Exploring the Relationship between Adherence to Therapy, Treatment Acceptability, and Clinical Outcomes in Adults with Attention-Deficit/Hyperactivity Disorder: Results from the COMPAS Multicenter Randomized Controlled Trial.

INTRODUCTION: Cognitive behavioral therapy and dialectical behavior therapy (DBT) can be effective in treating adults with ADHD, and patients generally consider these interventions useful. While adherence, as measured by attendance at sessions, is mostly sufficient, adherence to therapy skills has not been assessed. Furthermore, the relationship between patient evaluation of therapy effectiveness, treatment adherence, and clinical outcomes is understudied. OBJECTIVE: This study aimed to examine treatment acceptability and adherence in relation to treatment outcomes in a large randomized controlled trial comparing a DBT-based intervention with a nonspecific active comparison, combined with methylphenidate or placebo. METHOD: A total of 433 adult patients with ADHD were randomized. Participants reported how effective they found the therapy, and adherence was measured by attendance at therapy sessions and by self-reports. Descriptive, between-groups, and linear mixed model analyses were conducted. RESULTS: Participants rated psychotherapy as moderately effective, attended 78.40-94.37% of sessions, and used skills regularly. The best-accepted skills were sports and mindfulness. Groups receiving placebo and/or nonspecific clinical management rated their health condition and the medication effectiveness significantly worse than the psychotherapy and methylphenidate groups. Improvements in clinical outcomes were significantly associated with treatment acceptability. Subjective (self-reported) adherence to psychotherapy was significantly associated with improvements in ADHD symptoms, clinical global efficacy and response to treatment. DISCUSSION: These results further support the acceptability of DBT for adult ADHD and suggest the need to address adherence to treatment to maximize clinical improvements. Results may be limited by the retrospective assessment of treatment acceptability and adherence using an ad hoc instrument.

[INTEGRATE-ADHD: Comparison and Integration of Administrative and Epidemiological ADHD Diagnosis Data through Clinical Assessment - Presentation of the Project]. / INTEGRATE-ADHD: Vergleich und Integration administrativer und epidemiologischer ADHS-Diagnosedaten durch klinisches Assessment ­ Vorstellung des Projekts.

As one of the most frequently diagnosed mental disorders in children and adolescents with sometimes serious individual, family and social consequences, attention deficit/hyperactivity disorder (ADHD) is highly relevant to society and health policy. In Germany, data from statutory health insurance companies has reported increasing ADHD diagnosis prevalence rates over years, while epidemiological data has shown constant and recently even decreasing prevalence rates. The clinical validity of diagnoses from either data sources is unknown. In the framework of the consortium project INTEGRATE-ADHD, 5461 parents of children aged 0 to 17 years with a confirmed administrative ADHD diagnosis insured with the third-largest German statutory health insurance provider (DAK-Gesundheit) in at least one quarter of 2020 were surveyed with the questionnaires from the epidemiological German Health Interview and Examination Survey (KiGGS study) and its in-depth module on child mental health (BELLA study) on their child's ADHD diagnosis and symptoms and on other topics, including comorbidity, utilisation of healthcare services, quality of care and satisfaction, psychosocial risk and protective factors and health-related quality of life. In addition, a subsample of 202 children and adolescents with a clinical diagnosis based on the AMWF S3 guideline on ADHD was analysed. An important aim of the project is to use data linkage on person-level to identify possible causes for the often divergent prevalence estimates from epidemiological and administrative data and to integrate and validate the data sources using a guideline-based clinical diagnosis, thereby contributing to a more accurate population-based prevalence estimate of ADHD in children and adolescents and clarifying actual or supposed contradictions between the data sources. The INTEGRATE-ADHD data linkage project combines administrative, epidemiological and clinical ADHD diagnosis data to create a "three-dimensional view" of the ADHD diagnosis. The results will be used to identify fields of action for healthcare policy and self-administration in the German healthcare system and to derive recommendations for the actors and stakeholders in the field of ADHD. The first results will be published in 2024.

