From Maltreatment to Psychiatric Disorders in Childhood and Adolescence: The Relevance of Emotional Maltreatment.

Different forms of maltreatment are thought to incur a cumulative and non-specific toll on mental health. However, few large-scale studies draw on psychiatric diagnoses manifesting in early childhood and adolescence to identify sequelae of differential maltreatment exposures, and emotional maltreatment, in particular. Fine-grained multi-source dimensional maltreatment assessments and validated age-appropriate clinical interviews were conducted in a sample of N = 778 3 to 16-year-olds. We aimed to (a) substantiate known patterns of clinical outcomes following maltreatment and (b) analyse relative effects of emotional maltreatment, abuse (physical and sexual), and neglect (physical, supervisory, and moral-legal/educational) using structural equation modeling. Besides confirming known relationships between maltreatment exposures and psychiatric disorders, emotional maltreatment exerted particularly strong effects on internalizing disorders in older youth and externalizing disorders in younger children, accounting for variance over and above abuse and neglect exposures. Our data highlight the toxicity of pathogenic relational experiences from early childhood onwards, urging researchers and practitioners alike to prioritize future work on emotional maltreatment.

Being an Infant in a Pandemic: Influences of the COVID-19 Pandemic on Infants, Toddlers and Their Mothers in a Clinical Population.

The COVID-19 pandemic and the ongoing lockdowns might have had a strong impact on mental health of mothers and their infants/toddlers. For example, families had to deal with health issues and social isolation, which might have affected mental health and parent-child interactions. The aim of this study is to evaluate differences in (1) infantile regulatory disorders, (2) maternal mental health, (3) the impact of maternal mental health on infantile regulatory disorders, and (4) alterations in the mother-child interaction for participants recruited before versus after the onset of the first German lockdown. For this reason, mother-child dyads have been divided into two groups and were compared by analyzing clinical interviews on psychopathology of mother and child (M.I.N.I. & DC:05) and mother-child-interactions (Emotional Availability Scales). Results showed that (1) differences in infantile sleeping disorders emerged (phi = 0.243; p = 0.016) compared to the pre-lockdown group, while (2) the occurrence of maternal panic and anxiety increased in the post-lockdown group (phi = 0.229; p = 0.022). Moreover, there was (3) an association for maternal panic and child's sleep disorder, and (4) specific associations with maternal non-hostility in the mother-child-interaction. In conclusion, the present study highlights the differences of maternal mental health occurrences and infants' regulatory problems, as well as the possible effects of the COVID-19 pandemic for infants. In the pre-lockdown group, maternal non-hostility might have acted as a promotive factor against regulatory disorders, while this mechanism was mitigated in the post-lockdown group.

Past attachment experiences, the potential link of mentalization and the transmission of behavior to the child by mothers with mental health problems: cross-sectional analysis of a clinical sample.

Maternal capacity to mentalize (= reflective functioning, RF), secure attachment and emotionally available parenting has an impact on the child's development. The transmission of mothers' past attachment experiences gained with both her caregivers in her own childhood and the impact on current mother-child interaction is part of the 'transmission gap.' This study explores the transgenerational transmission mechanisms and the potential moderating effect of RF in a clinical sample of 113 mother-child dyads suffering from mental health problems. In a cross-sectional study, the associations between maternal attachment experiences, RF (coded based on Adult Attachment Interviews) and current mother-child interaction (Emotional Availability Scales) were examined with univariate correlation, moderator analyses, and structural equation models. We found relationships between attachment experiences and mother-child interaction, but RF had no moderating effect. Past loving experiences and perceived neglection, particularly with the own father in childhood, were predictors for the present mother-child interaction. There seems to be an intergenerational transmission of attachment experiences to the ongoing generation. Particularly past adverse childhood experiences with the own father seem to explain currently disruptive interactions with the child.Trial registration: DRKS00017008 and DRKS00016353.

Validation study on the child, adult, and parent version of the ARFID module 2.0 for the Eating Disorder Examination.

