Feasibility, satisfaction, and goal attainment in routine telemedicine consultation in child and adolescent psychiatry and psychotherapy.

Telehealth services were rapidly adopted during the COVID-19 pandemic, but evidence regarding the effectiveness and feasibility of telehealth services in child and adolescent mental healthcare is sparse. This study aims to investigate feasibility, satisfaction, and goal attainment in video-delivered consultations in routine care child and adolescent psychiatry and psychotherapy. A total of 1046 patients from four university child and adolescent outpatient psychiatric clinics and one university outpatient unit for child and adolescent psychotherapy were screened for study participation. We examined a) the percentage of patients considered eligible for video-delivered consultation, b) clinicians', parents' and patients' satisfaction with video consultation, c) clinicians' ratings of goal attainment in video consultation, and d) factors associated with satisfaction and goal attainment. 59% of the screening sample (n = 621) fulfilled eligibility criteria and were considered eligible for video consultation. A total of 267 patients consented to participate in the study and received a video consultation. Clinicians reported high levels of satisfaction with video consultation and high levels of goal attainment in video consultations, especially for patients scheduled for initial patient assessments. Parents and patients were also highly satisfied with the video consultations, especially if patients had less severe emotional and behavioral problems. The present findings suggest that video consultations are a feasible and well-accepted alternative to in-person consultations in child and adolescent mental health care, especially for children with less severe symptoms and for children in early phases of assessment and treatment. Limitations include the lack of a control group. The study was registered at the German Clinical Trials Registry (DRKS00023525).

Effectiveness of videoconference-delivered psychotherapy for children, adolescents, and their parents: A meta-analysis of randomized controlled trials.

INTRODUCTION: Over the last years, videoconference-delivered psychotherapy (VCP) has found its way into clinical practice. This meta-analysis is the first to evaluate the effectiveness of VCP for children and adolescents with a mental disorder and their parents. METHODS: A systematic literature search was performed to identify randomized controlled trials (RCTs) that compared the effectiveness of VCP for youths with a mental disorder to a control condition. Twelve studies were included. Two reviewers independently extracted data and rated study quality. RESULTS: Effect size estimates for measures of children's symptoms of mental disorders were large for comparison between VCP and waitlist (posttreatment: Hedges's g = -1.26, k = 5) and negligible for comparisons between VCP and in-person treatment (posttreatment: g = 0.00, k = 6; follow-up: g = -0.05, k = 3). Similarly, effect size estimates for measures of children's functional impairments were large for comparison between VCP and waitlist (posttreatment: g = -1.10, k = 3) and negligible for comparisons between VCP and in-person treatment (posttreatment: g = -0.23, k = 3; follow-up: g = 0.04, k = 2). VCP more effectively reduced symptoms in children with an internalizing disorder (g = -0.88, k = 5) compared to externalizing disorders (g = 0.25, k = 2) or tic disorders (g = -0.08, k = 3). DISCUSSION: The results provide preliminary evidence that VCP is an effective treatment for youths with a mental disorder and their parents. VCP was equally effective as in-person treatment in reducing children's symptoms and functional impairments. Limitations include the limited number of RCTs and incomplete reporting of methodological features.

Parent-Child Inpatient Treatment in Child and Adolescent Mental Healthcare: Predictors of Child Outcomes.

Family inpatient units in child and adolescent mental health (CAMH) services engage all admitted family members in the treatment of children's symptoms. Studies demonstrated improvements in child and family functioning following family inpatient treatment, but evidence regarding predictors of treatment outcome is lacking. We analyzed data of families (n = 66) who received a four-week inpatient treatment for families with severe parent-child interaction problems. Hierarchical linear regression analyses revealed that parents who recalled harsher parenting practices of their own fathers reported greater improvements in their children's externalizing and internalizing problems. Greater improvements in externalizing problems were further predicted by lower parental educational level, less adverse impacts of stressful life events, and less internalizing child problems prior to admission. We therefore conclude that family inpatient treatment was particularly effective for children in families with lower parental education and a history of harsh parenting.

Satisfaction with videoconference-delivered CBT provided as part of a blended treatment approach for children and adolescents with mental disorders and their families during the COVID-19 pandemic: A follow-up survey among caregivers and therapists.