[Can SARS-CoV-2 Infection Status in Preschool Children be Predicted by Pandemic-related Attitudes and Concerns of their Parents? Data from the Würzburg Daycare Centre Studies (Wü-KiTa-CoV, 2020-2022)]. / Lässt sich der SARS-CoV-2-Infektionsstatus bei Kindern über pandemiebezogene Einstellungen und Sorgen ihrer Eltern vorhersagen? Daten der Würzburger Kindertagesstätten-Studien (Wü-KiTa-CoV, 2020­2022).

As part of the Würzburg KiTa-CoV study series, SARS-CoV-2 pandemic-related attitudes/concerns of parents of preschool children attending day care centres were surveyed over a 21-month period. We expected associations between these parental attitudes/concerns and their change over the course of the pandemic, on the one hand, and the SARS-CoV-2 infection status of the children, on the other. Parents of children from nine day-care centres who completed a survey on pandemic-related attitudes/concerns in October 2020, July 2021 and July 2022, were included in the analysis. In July 2022, the children's infection status was determined by measuring nucleocapsid protein antibodies (N-AK) and, in the case of N-AK negative, unvaccinated children, the measurement results of spike protein antibodies (S-AK) against SARS-CoV-2 as indicators of previous infection were also taken into account. Changes in parental attitudes/concerns were analysed using trend tests, and their significance in predicting the child's infection status was analysed using multiple binomial regression analyses. Data were available from parents of 159 children (mean age 3.2 years). The overall group of parents showed an increasingly relaxed attitude towards the pandemic over the study period, although the parents' concerns towards a possible infection of their own increased. The infection status of the children could not be predicted from the initial attitudes and concerns of the parents. However, the subgroup of parents with an uninfected child tended to have a higher level of concerns over the course of the pandemic than the parents with an infected child and did not show the same increasing composure towards the pandemic event. The parents' increasing composure is understandable in the context of the reduced virulence of the virus variants prevailing over time, the increasing availability of testing strategies and vaccinations, and the withdrawal of pandemic-related restrictions. In addition, the mildness of most children's infections may have contributed to their parents' sense of security. The seemingly contradictory increase in parental concerns about infection may be related to the strong increase in the incidence due to omicron variant infections in the population since January 2022. It is possible that the higher level of concerns among parents of uninfected children had a protective effect behaviourally.

[Legal, clinical and structural aspects of modern intensive care for children and adolescents with mental disorders]. / Rechtliche, fachliche und strukturelle Aspekte einer modernen akutstationären Versorgung von Kindern und Jugendlichen mit psychischen Störungen.

Recent years have seen a continuous rise in the proportion of emergency contacts across all mental health-related care structures for children and adolescents. Treatment in a protective intensive care unit constitutes an essential element of care and primarily serves the immediate protection of children and adolescents during mental health crises. Protective intensive care is subject to strict legal requirements. Those requirements were amended in 2017 via changes to § 1631b BGB (German Civil Code), leading to a clear separation of the stay in protective intensive care per se and the use of coercive measures. Using the restructuring of the intensive care unit of the Clinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy at the University Hospital Würzburg as an example, the article illustrates the requirements for modern acute care of children and adolescents with mental disorders.Following the modernisation at the university hospital Würzburg we could drastically reduce the duration of stays in the intensive care unit to a mean of 1.5 days across around 500 admissions per year. Consequently, the risk of hospitalism especially for patients with chronic suicidality is practically non-existent anymore. Since 2017, our cooperation with other clinics in the region has made it possible to care for all underage patients requiring treatment in a protective intensive care unit in child and adolescent psychiatric settings. Long-term treatment over many months in a protective intensive care unit no longer occurs in cases of chronic suicidality.

[Experiences of Violence During Inpatient Child and Adolescent Psychiatric Treatment: An Explorative Study with Implications for Child Protection]. / Gewalterfahrungen während stationärer kinder- und jugendpsychiatrischer Behandlung ­ explorative Studie und Implikationen für den Kinderschutz.