OBJECTIVE: This study presents a psychometric evaluation of the avoidant/restrictive food intake disorder (ARFID) module 2.0 for the Eating Disorder Examination (EDE), its child (ChEDE), and parent version. Within a pediatric sample seeking treatment for restrictive feeding or eating disorders and non-treatment-seeking controls, the module's interrater reliability, parent-child agreement, and its convergent, divergent, and discriminant validity were examined. METHOD: The child, adult, and/or parent version of the German ARFID module was administered to N = 176 children and adolescents (0-17 years) and their parents, as were the (Ch)EDE, well-established measures on food-avoidance behaviors, food variety, and body esteem, and objective anthropometric measures. RESULTS: Across all versions of the ARFID module, substantial to almost perfect interrater reliability was shown. Parent-child agreement for ARFID diagnosis was substantial. Based on medium-to-large associations between interview-assessed avoidant/restrictive food intake and questionnaire-assessed food-avoidance behaviors, food variety, and objective weight status, the module showed high convergent validity, especially for the child and parent version. Low associations of avoidant/restrictive food intake with weight and shape concern demonstrated divergent validity. Individuals with ARFID differed significantly from those with anorexia nervosa and individually matched controls in a range of clinical characteristics, indicating discriminant validity. DISCUSSION: This comprehensive validation supports the EDE ARFID module to be a valuable measure for the assessment and diagnosis of ARFID in 0-17-year-olds based on self- and parent-report. Validation of the ARFID module against other interview-based measures on ARFID and its evaluation in an adult sample are pending. PUBLIC SIGNIFICANCE: Based on good reliability and validity of the avoidant/restrictive food intake disorder (ARFID) module for the Eating Disorder Examination (EDE) in its child, adult, and parent version, the present study paves the way for the clinical and research use of the interview-based EDE ARFID module for assessing ARFID across childhood and adolescence.

Emotional maltreatment and neglect impact neural activation upon exclusion in early and mid-adolescence: An event-related fMRI study.

Child maltreatment gives rise to atypical patterns of social functioning with peers which might be particularly pronounced in early adolescence when peer influence typically peaks. Yet, few neuroimaging studies in adolescents use peer interaction paradigms to parse neural correlates of distinct maltreatment exposures. This fMRI study examines effects of abuse, neglect, and emotional maltreatment (EM) among 98 youth (n = 58 maltreated; n = 40 matched controls) using an event-related Cyberball paradigm affording assessment of both social exclusion and inclusion across early and mid-adolescence (≤13.5 years, n = 50; >13.5 years, n = 48). Younger adolescents showed increased activation to social exclusion versus inclusion in regions implicated in mentalizing (e.g., superior temporal gyrus). Individual exposure-specific analyses suggested that neglect and EM coincided with less reduction of activation to social exclusion relative to inclusion in the dorsal anterior cingulate cortex/pre-supplementary motor area (dACC/pre-SMA) among younger versus older adolescents. Integrative follow-up analyses showed that EM accounted for this dACC/pre-SMA activation pattern over and above other exposures. Moreover, age-independent results within respective exposure groups revealed that greater magnitude of neglect predicted blunted exclusion-related activity in the parahippocampal gyrus, while EM predicted increased activation to social exclusion in the precuneus/posterior cingulate cortex.

Maternal sensitivity and intrusiveness in early childhood as predictors of children's weight at school age.

BACKGROUND: While previous research indicates that low maternal sensitivity in mother-child interactions puts children at risk of overweight and obesity, maternal intrusiveness has rarely been investigated in association with children's weight. We investigated whether maternal sensitivity and intrusiveness in early childhood predict children's increased body mass index standard deviation scores (BMI-SDS) at school age. BMI-SDS are standardized for age and gender with respect to a reference standard. METHODS: At baseline (t1), we assessed maternal sensitivity and (non-)intrusiveness of 116 mothers with their children (48.3% female) aged 5-47 months (M = 24.00, SD = 11.36) using the emotional availability scales. We obtained anthropometric data for mothers at t1 by measuring height and weight in the laboratory and for children at birth assessed by medical staff. Six years later (t2) we obtained anthropometric data for children in the laboratory or based on parental report. Linear regression analyses were run with child BMI-SDS at t2 as outcome and sensitivity and (non-)intrusiveness as predictors, adjusting for confounders and exploring child age and gender as moderators. RESULTS: Maternal sensitivity only negatively predicted children's BMI-SDS in girls, while maternal intrusiveness predicted higher child BMI-SDS at school age regardless of child gender. The effect of maternal non-intrusiveness remained significant when controlling for confounders. CONCLUSION: Maternal intrusiveness in early childhood seems to represent a risk factor for increased BMI-SDS in children, while lower maternal sensitivity tends to be a risk factor for increased BMI-SDS in girls. This may have implications for prevention or intervention programmes.