INTRODUCTION: Psychotherapy delivered via videoconferencing (teletherapy) was a well-accepted treatment option for children and adolescents during the early phases of the COVID-19 pandemic. Information on the long-term satisfaction with teletherapy in routine clinical practice is missing. METHODS: Caregivers (parents) and psychotherapists of n = 228 patients (4-20 years) treated in a university outpatient clinic completed a follow-up survey on satisfaction with videoconference-delivered cognitive-behavioral treatment (CBT). The follow-up survey (T2) was conducted about 1 year after initial assessment of treatment satisfaction in 2020 (T1). RESULTS: At follow up, therapists reported that 79% of families had received teletherapy as part of a blended treatment approach including in-person and videoconference delivery of CBT. Wilcoxon tests revealed that satisfaction with teletherapy was stable over time. In addition, parent ratings of the impact of teletherapy on treatment satisfaction and the therapeutic relationship did not change over time. Therapists' ratings of the impact of teletherapy on the therapeutic relationship with the caregiver were more negative at T2 compared to T1. Satisfaction with teletherapy was higher for patients with less pandemic-related stress, less externalizing behavior problems, and older age (all r < .35). CONCLUSION: The high level of satisfaction with teletherapy for children and adolescents treated in routine clinical practice reported in 2020 was maintained after social distancing regulations were eased in 2021. Teletherapy provided as part of a blended treatment approach is a well-accepted method of treatment delivery for youths with mental health problems. The study was registered in the German Clinical Trials Register (DRKS00028639).

Familial Factors Associated With Symptom Severity in Children and Adolescents With ADHD: A Meta-Analysis and Supplemental Review.

OBJECTIVE: Both genetic and environmental factors contribute to the development of ADHD, but associations between risk factors and ADHD symptom severity in affected children remain unclear. This systematic review and meta-analysis synthesizes evidence on the association between familial factors and symptom severity in children with ADHD (PROSPERO CRD42020076440). METHOD: PubMed and PsycINFO were searched for eligible studies. RESULTS: Forty-three studies (N = 11,123 participants) were meta-analyzed. Five additional studies (N = 2,643 participants) were considered in the supplemental review. Parenting stress (r = .25), negative parenting practices (r = .19), broken parental partnership (r = .19), critical life events (r = .17), parental psychopathologies (r = .14-.16), socioeconomic status (r = -.10), and single-parent family (r = .10) were significantly associated with ADHD symptom severity. CONCLUSION: These results suggest that psychosocial familial factors show small but significant associations with symptom severity in children with ADHD. Implications are discussed.

The importance of familial risk factors in children with ADHD: direct and indirect effects of family adversity, parental psychopathology and parenting practices on externalizing symptoms.

BACKGROUND: Children experiencing unfavorable family circumstances have an increased risk of developing externalizing symptoms. The present study examines the direct, indirect and total effects of family adversity, parental psychopathology, and positive and negative parenting practices on symptoms of attention-deficit/hyperactivity disorder (ADHD) and oppositional defiant disorder (ODD) in children with ADHD. METHODS: Data from 555 children (M = 8.9 years old, 80.5% boys) who participated in a multicenter study on the treatment of ADHD (ESCAschool) were analyzed using structural equation modeling (SEM). RESULTS: The SEM analyses revealed that (a) family adversity and parental psychopathology are associated with both child ADHD and ODD symptoms while negative parenting practices are only related to child ODD symptoms; (b) family adversity is only indirectly associated with child ADHD and ODD symptoms, via parental psychopathology and negative parenting practices; (c) the detrimental effect of negative parenting practices on child ADHD and ODD symptoms is stronger in girls than in boys (multi-sample SEM); (d) there are no significant associations between positive parenting practices and child ADHD or ODD symptoms. CONCLUSIONS: Family adversity, parental psychopathology, and negative parenting practices should be routinely assessed by clinicians and considered in treatment planning. Trial registration (18th December 2015): German Clinical Trials Register (DRKS) DRKS00008973.

Cognitive-behavioral teletherapy for children and adolescents with mental disorders and their families during the COVID-19 pandemic: a survey on acceptance and satisfaction.