Experiences of Violence During Inpatient Child and Adolescent Psychiatric Treatment: An Explorative Study with Implications for Child Protection Abstract. Objective: Educational and medical institutions care for children and adolescents by providing supervision, schooling, education, therapy, and protection. Nevertheless, children in institutional care are exposed to potential danger through maltreatment and abuse. Method: As part of the establishment of the protection concept at the University Hospital for Child and Adolescent Psychiatry in Würzburg, a retrospective patient survey was conducted. The study population consisted of former inpatient clients from 2006 and 2007, who at the time of the catamnesis were of legal age. The survey was conducted by mail. In addition to items on their experiences of violence, the questionnaire included established scales to assess treatment satisfaction and quality of life (FBB-K, WHO-BREF). Results: Of 568 former patients, 87 (15.3 %) provided valid responses (59 female, mean age at the time of the survey: 24.5 years): 35 former patients (40.2 % of the participants) reported experiences of violence during their inpatient treatment (26 victims only, 7 experiences as victims and perpetrators, and 2 perpetrators only). Experiences as victims mainly included emotional violence (34.5 %), but also physical (5.7 %) and sexual violence (10.3 %). Conclusion: We found a significant correlation between experiences of violence, on the one hand, and retrospective treatment satisfaction and current quality of life, on the other hand. The results of the survey underline the importance of establishing protection concepts in clinics and other institutions.

Betrayed by the nervous system: a comparison group study to investigate the 'unsafe world' model of selective mutism.

The study presented in the following verifies some assumptions of the novel 'unsafe world' model of selective mutism (SM). According to this model, SM is a stress reaction to situations erroneously experienced via cognition without awareness as 'unsafe'. It assumes a high sensitivity to unsafety, whereby the nervous system triggers dissociation or freeze mode at relatively low thresholds. We examine whether there is a correlation between SM, sensory-processing sensitivity and dissociation. We compared a sample of 28 children and adolescents with SM (mean age 12.66 years; 18 females) to 33 controls without SM (mean age 12.45 years; 21 females). Both groups were compared using a medical history sheet, the 'Selective Mutism Questionnaire' (SMQ), a 'Checklist for Speaking Behaviour' (CheckS), the 'Highly Sensitive Person Scale' (HSPS), the 'Child Dissociative Checklist' (CDC), the 'Adolescent Dissociative Experience Scale' (A-DES) and the 'Social Phobia and Anxiety Inventory for Children' (SPAIK). Appropriate parametric and non-parametric tests were conducted to examine differences between groups. The results indicate that sensory-processing sensitivity was significantly higher in the group of children and adolescents with SM [X2(1) = 7.224, p = 0.0007; d = 1.092]. Furthermore, dissociative symptoms were more common in children and adolescents with SM than in controls [F(1, 33) = 13.004, p = 0.001; d = 0.986]. The results indicate that sensory-processing sensitivity and dissociation are important factors of SM that may hold important implications for the treatment. TRIAL REGISTRATION: This study is registered with the ClinicalTrials.gov number NCT04233905.

Safety Profile of Methylphenidate Under Long-Term Treatment in Adult ADHD Patients - Results of the COMPAS Study.

INTRODUCTION: The Comparison of Methylphenidate and Psychotherapy in adult ADHD Study (COMPAS) was a prospective, randomized multicenter clinical trial, comparing methylphenidate (MPH) with placebo (PLAC) in combination with cognitive behavioral group psychotherapy (GPT) or individual clinical management (CM) over the period of 1 year. Here, we report results on treatment safety. METHODS: MPH and PLAC were flexibly dosed. Among 433 randomized patients, adverse events (AEs) were documented and analyzed on an "as received" basis during week 0-52. Electrocardiogram data were recorded at baseline and week 24. RESULTS: Comparing 205 patients who received ≥1 dose of MPH with 209 patients who received PLAC, AEs occurring significantly more frequently in the MPH group were decreased appetite (22 vs. 3.8%), dry mouth (15 vs. 4.8%), palpitations (13 vs. 3.3%), gastrointestinal infection (11 vs. 4.8%), agitation (11 vs. 3.3%), restlessness (10 vs. 2.9%), hyperhidrosis, tachycardia, weight decrease (all 6.3 vs. 1.9%), depressive symptom, influenza (both 4.9 vs. 1.0%), and acute tonsillitis (4.4 vs. 0.5%). Syncope occurred significantly more often in the PLAC group (2.4 vs. 0%). Clinically relevant ECG changes occurred very rarely in both groups. Serious AEs were rare and without a significant group difference. The comparison of 206 patients treated with GPT versus 209 patients who received CM revealed no major differences. Serious AE classified as psychiatric occurred in 5 cases in the CM group and in 1 case in the GPT group. CONCLUSION: In this so far longest-running clinical trial, methylphenidate treatment was safe and well-tolerated.