[Suicides Among Adolescents in a Major German City]. / Suizide unter Adoleszenten in einer deutschen Großstadt.

Suicides Among Adolescents in a Major German City Abstract. Objective: Adolescent suicide is a major contributor to the overall mortality in this age group. This study examined sex and age differences in suicide methods. Method: The investigation is based on death certificates from the years 1996 to 2019 of the city of Leipzig and includes all suicides in the age group under 25 years. The impact of sex and age on the method and location of suicide was examined using chi square statistics. Moreover, we verified the association between suicides and death by drug overdose through statistical regression. Results: 140 suicides were included in the study. The suicide methods differed between the age groups (χ² = 17,878; p = .022). Individuals under 21 years of age committed suicide almost exclusively by strangulation, jumping from heights, railway suicide, or deliberate intoxication. With the onset of early adulthood, the spectrum of methods expanded. Suicide methods were also different between the sexes (χ² = 35,166; p < .001): Male adolescents preferred highly lethal methods such as strangulation, whereas in female adolescents intoxication was the leading method of suicide, with a predominance of antidepressants. The annual rates of suicide and death by drug overdose were found to correlate (Pearson correlation = 0,571, p = .004). Minors (χ² = 3.125, p = .077) tended to avoid their own residential environment as a place of suicides compared to adults. Conclusion: When assessing the individual suicide risk and weighing safeguarding measures in clinical practice, the differences shown in the choice of methods should be taken into account.

Suicide after reception into prison: A case-control study examining differences in early and late events.

OBJECTIVE: Prisoners constitute a high-risk group for suicide, with suicide rates about 5 to 8 times higher than in the general population. The first weeks of imprisonment are a particularly vulnerable time, but there is limited knowledge about the risk factors for either early or late suicide events. METHODS: Based on a national total sample of prison suicides in Germany between 2005 and 2017, suicides within the first 2 (4 and 8) weeks after reception into prison were matched by age and penalty length with cases that occurred later. Factors that potentially influence the timing of suicide were investigated. RESULTS: The study has shown that 16.7% (31.5%) of all 390 suicides in German prisons occurred within the first two weeks (two months) of imprisonment. Factors that facilitate adaptation to the prison environment (e.g. prior prison experience) were negatively associated with early suicide events. Factors that hindered the adaptation process (e.g. withdrawal from illicit drugs) were observed more frequently in early suicide events than in late ones. These factors are active at different times of imprisonment. CONCLUSION: At reception, particular attention should be paid to the following factors associated with early suicide events: widowed marital status, lack of prison experience, and drug dependency.

[Evaluation of Short-term Psychoanalytic Child Therapy (PaCT) for Young Children with Depressive Disorders: Results from a Pilot Study]. / Evaluation der Psychoanalytischen Kurzzeittherapie (PaKT) für junge Kinder mit depressiven Störungen: Ergebnisse der Pilotstudie.

Depressive disorders in early childhood are associated with high psychosocial impairment and tend to remain stable over time without adequate treatment. Short-term psychoanalytic therapy is a common form of child psychotherapy, yet there is a lack of empirical evaluation of this approach for young children with depressive disorders. Therefore, this secondary evaluation of a study on the treatment of anxiety disorders used an uncontrolled pre-post design in a clinical setting to investigate whether children with depressive comorbidity would evidence significant diagnostic and symptomatic remission after treatment with manualized short-term Psychoanalytic Child Therapy (PaCT). Nineteen children who had an anxiety disorder and a (subclinical) depressive disorder (assessed with the Preschool Age Psychiatric Assessment using DSM-IV criteria) were treated with PaCT. After treatment, 15 of 19 children (78.94 %) were remitted and 15 of 17 children (88.24 %; 2 were lost to follow-up) were free of depressive disorders at the 6-month follow-up. Further analyses revealed significant effects for pre- to post and pre- to follow-up comparisons regarding internalizing symptoms and overall problems using parent- and (nursery-)teacher-ratings. These results suggest that short-term PaCT shows promise as a treatment for childhood depressive disorders.

"Our difficult job is to take a unified view of the patient " (Winnicott) Psychosomatic work in a children's hospital.