BACKGROUND: The COVID-19 pandemic is challenging for health care systems around the world. Teletherapy (psychotherapy conducted via videoconference) for children and adolescents offers a promising opportunity not only to provide treatment during social distancing restrictions but also to reduce treatment barriers that might prevent families from seeking care independent of the pandemic. Therefore, it is highly important to examine the implementation and especially the acceptance of and satisfaction with teletherapy. METHODS: Therapists of 561 patients and parents of 227 patients (total 643 patients) aged 3-20 years treated at a university outpatient unit rated their experiences with teletherapy. RESULTS: Following the outbreak of COVID-19, 73% of the patients switched from face-to-face treatment to teletherapy. Both therapists and parents were mainly satisfied with teletherapy and did not report negative impacts on treatment satisfaction or the therapeutic relationship. Stress from COVID-19, age, gender, duration of treatment, psychosocial functioning, and psychopathology were associated with satisfaction, but correlations were low. Sixty-six percent of parents and 53% of therapists intended to use teletherapy in the future. CONCLUSIONS: Teletherapy during the COVID-19 pandemic was well accepted by both parents and therapists. Certain patient characteristics were related to satisfaction. Trial registration The study was retrospectively registered in the German Clinical Trials Register (DRKS00028639).

Predicting delinquent behavior in young adults with a childhood diagnosis of ADHD: results from the Cologne Adaptive Multimodal Treatment (CAMT) Study.

The aim of this study was to investigate which factors predict lifetime reports of delinquent behavior in young adults who had received adaptive multimodal treatment of attention-deficit/hyperactivity disorder (ADHD) starting at ages 6-10 years. Participants were reassessed 13-24 years (M = 17.6, SD = 1.8) after they had received individualized ADHD treatment in the Cologne Adaptive Multimodal Treatment Study (CAMT). Their behavior was classified as non-delinquent (n = 34) or delinquent (n = 25) based on self-reports regarding the number of police contacts, offenses, and convictions at follow-up. Childhood variables assessed at post-intervention (e.g., externalizing child behavior problems, intelligence, and parenting behavior) that were significantly associated with group membership were entered as possible predictors of delinquency in a Chi-squared automatic interaction detector (CHAID) analysis. Delinquent behavior during adolescence and adulthood was best predicted by (a) meeting the symptom count diagnostic criteria for conduct disorder (CD) according to parent ratings, in combination with a nonverbal intelligence of IQ ≤ 106 at post-intervention, and (b) delinquent behavior problems (teacher rating) at post-intervention. The predictor variables specified in the CHAID analysis classified 81% of the participants correctly. The results support the hypothesis that a childhood diagnosis of ADHD is only predictive of delinquent behavior if it is accompanied by early conduct behavior problems. Low nonverbal intelligence was found to be an additional risk factor. These findings underline the importance of providing behavioral interventions that focus on externalizing behavior problems to children with ADHD and comorbid conduct problems.

Prediction of Educational Attainment and Occupational Functioning in Young Adults With a Childhood Diagnosis of ADHD: Results from the Cologne Adaptive Multimodal Treatment (CAMT) Study.

OBJECTIVE: This longitudinal study examined early predictors of educational attainment and occupational functioning in adults with a childhood diagnosis of attention-deficit/hyperactivity disorder (ADHD). METHOD: Participants (n = 70) of the Cologne Adaptive Multimodal Treatment (CAMT) Study were diagnosed with ADHD and received adaptive multimodal ADHD treatment during childhood. They were then followed through adolescence into adulthood. RESULTS: Hierarchical regression analysis revealed that poor reading skill and externalizing behaviors in childhood were early predictors of educational and occupational difficulties in adulthood. The use of stimulant medication in childhood predicted lower high school achievement, probably because medication use was confounded by indication. The regression models improved when intelligence scores and/or externalizing behaviors, especially delinquency, assessed in adolescence were considered as additional predictors. CONCLUSION: Children with ADHD, who continue to show reading difficulties and externalizing behavior problems after initial treatment, are at risk for educational and occupational difficulties and may need additional support.

Disentangling symptoms of externalizing disorders in children using multiple measures and informants.