Does helping mothers in multigenerational ADHD also help children in the long run? 2-year follow-up from baseline of the AIMAC randomized controlled multicentre trial.

ADHD often affects multiple generations in a family. Previous studies suggested that children with ADHD benefit less from therapy if parents are also affected, since ADHD symptoms interfere with treatment implementation. This two-group randomised controlled trial examined whether targeting maternal ADHD boosts the efficacy of parent-child training (PCT) for the child's ADHD. Here, we report follow-up results 2 years from baseline. Mothers of 144 mother-child dyads (ADHD according to DSM-IV) were examined for eligibility (T1) and randomised to 12 weeks of intensive multimodal treatment comprising pharmacotherapy and DBT-based cognitive behavioural group psychotherapy (TG, n = 77) or clinical management comprising non-specific counselling (CG, n = 67) for Step 1 (concluded by T2). Subsequently, all dyads participated in 12 weekly PCT sessions for Step 2 (concluded by T3). In Step 3, participants received maintenance treatments for 6 months (concluded by T4). At 24 months after baseline (T5), we performed follow-up assessments. The primary endpoint was child ADHD/ODD score (observer blind rating). Outcomes at T5 were evaluated using ANCOVA. Assessments from 101 children and 95 mothers were available at T5. Adjusted means (m) of ADHD/ODD symptoms (range 0-26) in children did not differ between TG and CG (mean difference = 1.0; 95% CI 1.2-3.1). The maternal advantage of TG over CG on the CAARS-O:L ADHD index (range 0-36) disappeared at T5 (mean difference = 0.2; 95% CI - 2.3 to 2.6). Sensitivity analyses controlling for medication and significant predictors of follow-up participation showed unchanged outcomes. Within-group outcomes remained improved from baseline. At the 24-month follow-up, TG and CG converged. The superiority of intensive treatment regarding maternal symptoms disappeared. In general, cross-generational treatment seems to be effective in the long term. (BMBF grant 01GV0605; registration ISRCTN73911400).

Long-term cardiovascular safety of psychostimulants in children with attention deficit hyperactivity disorder.

Objective: Side effects are a concern during psychostimulant treatment. Unfortunately, many previous studies only investigated short-term effects of psychostimulants in laboratory settings which lack clinical daily routines. Methods: We examined 1042 patient records of patients with attention deficit hyperactivity disorder (ADHD) who were referred to a pediatric-psychiatry practice over 12 years. Data analysis was based on 466 children with ADHD who were newly treated with psychostimulants and who were not in treatment for elevated blood pressure. We analysed blood pressure percentiles, heart rate and BMI percentiles. Results: There was a decrease in systolic and diastolic blood pressure percentiles. Heart rate was not affected. BMI slightly declined in girls. Conclusions: In general psychostimulants were safe. To further elucidate negative effects of psychostimulants, long-term controlled and randomized studies in naturalistic settings are of interest.

Mean Heart Rate and Parameters of Heart Rate Variability in Depressive Children and the Effects of Antidepressant Medication.