We present our work as psychoanalysts in the interdisciplinary psychosomatic unit of a paediatric hospital. As the starting point for our work we use Winnicott's understanding of the psychosomatic dilemma delineated in his paper on psychosomatic illness in its positive and negative aspects. The central hypothesis is that splitting the medical field into many highly specialized fields can be understood as a display of the psychosomatic patients' inner need for splitting and their defence against integration. Based on four case examples from different developmental periods, we demonstrate the interconnectedness of the relational environment, developmental processes, and psychic and biological conditions, and show how early experiences of threat and deprivation can cause the soma-psyche unit to fragment. Drawing on several psychoanalytic psychosomatic schools, we delineate treatment principles of the psychoanalytic contribution to the interdisciplinary work and of the individual psychoanalytic treatment.

The Longitudinal Communication Curriculum at Leipzig University, Medical Faculty - implementation and first experiences.

Purpose: Communication skills are an essential instrument for building a sustainable patient-doctor-relationship for future doctors. They are learnable and teachable. The learning should be facilitated with the help of a longitudinal curriculum, which is planned at Leipzig University. Project: At the Medical Faculty of Leipzig University, the Longitudinal Communication Curriculum is established since 2016/17. Up to now, the curriculum consists of four parts in which students repeatedly practise their communication skills in curricular and extracurricular courses. Several formats help to teach an integrated learning of communication and physical examination skills. Assessment of communication skills is also performed. Curricular implementation is accompanied by concomitant evaluation. Results: Three parts of the curriculum already have taken place. Students report an increase in communication skills. Students rate the units as instructive and helpful. The assessment of communication skills occurs in two clinical practical examinations (OSCEs). Together with summative assessment a formative feedback was implemented. Students judge this practice as highly positive. Discussion: The curriculum is part of undergraduate medical education in Leipzig. It would be beneficial to add another simulated patient encounter, as well as interprofessional units. Student questionnaires will be evaluated and results will help to develop the curriculum. Conclusion: Consolidation of the curriculum accompanied by evaluation and adaption of content can help to assure the quality of the curriculum. Additional professions and study units shall be integrated in the Longitudinal Communication Curriculum in the future.

Efficacy of parent-infant psychotherapy compared to care as usual in children with regulatory disorders in clinical and outpatient settings: study protocol of a randomised controlled trial as part of the SKKIPPI project.

BACKGROUND: The first years of life are a significant period for child development, when children are particularly sensitive and prone to crises. This early phase lays the foundation for healthy growth. Clinical assessment of psychological symptoms in early infancy and adequate treatment are both important in improving the diagnostic outcome and preventing later long-term developmental consequences. The most common psychological problems in the first 3 years of life are regulatory disorders. The aim of this trial is to investigate the efficacy of Parent-Infant Psychotherapy (PIP) for infants and young children (aged 0-36 months, diagnosed with at least one regulatory disorder) and their mothers, compared to care as usual (CAU). METHODS: In this open multicentre randomised controlled trial, 160 mother-infant dyads are randomised to receive PIP or CAU for 6 weeks of intervention in clinical or outpatient (including home treatment) settings. The primary outcome is the maternal sensitivity (sensitivity scale of the Emotional Availability Scales (EAS)) after 6 weeks. Secondary outcomes include assessment of interaction, mental health problems, attachment, development, psychological factors, treatment adherence, health care system utilisation, and costs, after 6 weeks and 12 months. DISCUSSION: This study will evaluate whether a manualised focus-based short-term psychodynamic psychotherapeutic intervention in mother-child dyads improves the care situation for families of children diagnosed with regulatory disorders, and helps prevent long-term psychopathologies. Assessment of the intervention in different settings will support the development of more tailored interventions for affected infants and their mothers. TRIAL REGISTRATION: German Clinical Trial Register, ID: DRKS00017008 . Registered 03/20/2019.

[Assessment of Maltreatment in Childhood and Adolescence]. / Erfassung von Misshandlung im Kindes- und Jugendalter.

Assessment of Maltreatment in Childhood and Adolescence In view of mounting evidence for substantial prognostic relevance of child maltreatment for the future developmental course, assessment of maltreatment in children and adolescents is increasingly gaining attention. At the same time, maltreatment assessment is replete with difficulties, ranging from the definition of maltreatment and establishment of threshold values determining when events meet prognostically relevant criteria, to poor agreement between sources. The aim of this paper is to provide an overview of instruments for assessing maltreatment in children and adolescents. This overview serves as a point of departure to emphasize the importance of various sources for the purpose of assessing maltreatment and to consider the unique role of the child's or young person's perspective. We conclude with preliminary proposals regarding the role of maltreatment assessment in clinical practice.

Trends in suicide rates during the COVID-19 pandemic restrictions in a major German city.