The trait impulsivity theory suggests that a single, highly heritable externalizing liability factor, expressed as temperamental trait impulsivity, represents the core vulnerability for externalizing disorders. The present study sought to test the application of latent factor models derived from this theory to a clinical sample of children. Participants were 474 German children (age 6-12 years, 81% male) with symptoms of attention-deficit/hyperactivity disorder and externalizing behavior problems participating in an ongoing multicenter intervention study. Using confirmatory factor analyses (CFA) and exploratory structural equation modeling (ESEM), we evaluated several factor models of externalizing spectrum disorders (unidimensional; first-order correlated factors; higher-order factor; fully symmetrical bifactor; bifactor S-1 model). Furthermore, we assessed our prevailing factor models for measurement invariance across raters (clinicians, parents, teachers) and assessment modes (interview, questionnaires). While both CFA and ESEM approaches provided valuable insights into the multidimensionality, ESEM solutions were generally superior since they showed a substantially better model fit and less biased factor loadings. Among the models tested, the bifactor S-1 CFA/ESEM models, with a general hyperactivity-impulsivity reference factor, displayed a statistically sound factor structure and allowed for straightforward interpretability. Furthermore, these models showed the same organization of factors and loading patterns, but not equivalent item thresholds across raters and assessment modes, highlighting cross-situational variability in child behavior. Our findings are consistent with the assumption of the trait impulsivity theory that a common trait, presented as hyperactivity-impulsivity symptoms, underlies all externalizing disorders. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Effectiveness of usual-care cognitive-behavioral therapy for adolescents with depressive disorders rated by parents and patients - an observational study.

BACKGROUND: Depressive disorders are common in adolescence and are associated with a wide range of negative long-term outcomes. Highly controlled randomized controlled trials (RCT) provide considerable evidence for the efficacy of cognitive-behavioral therapy (CBT) as a treatment for depression, but studies examining the effectiveness of CBT in clinical settings are very rare . METHODS: In the present observational study, the changes achieved through routine CBT in adolescents with depressive disorders treated in a clinical setting in terms of a university outpatient clinic were analyzed, and compared to a historical control group of adolescents with depressive disorders who had received treatment as usual. At the start and end of treatment (pre- and post-assessment), parent and self-ratings of the German versions of the Youth Self-Report (YSR), the Child Behavior Checklist (CBCL) and rating scales for depressive symptoms (FBB-DES, SBB-DES) were assessed. A total of 331 adolescents aged 11-18 years with complete data were assessed for the main analysis. RESULTS: The analysis yielded small to large pre-post effect sizes (Cohen's d) for the total sample (d = 0.33 to d = 0.82) and large effect sizes for adolescents who were rated in the clinical range on each (sub) scale at the start of treatment (d = 0.85 to d = 1.30). When comparing patients in the clinical range with historical controls, medium to large net effect sizes (d = 0.53 to d = 2.09) emerged for the total scores in self- and parent rating. However, a substantial proportion of the sample remained in the clinical range at the end of treatment. CONCLUSIONS: These findings suggest that CBT is effective for adolescents with depressive disorders when administered under routine care conditions, but the results must be interpreted with caution due to the lack of a direct control condition. TRIAL REGISTRATION: DRKS, DRKS00021518 . Registered 27 April 2020 - Retrospectively registered, http://drks.de.

The co-occurrence of Attention-Deficit/Hyperactivity Disorder and mathematical difficulties: An investigation of the role of basic numerical skills.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) and dyscalculia, also called mathematics disorder, frequently co-occur, yet the etiology of this comorbidity is poorly understood. AIMS: This study investigated whether impairments in the understanding of numbers and magnitudes (basic numerical skills) are a unique risk factor for mathematical difficulties (MD) or a shared risk factor that could help to explain the association between ADHD and MD. METHODS AND PROCEDURES: Basic numerical skills were assessed with eight subtests in children (age 6-10 years, N = 86) with clinically significant ADHD symptoms and/or MD and typically developing children (control group). This double dissociation design allowed to test for main and interaction effects of ADHD and MD using both classical and Bayesian analysis of variance (ANOVA). OUTCOMES AND RESULTS: Children with MD were impaired in transcoding, complex number and magnitude comparison, and arithmetic fact retrieval. They were not impaired in tasks assessing core markers of numeracy, which might be explained by the sample including children with mathematical difficulties instead of a diagnosed dyscalculia. ADHD was not associated with deficits in any of the tasks. The evidence for an additive combination of cognitive profiles was weak. CONCLUSIONS AND IMPLICATIONS: Impairments in basic numerical skills are uniquely associated with MD and do not represent a shared risk factor for ADHD symptoms and MD.