Introduction: Researchers have repeatedly discovered an association between depression and autonomic cardiac dysregulation in adults. However, corresponding data concerning minors are still rare. Method: For this exploratory, cross-sectional study, we included N = 43 minors (age range 9-17 years). The subjects were depressive subjects with or without antidepressant medication (N = 23) or healthy control children (HC) (N = 20). We assessed several indices of cardiac functioning using long-term electrocardiogram data (mean heart rate, HR, and several parameters of heart rate variability, HRV). We hypothesized that increased HR and reduced HRV are associated with depressive disorders. Furthermore, we assessed the impact of age, sex, and antidepressant medication on HR and HRV. Results: When sex and age were controlled for, HR was significantly increased in depressive minors compared to HC. However, our preliminary data suggest that this might not be the case in medicated patients, and there were no differences between groups regarding HRV parameters. There was no significant correlation in the whole sample between severity of depression and both HR and HRV. In the subsample of patients with depression, antidepressant medication was associated with lower HR and higher indices of HRV. Conclusion: The data indicate an association between depression and altered autonomic cardiac regulation, which can already manifests in minors.

A multicentre randomized controlled trial on trans-generational attention deficit/hyperactivity disorder (ADHD) in mothers and children (AIMAC): an exploratory analysis of predictors and moderators of treatment outcome.

OBJECTIVE: We examined predictors and moderators of treatment outcome in mothers and children diagnosed with ADHD in a large multicentre RCT. METHOD: In total, 144 mother-child dyads with ADHD were randomly assigned to either a maternal ADHD treatment (group psychotherapy and open methylphenidate medication, TG) or to a control treatment (individual counselling without psycho- or pharmacotherapy, CG). After maternal ADHD treatment, parent-child training (PCT) for all mother-child dyads was added. The final analysis set was based on 123 dyads with completed primary outcome assessments (TG: n = 67, CG: n = 56). The primary outcome was the change in each child's externalizing symptoms. Multiple linear regression analyses were performed. RESULTS: The severity of the child's externalizing problem behaviour in the family at baseline predicted more externalizing symptoms in the child after PCT, independent of maternal treatment. When mothers had a comorbid depression, TG children showed more externalizing symptoms after PCT than CG children of depressive mothers. No differences between the treatment arms were seen in the mothers without comorbid depression. CONCLUSIONS: Severely impaired mothers with ADHD and depressive disorder are likely to need additional disorder-specific treatment for their comorbid psychiatric disorders to effectively transfer the contents of the PCT to the home situation (CCTISRCTN73911400).

Sequential treatment of ADHD in mother and child (AIMAC study): importance of the treatment phases for intervention success in a randomized trial.

BACKGROUND: The efficacy of parent-child training (PCT) regarding child symptoms may be reduced if the mother has attention-deficit/hyperactivity disorder (ADHD). The AIMAC study (ADHD in Mothers and Children) aimed to compensate for the deteriorating effect of parental psychopathology by treating the mother (Step 1) before the beginning of PCT (Step 2). This secondary analysis was particularly concerned with the additional effect of the Step 2 PCT on child symptoms after the Step 1 treatment. METHODS: The analysis included 143 mothers and children (aged 6-12 years) both diagnosed with ADHD. The study design was a two-stage, two-arm parallel group trial (Step 1 treatment group [TG]: intensive treatment of the mother including psychotherapy and pharmacotherapy; Step 1 control group [CG]: supportive counseling only for mother; Step 2 TG and CG: PCT). Single- and multi-group analyses with piecewise linear latent growth curve models were applied to test for the effects of group and phase. Child symptoms (e.g., ADHD symptoms, disruptive behavior) were rated by three informants (blinded clinician, mother, teacher). RESULTS: Children in the TG showed a stronger improvement of their disruptive behavior as rated by mothers than those in the CG during Step 1 (Step 1: TG vs. CG). In the CG, according to reports of the blinded clinician and the mother, the reduction of children's disruptive behavior was stronger during Step 2 than during Step 1 (CG: Step 1 vs. Step 2). In the TG, improvement of child outcome did not differ across treatment steps (TG: Step 1 vs. Step 2). CONCLUSIONS: Intensive treatment of the mother including pharmacotherapy and psychotherapy may have small positive effects on the child's disruptive behavior. PCT may be a valid treatment option for children with ADHD regarding disruptive behavior, even if mothers are not intensively treated beforehand. TRIAL REGISTRATION: ISRCTN registry ISRCTN73911400 . Registered 29 March 2007.