AIMS: It remains unclear whether the coronavirus disease 2019 (COVID-19) pandemic is having an impact on suicide rates (SR). Economic insecurity and mental disorders are risk factors for suicide, which may increase during the pandemic. METHODS: Data on suicide events in a major city in Germany, and the corresponding life years (LY) were provided by the local authorities. For the year 2020, periods without restrictions on freedom of movement and social contact were compared with periods of moderate and severe COVID-19 restrictions. To avoid distortions due to seasonal fluctuations and linear time trends, suicide risk during the COVID-19 pandemic was compared with data from 2010 to 2019 using an interrupted time series analysis. RESULTS: A total of 643 suicides were registered and 6 032 690 LY were spent between 2010 and 2020. Of these, 53 suicides and 450 429 LY accounted for the year 2020.In 2020, SR (suicides per 100 000 LY) were lower in periods with severe COVID-19 restrictions (SR = 7.2, χ2 = 4.033, p = 0.045) compared with periods without restrictions (SR = 16.8). A comparison with previous years showed that this difference was caused by unusually high SR before the imposition of restrictions, while SR during the pandemic were within the trend corridor of previous years (expected suicides = 32.3, observed suicides = 35; IRR = 1.084, p = 0.682). CONCLUSIONS: SR during COVID-19 pandemic are in line with the trend in previous years. Careful monitoring of SR in the further course of the COVID-19 crisis is urgently needed. The findings have regional reference and should not be over-generalised.

Exclusion Expected? Cardiac Slowing Upon Peer Exclusion Links Preschool Parent Representations to School-Age Peer Relationships.

Attachment theory proposes that children's representations of interactions with caregivers guide information-processing about others, bridging interpersonal domains. In a longitudinal study (N = 165), preschoolers (Mage  = 5.19 years) completed the MacArthur Story Stem Battery to assess parent representations. At school-age (Mage  = 8.42 years), children played a virtual ballgame with peers who eventually excluded them to track event-related cardiac slowing, a physiological correlate of rejection, especially when unexpected. At both ages, parents and teachers reported on peer and emotional problems. During exclusion versus inclusion-related events, cardiac slowing was associated with greater positive parent representations and fewer emerging peer problems. Cardiac slowing served as a mediator between positive parent representations and peer problems, supporting a potential psychophysiological mechanism underlying the generalization of attachment-related representations to peer relationships.

Macro- and Micronutrient Intake in Children with Avoidant/Restrictive Food Intake Disorder.

Although case studies in avoidant/restrictive food intake disorder (ARFID) indicate severe nutritional deficiencies in those with a highly limited amount or variety of food intake, systematic analyses on food intake in treatment-seeking children and adolescents with ARFID are lacking. Within this study, n = 20 patients with an interview-based diagnosis of ARFID (0-17 years) were included and compared to n = 20 healthy controls individually matched for age and sex. Children or parents completed three-day food diaries and a food list. Macronutrient, vitamin, and mineral supply was determined based on the percentage of their recommended intake. The results showed a significantly lower total energy and protein intake in ARFID versus controls, with trends for lower fat and carbohydrate intake. ARFID subtypes of limited amount versus variety of food intake significantly differed in macro-, but not micronutrient intake. Those with ARFID met only 20%-30% of the recommended intake for most vitamins and minerals, with significantly lower intake relative to controls for vitamin B1, B2, C, K, zinc, iron, and potassium. Variety of food intake was significantly reduced in ARFID versus controls in all food groups except carbohydrates. This study demonstrated that ARFID goes along with reduced everyday life macro- and micronutrient intake, which may increase the risk for developmental and health problems. Future studies additionally assessing serum nutrient levels in a larger sample may further explore differences in food intake across diverse ARFID presentations.

[LIFE Child Depression - a prospective longitudinal cohort study on the origin of depressive disorders between childhood and early adulthood]. / LIFE Child Psychische Entwicklung/Depression ­ Prospektive longitudinale Kohortenstudie zur Erfassung von Entstehungsbedingungen depressiver Störungen von der Kindheit bis ins junge Erwachsenenalter.