EEG Data Quality: Determinants and Impact in a Multicenter Study of Children, Adolescents, and Adults with Attention-Deficit/Hyperactivity Disorder (ADHD).

Electroencephalography (EEG) represents a widely established method for assessing altered and typically developing brain function. However, systematic studies on EEG data quality, its correlates, and consequences are scarce. To address this research gap, the current study focused on the percentage of artifact-free segments after standard EEG pre-processing as a data quality index. We analyzed participant-related and methodological influences, and validity by replicating landmark EEG effects. Further, effects of data quality on spectral power analyses beyond participant-related characteristics were explored. EEG data from a multicenter ADHD-cohort (age range 6 to 45 years), and a non-ADHD school-age control group were analyzed (ntotal = 305). Resting-state data during eyes open, and eyes closed conditions, and task-related data during a cued Continuous Performance Task (CPT) were collected. After pre-processing, general linear models, and stepwise regression models were fitted to the data. We found that EEG data quality was strongly related to demographic characteristics, but not to methodological factors. We were able to replicate maturational, task, and ADHD effects reported in the EEG literature, establishing a link with EEG-landmark effects. Furthermore, we showed that poor data quality significantly increases spectral power beyond effects of maturation and symptom severity. Taken together, the current results indicate that with a careful design and systematic quality control, informative large-scale multicenter trials characterizing neurophysiological mechanisms in neurodevelopmental disorders across the lifespan are feasible. Nevertheless, results are restricted to the limitations reported. Future work will clarify predictive value.

Children with Attention-Deficit/Hyperactivity Disorder Grown Up: An 18-Year Follow-Up after Multimodal Treatment.

OBJECTIVE: ADHD treatment has positive effects on behavioral symptoms and psychosocial functioning, but studies that follow children treated for ADHD into adulthood are rare. METHOD: This follow-up study assessed symptom severity and functional outcomes of adults (n = 70) who had received individualized ADHD treatment in the Cologne Adaptive Multimodal Treatment (CAMT) Study at ages 6 to 10 years. RESULTS: Despite symptomatic improvement, participants reported poorer educational and occupational outcomes than expected (e.g., currently unemployed: 17%). They had also been in contact with the justice system more often than expected (e.g., lifetime convictions: 33%) and were impaired on health-related outcomes (e.g., substance use problems: 15%). Several social outcomes were favorable (e.g., long-term relationship/married: 63%). CONCLUSION: Compared to the general population or norm samples, CAMT participants had a higher relative risk (RR) of functional impairments, demonstrating the need for continued support for a substantial proportion of the young adults.

Toward a Dimensional Assessment of Externalizing Disorders in Children: Reliability and Validity of a Semi-Structured Parent Interview.

OBJECTIVE: This study assesses the reliability and validity of the DSM-5-based, semi-structured Clinical Parent Interview for Externalizing Disorders in Children and Adolescents (ILF-EXTERNAL). METHOD: Participant data were drawn from the ongoing ESCAschool intervention study. The ILF-EXTERNAL was evaluated in a clinical sample of 474 children and adolescents (aged 6-12 years, 92 females) with symptoms of attention-deficit/hyperactivity disorder (ADHD). To obtain interrater reliability, the one-way random-effects, absolute agreement models of the intraclass correlation (ICC) for single ICC(1,1) and average measurements ICC(1,3) were computed between the interviewers and two independent raters for 45 randomly selected interviews involving ten interviewers. Overall agreement on DSM-5 diagnoses was assessed using Fleiss' kappa. Further analyses evaluated internal consistencies, item-total correlations as well as correlations between symptom severity and the degree of functional impairment. Additionally, parents completed the German version of the Child Behavior Checklist (CBCL) and two DSM-5-based parent questionnaires for the assessment of ADHD symptoms and symptoms of disruptive behavior disorders (FBB-ADHS; FBB-SSV), which were used to evaluate convergent and divergent validity. RESULTS: ICC coefficients demonstrated very good to excellent interrater reliability on the item and scale level of the ILF-EXTERNAL [scale level: ICC(1,1) = 0.83-0.95; ICC(1,3) = 0.94-0.98]. Overall kappa agreement on DSM-5 diagnoses was substantial to almost perfect for most disorders (0.38 ≤ κ ≤ 0.94). With some exceptions, internal consistencies (0.60 ≤ α ≤ 0.86) and item-total correlations (0.21 ≤ r it ≤ 0.71) were generally satisfactory to good. Furthermore, higher symptom severity was associated with a higher degree of functional impairment. The evaluation of convergent validity revealed positive results regarding clinical judgment and parent ratings (FBB-ADHS; FBB-SSV). Correlations between the ILF-EXTERNAL scales and the CBCL Externalizing Problems were moderate to high. Finally, the ILF-EXTERNAL scales were significantly more strongly associated with the CBCL Externalizing Problems than with the Internalizing Problems, indicating divergent validity. CONCLUSION: In clinically referred, school-age children, the ILF-EXTERNAL demonstrates sound psychometric properties. The ILF-EXTERNAL is a promising clinical interview and contributes to high-quality diagnostics of externalizing disorders in children and adolescents.