Does the efficacy of parent-child training depend on maternal symptom improvement? Results from a randomized controlled trial on children and mothers both affected by attention-deficit/hyperactivity disorder (ADHD).

Multimodal treatment of children with ADHD often includes parent-child training (PCT). However, due to the high heritability, parents of children with ADHD are frequently also affected by the disorder, which is likely to constitute a significant barrier to successful treatment of the child. This secondary analysis of our randomized controlled multicentre AIMAC trial (ADHD in mothers and children) investigates whether children's outcomes following parent-child training in combination with maternal ADHD treatment depend on maternal symptom improvement. In a first step focusing on treatment of maternal ADHD, 144 mothers of mother-child dyads were randomized to multimodal ADHD treatment (group psychotherapy plus methylphenidate) or clinical management (mainly supportive counselling). After 12 weeks (T2), a 12-week PCT program (T2-T3) for all mother-child dyads was added to treat children's ADHD. Maternal symptomatology (CAARS-O:L; SCL-90-R) and children's externalizing symptoms (ADHD-ODD Scale, SDQ) were repeatedly assessed (T1 = baseline, T2, T3). Effects of changes in maternal symptomatology (T1-T2) on the change in children's symptom scores (T1-T3) were analysed using a general linear model, controlling for baseline scores, study centre, and maternal treatment group. 125 mother-child dyads were analysed. Mothers showed significant improvements in ADHD symptoms and overall psychopathology [CAARS-O:L ADHD index: mean - 3.54, SE 0.74 p < 0.0001; SCL-90-R Global Severity (GS): mean - 11.03, SE 3.90, p = 0.0056]. Although children's externalizing symptoms improved significantly (ADHD-ODD Scale: mean - 4.46, SE 0.58, p < 0.0001), maternal improvement had no effect on children's outcomes after Bonferroni-Holm correction for multiple testing. The findings do not support our hypothesis that children's outcomes following PCT for ADHD depend on maternal symptom improvements.Trial register CCT-ISRCTN73911400.

ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials.

BACKGROUND: The ESCAschool study addresses the treatment of school-age children with attention-deficit/hyperactivity disorder (ADHD) in a large multicentre trial. It aims to investigate three interrelated topics: (i) Clinical guidelines often recommend a stepped care approach, including different treatment strategies for children with mild to moderate and severe ADHD symptoms, respectively. However, this approach has not yet been empirically validated. (ii) Behavioural interventions and neurofeedback have been shown to be effective, but the superiority of combined treatment approaches such as medication plus behaviour therapy or medication plus neurofeedback compared to medication alone remains questionable. (iii) Growing evidence indicates that telephone-assisted self-help interventions are effective in the treatment of ADHD. However, larger randomised controlled trials (RCTs) are lacking. This report presents the ESCAschool trial protocol. In an adaptive treatment design, two RCTs and additional observational treatment arms are considered. METHODS: The target sample size of ESCAschool is 521 children with ADHD. Based on their baseline ADHD symptom severity, the children will be assigned to one of two groups (mild to moderate symptom group and severe symptom group). The adaptive design includes two treatment phases (Step 1 and Step 2). According to clinical guidelines, different treatment protocols will be followed for the two severity groups. In the moderate group, the efficacy of telephone-assisted self-help for parents and teachers will be tested against waitlist control in Step 1 (RCT I). The severe group will receive pharmacotherapy combined with psychoeducation in Step 1. For both groups, treatment response will be determined after Step 1 treatment (no, partial or full response). In severe group children demonstrating partial response to medication, in Step 2, the efficacy of (1) counselling, (2) behaviour therapy and (3) neurofeedback will be tested (RCT II). All other treatment arms in Step 2 (severe group: no or full response; moderate group: no, partial or full response) are observational. DISCUSSION: The ESCAschool trial will provide evidence-based answers to several important questions for clinical practice following a stepped care approach. The adaptive study design will also provide new insights into the effects of additional treatments in children with partial response. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00008973 . Registered 18 December 2015.

Does intensive multimodal treatment for maternal ADHD improve the efficacy of parent training for children with ADHD? A randomized controlled multicenter trial.

