BMC Psychiatry | |
ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials | |
Study Protocol | |
Carolin Jenkner1  Sabina Millenet2  Tobias Banaschewski2  Daniel Brandeis2  Tobias Renner3  Marcel Romanos4  Thomas Jans4  Katja Becker5  Elena von Wirth6  Christina Dose6  Christopher Hautmann7  Manfred Döpfner7  Martin Holtmann8  | |
[1] Clinical Trials Unit Freiburg, Medical Center – University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany;Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany;Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital Tübingen, Tübingen, Germany;Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of Würzburg, Würzburg, Germany;Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg and University Hospital Marburg, Marburg, Germany;Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Robert-Koch-Str. 10, 50931, Cologne, Germany;Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of Cologne, Robert-Koch-Str. 10, 50931, Cologne, Germany;School for Child and Adolescent Cognitive Behavioural Therapy (AKiP), University Hospital of Cologne, Cologne, Germany;LWL-University Hospital Hamm, Ruhr-University Bochum, Hamm, Germany; | |
关键词: Attention-deficit/hyperactivity disorder; School-age children; Stepped care; Adaptive treatment; Self-help; Pharmacotherapy; Behaviour therapy; Neurofeedback; | |
DOI : 10.1186/s12888-017-1433-9 | |
received in 2017-04-24, accepted in 2017-07-13, 发布年份 2017 | |
来源: Springer | |
【 摘 要 】
BackgroundThe 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.MethodsThe 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.DiscussionThe 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 registrationGerman Clinical Trials Register (DRKS) DRKS00008973. Registered 18 December 2015.
【 授权许可】
CC BY
© The Author(s). 2017
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
RO202311095167145ZK.pdf | 692KB | download |
【 参考文献 】
- [1]
- [2]
- [3]
- [4]
- [5]
- [6]
- [7]
- [8]
- [9]
- [10]
- [11]
- [12]
- [13]
- [14]
- [15]
- [16]
- [17]
- [18]
- [19]
- [20]
- [21]
- [22]
- [23]
- [24]
- [25]
- [26]
- [27]
- [28]
- [29]
- [30]
- [31]
- [32]
- [33]
- [34]
- [35]
- [36]
- [37]
- [38]
- [39]
- [40]
- [41]
- [42]
- [43]
- [44]
- [45]
- [46]
- [47]
- [48]
- [49]
- [50]
- [51]
- [52]
- [53]
- [54]
- [55]
- [56]
- [57]
- [58]
- [59]
- [60]
- [61]
- [62]
- [63]
- [64]
- [65]
- [66]
- [67]
- [68]
- [69]
- [70]
- [71]
- [72]
- [73]
- [74]
- [75]
- [76]
- [77]
- [78]
- [79]