The Improvement of Individually Defined Problem Behaviors During a Telephone-Assisted Self-Help Intervention for Parents of Pharmacologically Treated Children with ADHD.

Background: This study examined change in individually defined problem behaviors during a telephone-assisted self-help (TASH) intervention for parents of children with attention-deficit/hyperactivity disorder (ADHD). Method: Parents of children with ADHD and functional impairment despite methylphenidate treatment participated in a 12-month TASH intervention (8 self-help booklets plus up to 14 counseling telephone calls). The severity of three individually defined target problems, of ADHD symptoms, and oppositional symptoms were rated at baseline and after 6 and 12 months; parental satisfaction with the intervention was assessed after 12 months. The problems were categorized according to the type of behavior and the disorder to which they were related (ADHD vs. oppositional symptoms). Results: Repeated measures analyses of variance revealed a significant decrease in problem severity during the intervention. The change in problem severity was greater than the change in ADHD and oppositional symptoms. Correlations between problem severity and symptom severity were low to moderate. Correlations between the change in problem severity and parental satisfaction were moderate. Discussion: The decrease in the individual problem severity during TASH is stronger than the decrease in ADHD and oppositional symptoms. Individually defined problems should be attended to in psychotherapy research to avoid underestimating the benefit of interventions by solely considering standardized measures.

Individualised stepwise adaptive treatment for 3-6-year-old preschool children impaired by attention-deficit/hyperactivity disorder (ESCApreschool): study protocol of an adaptive intervention study including two randomised controlled trials within the consortium ESCAlife.

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a psychosocially impairing and cost-intensive mental disorder, with first symptoms occurring in early childhood. It can usually be diagnosed reliably at preschool age. Early detection of children with ADHD symptoms and an early, age-appropriate treatment are needed in order to reduce symptoms, prevent secondary problems and enable a better school start. Despite existing ADHD treatment research and guideline recommendations for the treatment of ADHD in preschool children, there is still a need to optimise individualised treatment strategies in order to improve outcomes. Therefore, the ESCApreschool study (Evidence-Based, Stepped Care of ADHD in Preschool Children aged 3 years and 0 months to 6 years and 11 months of age (3;0 to 6;11 years) addresses the treatment of 3-6-year-old preschool children with elevated ADHD symptoms within a large multicentre trial. The study aims to investigate the efficacy of an individualised stepwise-intensifying treatment programme. METHODS: The target sample size of ESCApreschool is 200 children (boys and girls) aged 3;0 to 6;11 years with an ADHD diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) or a diagnosis of oppositional defiant disorder (ODD) plus additional substantial ADHD symptoms. The first step of the adaptive, stepped care design used in ESCApreschool consists of a telephone-assisted self-help (TASH) intervention for parents. Participants are randomised to either the TASH group or a waiting control group. The treatment in step 2 depends on the outcome of step 1: TASH responders without significant residual ADHD/ODD symptoms receive booster sessions of TASH. Partial or non-responders of step 1 are randomised again to either parent management and preschool teacher training or treatment as usual. DISCUSSION: The ESCApreschool trial aims to improve knowledge about individualised treatment strategies for preschool children with ADHD following an adaptive stepped care approach, and to provide a scientific basis for individualised medicine for preschool children with ADHD in routine clinical care. TRIAL REGISTRATION: The trial was registered at the German Clinical Trials Register (DRKS) as a Current Controlled Trial under DRKS00008971 on 1 October 2015. This manuscript is based on protocol version 3 (14 October 2016).

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.