BACKGROUND: This is the first randomized controlled multicenter trial to evaluate the effect of two treatments of maternal attention-deficit hyperactivity disorder (ADHD) on response to parent-child training targeting children's external psychopathology. METHODS: Mother-child dyads (n = 144; ADHD according to DSM-IV; children: 73.5% males, mean age 9.4 years) from five specialized university outpatient units in Germany were centrally randomized to multimodal maternal ADHD treatment [group psychotherapy plus open methylphenidate medication; treatment group (TG): n = 77] or to clinical management [supportive counseling without psychotherapy or psychopharmacotherapy; control group (CG): n = 67]. After 12 weeks, the maternal ADHD treatment was supplemented by individual parent-child training for all dyads. The primary outcome was a change in the children's externalizing symptom scores (investigator blinded to the treatment assignment) from baseline to the end of the parent-child training 6 months later. Maintenance therapy continued for another 6 months. An intention-to-treat analysis was performed within a linear regression model, controlling for baseline and center after multiple imputations of missing values. RESULTS: Exactly, 206 dyads were assessed for eligibility, 144 were randomized, and 143 were analyzed (TG: n = 77; CG: n = 66). After 6 months, no significant between-group differences were found in change scores for children's externalizing symptoms (adjusted mean TG-mean CG=1.1, 95% confidence interval -0.5-2.7; p = .1854), although maternal psychopathology improved more in the TG. Children's externalizing symptom scores improved from a mean of 14.8 at baseline to 11.4 (TG) and 10.3 (CG) after 6 months and to 10.8 (TG) and 10.1 (CG) after 1 year. No severe harms related to study treatments were found, but adverse events were more frequent in TG mothers than in CG mothers. CONCLUSIONS: The response in children's externalizing psychopathology did not differ between maternal treatment groups. However, multimodal treatment was associated with more improvement in maternal ADHD. Child and maternal treatment gains were stable (CCT-ISRCTN73911400).

Altered peripheral BDNF mRNA expression and BDNF protein concentrations in blood of children and adolescents with autism spectrum disorder.

Findings from molecular genetic studies and analyses of postmortem and peripheral tissue led to the hypothesis that neurotrophins-as crucial moderators of neuroplasticity-impact on the pathophysiology of autism spectrum disorder (ASD). The study projects aimed to complement former results on the role of brain-derived neurotrophic factor (BDNF), a member of the neurotrophin family with fundamental impact on brain development and function. The purpose of this work was to investigate peripheral BDNF mRNA expression and BDNF protein concentrations in ASD as potential surrogates for the effects observed in the central nervous system. In a BDNF protein quantification study, serum concentrations were analyzed using Enzyme-Linked Immunosorbent Assays in 24 male patients with ASD, all with an IQ > 70 (age 13.9 ± 3.0 years) and 20 age- and gender-matched healthy control subjects (age 14.4 ± 2.1 years; p = 0.522). In a further independent project, a BDNF mRNA expression analysis, mRNA levels from total blood were assessed by quantitative real-time polymerase chain reaction in a sample of 16 male ASD patients (age 10.8 ± 2.2), 15 age- and gender-matched healthy controls (age 12.1 ± 2.2) and 15 patients with attention deficit hyperactivity disorder as a clinical control group (age 11.8 ± 2.2; p = 0.207). In the protein quantification project, significantly decreased BDNF serum concentrations were found in ASD cases compared to healthy control children (t = -2.123, df = 42, p < 0.05). Analysis of covariance (ANCOVA) revealed this result in accordance with significant reductions in BDNF mRNA expression in ASD, observed in the mRNA expression study (F = 3.65; df = 2.43; p < 0.05); neither age nor IQ confounded the result, as indicated by ANCOVA (F = 3.961; df = 2.41; p < 0.05, η (2) = 0.162). Our study projects supported the notion that neurotrophins are involved in the pathophysiology of ASD. Further studies may eventually contribute to the identification of distinct peripheral mRNA expression and protein concentration patterns possibly supporting diagnostic and therapeutic processes.

