therapy are limited to clinical settings. Telemedical treatment allows to shift from this limited exposure reconstruction to exposure situations in real life. In the SSTeP KiZ study (smart sensor technology in telepsychotherapy for children and adolescents with OCD), we combine video therapy with wearable sensors delivering physiological and behavioral measures to objectively determine the stress level of patients. The setup allows to gain information from exposure to stress in a realistic environment both during and outside of therapy sessions. In a first pilot study, we explored the sensitivity of individual sensor modalities to different levels of stress and anxiety. For this, we captured the obsessive-compulsive behavior of five adolescents with an ECG chest belt, inertial sensors capturing hand movements, and an eye tracker. Despite their prototypical nature, our results deliver strong evidence that the examined sensor modalities yield biomarkers allowing for personalized detection and quantification of stress and anxiety. This opens up future possibilities to evaluate the severity of individual compulsive behavior based on multi-variate state classification in real-life situations. Clinical Relevance- Our results demonstrate the potential for efficient personalized psychotherapy by monitoring physiological and behavioral changes with multiple sensor modalities in ecologically valid real-life scenarios.

[Child and Adolescent Psychiatric Emergencies During the Second Wave of the SARS-CoV2-19 Pandemic: Findings from the Tübingen University Hospital]. / Kinder- und jugendpsychiatrische Notfälle während der zweiten Welle der SARS-CoV2-19-Pandemie.

Child and Adolescent Psychiatric Emergencies During the Second Wave of the SARS-CoV2-19 Pandemic: Findings from the Tübingen University Hospital Abstract. Objective: Child and adolescent psychiatric emergencies during the SARS-CoV2-19 pandemic are part of a controversial discussion. This study investigates the volume of such emergencies, the age of the patients, and the diagnoses of eating disorders and obsessive-compulsive disorders (OCD) that occurred at the Child and Adolescent Psychiatric Center (CAP) Tübingen during the second wave of the pandemic compared to the year before. Methods: We evaluated data on all emergencies at CAP Tübingen (telephone calls, outpatients, patient admissions) from 10/2019-01/2020 (first time period) and 10/2020-01/2021 (second wave). Results: The volume of emergencies during the second wave (319 presentations) was 29.7 % higher than during the first time period, and the number of patients (172 presentations) increased by 10.3 %. Compared to the first time period, the number of inpatients was 27.9 % higher, and the emergency admissions increased by 27.8 %. Patients in the second wave were somewhat older, with an average age of 14.8 years (first period: 14.2 years). Eating disorders were more frequent during the second wave, whereas OCD were more frequent in the first time period. Conclusions: Almost 30 % more emergencies were recorded in the second wave of the pandemic, with especially eating disorders increasing. Systematic emergency records should be documented at all German CAPs to enable demand-oriented planning.

A structured group intervention (TüTASS) with focus on self-perception and mindfulness for children with autism spectrum disorder, ASD. A pilot study.

Autism spectrum disorders (ASD) represent a set of long-lasting severe neurodevelopmental conditions and effective therapeutic interventions are needed. Recent research points to the importance of including mindfulness-based elements to improve emotion and body perception in the psychotherapy of patients with ASD. Therefore, we developed a structured group psychotherapy program The Tübinger Training for Autism Spectrum Disorders (Tübinger Training für Autismus-Spektrum-Störungen; TüTASS) which focuses on mindfulness-based training elements. This pilot study accompanying the TüTASS reports the first results on the feasibility of the program with a pre-post comparison of 25 treated children with ASD. The psychometric assessment comprised five standardized questionnaires/ scales evaluating on the basis of parents and patients self-reports the child's social responsiveness, behavior, strengths and difficulties, quality of life, and depressive symptoms before and after training completion. The results indicated that upon training completion, symptoms with respect to emotional and social problems, externalizing behavior, and attentional and schizoid-compulsive behavior substantially declined. In a questionnaire assessing feasibility and quality of the group training, patients and parents found the therapy highly beneficial, especially as to the focus on emotions and body, and strengths and failures. This training program was developed to bridge the gap of lacking mindfulness-based interventions with the aim to optimize the course of ASD, especially with respect to behavioral disturbances and social-emotional problems.