LIFE Child Depression - a prospective longitudinal cohort study on the origin of depressive disorders between childhood and early adulthood LIFE Child Depression is a prospective longitudinal study on the origin and course of depressive symptoms and disorders between child- and adulthood. The aim of the study is to identify patterns of developmental courses of symptoms and disorders and to investigate the interplay of psychosocial, biological and genetic risk and protective factors in the development of depressive disorders. The present paper gives an overview on results of the study. The sample was already assessed three times. A clinical sample was recruited from two local child psychiatric in- and outpatient services in Leipzig, a control sample was recruited from a children's health check program at our medical faculty (LIFE Child Health) and from the local registration office. We found some important context- and parent-associated risk factors for depressive disorders, such as negative life events, low socioeconomic status and depression in mothers (but not in fathers). Moreover, we found some characteristic biological and cognitive-emotional characteristics of children with depressive disorders, such as low stress-related cortisol, low evaluation of own performance, and more negative cognitions in dealing with stressful situations, low self-esteem and a general impairment of emotional processing of human faces. Only some of the risk factors were found to be specific to depression. Instead, most of them can be regarded as general risk factors for psychological disorders in childhood. It is also noteworthy, that some of the risk associations were gender-specific and need to be looked at from a differential point of view. Our study gives important indications for prevention for children at risk for depressive disorders as well as for therapeutic approaches.

[Postpartum mental health problems: healthcare service situation and effectiveness of parent-infant psychotherapy. Presentation of the SKKIPPI project funded by the German Innovationsfonds]. / Postpartale psychische Erkrankungen: Versorgungslage und Wirksamkeit der Eltern-Säugling-Kleinkind-Psychotherapie. Vorstellung des Innovationsfondprojektes SKKIPPI.

After the birth of a child, parents may experience episodes of stress and psychological strain. Some infants show psychological or somatic stress in the form of early regulatory disorders. While the close connection between parental psychological stress, early regulatory disorders, and the development of the parent-child relationship is well documented, current data on effective treatment options are lacking. Previous care services mostly operate on a preventive basis; evidence-based psychotherapeutic services with a special focus on the parent-child relationship are rare.SKKIPPI is a multicenter research project (Berlin, Flensburg, Hamburg, Leipzig) and consists of several study parts with a mixed methods approach: an epidemiological cohort study, two randomized controlled intervention studies (RCTs), and a qualitative study. A population-based cohort study records the occurrence and determinants of psychosocial stress and mental health disorders, as well as the use of health and social services by parents and their children within the first two years of life, using online questionnaires and telephone interviews. The aim of the two RCTs is to evaluate the efficacy of a focused, dyadic parent-infant psychotherapy (Eltern-Säugling-Kleinkind-Psychotherapie, ESKP) compared to routine treatment in inpatient and outpatient settings. The focus of these RCTs is on the improvement of maternal sensitivity and on mother-child attachment, as well as child development and the reduction of mother-child psychopathological symptoms. The qualitative study intends to reconstruct the perspectives of parents on the assistance system and to explore reasons for underuse. The results are expected to help develop preventive as well as therapeutic strategies in the German health system.

Evaluation of a Family-Based Intervention Program for Children of Mentally Ill Parents: Study Protocol for a Randomized Controlled Multicenter Trial.

Background: Children of mentally ill parents have a three to seven times higher risk of developing mental disorders compared to the general population. For this high-risk group, specialized prevention and intervention programs have already been developed. However, there has been insufficient sytematic evaluation to date. Moreover, effectiveness and the cost-effectiveness data of the respective programs until today is very scarce and at the same time constitutes the pre-condition for the program's implementation into regular health care. Methods: The study consists of a two-group randomized controlled multicenter trial conducted at seven study sites throughout Germany and Switzerland. Participants are families with mentally ill parents and their children aged from 3 to 19 years. The intervention comprises 6 to 8 semi-structured sessions over a period of about 6 months. Topics discussed in the intervention include parental mental illness, coping, family relations and social support. Families in the control condition will receive treatment as usual. The children's mental health, assessed using the K-SADS-PL by blinded external raters will constitute the primary efficacy outcome. Further outcomes will be assessed from the parents' as well as from the children's perspectives. Participants are investigated at baseline, 6, 12, and 18 months after baseline assessment. In addition to the assessment of various psychosocial outcomes, a comprehensive health-economic evaluation will be performed. Discussion: This paper describes the evaluation of a family-based intervention program for children of mentally ill parents (CHIMPs) in the regular health care system in Germany and Switzerland. A methodically sophisticated study design has been developed to reflect the complexity of the actual health care situation. This trial will contribute to the regular health care for the high-risk group of children of mentally ill parents. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT02308462; German Clinical Trials Register: DRKS00006806.