Risk and protective factors associated with health-related quality of life in children and adolescents with ADHD in Germany - Findings from the consortium project INTEGRATE-ADHD.

Background: The health-related quality of life (HRQoL) of individuals living with Attention-deficit/hyperactivity disorder (ADHD) is known to be impaired. Identifying factors that influence HRQoL can provide important information for the development of prevention and intervention programmes for affected children and adolescents. The aim of the present study was to investigate health care-related and psychosocial risk and protective factors for HRQoL in children and adolescents with an administrative ADHD diagnosis. Methods: In the consortium project INTEGRATE-ADHD, n = 4,809 parents of children and adolescents aged 7 to 17 years participated in an online survey between October 2021 and August 2022 and answered questions regarding HRQoL (KIDSCREEN-27), health care utilisation, and psychosocial risk and protective factors. Multiple linear regression analyses were conducted to assess the association between these factors and the five HRQoL dimensions of the KIDSCREEN-27. Results: Findings indicate that parental psychopathology and parental burden were risk factors for lower HRQoL in children and adolescents with ADHD. Further, a positive association was found between the five HRQoL dimensions and the psychosocial factors family climate and social support, indicating that these are protective factors. Conclusions: The results highlight the importance of prevention and intervention programmes for individuals with ADHD that consider parental mental health and aim to strengthen resources such as the availability of good family climate and social support.

Differences in frequency between administrative and parent-reported ADHD diagnosis data of children and adolescents taking sociodemographic characteristics into account - Results from the consortium project INTEGRATE-ADHD.

Background: In the project INTEGRATE-ADHD, administrative and parent-reported ADHD diagnosis data of children and adolescents were linked at person level for the first time in Germany. This contribution analyses discrepancies between the data sources, considering sociodemographic characteristics. Methods: Parents of 5,461 0- to 17-year-olds insured with the German statutory health insurance company DAK-Gesundheit in 2020, who had a confirmed administrative diagnosis of ADHD (ICD-10 F90.0-9) in at least one quarter (M1Q criterion), were surveyed online about their child's ADHD diagnosis and other health and care-related topics. Using logistic regression, associations between the presence of a parental report of the child's administrative ADHD diagnosis and sociodemographic predictors were analysed. Results: 71.6 % of parents reported their child's administrative diagnosis of ADHD in the survey. The diagnosis was significantly less likely to be reported by parents of girls, younger children, children with a migration background and children from nuclear families with both biological parents. There were no differences with regard to parental education, urbanisation (urban/rural) or density of care. Bivariate findings were confirmed in the multivariable model. Conclusions: Approximately one third of parents do not report their child's administrative diagnosis of ADHD. The likelihood of parental reporting varies according to sociodemographic factors. This should be considered when contextualising the data sources in the future.

When do parents report their child's administrative ADHD diagnosis? A utilisation-based analysis from the consortium project INTEGRATE-ADHD.

Background: This article examines discrepancies in the frequency of diagnoses of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents in Germany using information on health care utilisation from both administrative and parent-reported survey data linked at person level. Methods: 5,461 parents of 0- to 17-year-olds insured with DAK-Gesundheit in 2020 and being registered with a confirmed administrative ADHD diagnosis (ICD-10 F90.0-9) in at least one quarter in 2020 (M1Q criterion) were surveyed online on their child's ADHD diagnosis, utilisation of specialist care and therapeutic service providers. With regard to the presence of a parental report of the child's documented ADHD diagnosis, administrative data and survey data were bi- and multivariately analysed. Results: The response rate was 21.5 %. ADHD diagnoses were given more frequently in the context of paediatric care, but in the multivariable model with the administrative data only the diagnosis made by mental health professionals (OR = 2.78), in the model with the survey data only utilisation of mental health professionals (OR = 2.99) positively predicted the parental diagnostic report. With regard to the utilisation of therapeutic service providers, only the utilisation of occupational therapy was associated with the parental report of the diagnosis in both data sources. Conclusions: Parental non-reporting of a child's administrative ADHD diagnosis in survey studies can be in part be explained by utilisation characteristics.