ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials
Abstract 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 diff...
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| Format: | Article |
| Language: | English |
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BMC
2017-07-01
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| Series: | BMC Psychiatry |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12888-017-1433-9 |
| _version_ | 1818507845034835968 |
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| author | Manfred Döpfner Christopher Hautmann Christina Dose Tobias Banaschewski Katja Becker Daniel Brandeis Martin Holtmann Thomas Jans Carolin Jenkner Sabina Millenet Tobias Renner Marcel Romanos Elena von Wirth |
| author_facet | Manfred Döpfner Christopher Hautmann Christina Dose Tobias Banaschewski Katja Becker Daniel Brandeis Martin Holtmann Thomas Jans Carolin Jenkner Sabina Millenet Tobias Renner Marcel Romanos Elena von Wirth |
| author_sort | Manfred Döpfner |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-10T22:23:41Z |
| format | Article |
| id | doaj.art-f9fe2f0485684290a61d27669ac614fd |
| institution | Directory Open Access Journal |
| issn | 1471-244X |
| language | English |
| last_indexed | 2024-12-10T22:23:41Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Psychiatry |
| spelling | doaj.art-f9fe2f0485684290a61d27669ac614fd2022-12-22T01:31:14ZengBMCBMC Psychiatry1471-244X2017-07-0117111410.1186/s12888-017-1433-9ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trialsManfred Döpfner0Christopher Hautmann1Christina Dose2Tobias Banaschewski3Katja Becker4Daniel Brandeis5Martin Holtmann6Thomas Jans7Carolin Jenkner8Sabina Millenet9Tobias Renner10Marcel Romanos11Elena von Wirth12Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of CologneDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of CologneDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of CologneDepartment of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg UniversityDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the Philipps-University Marburg and University Hospital MarburgDepartment of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg UniversityLWL-University Hospital Hamm, Ruhr-University BochumDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of WürzburgClinical Trials Unit Freiburg, Medical Center – University of Freiburg, Faculty of Medicine, University of FreiburgDepartment of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg UniversityDepartment of Child and Adolescent Psychiatry and Psychotherapy, University Hospital TübingenDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Center of Mental Health, University Hospital of WürzburgDepartment of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Medical Faculty of the University of CologneAbstract 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.http://link.springer.com/article/10.1186/s12888-017-1433-9Attention-deficit/hyperactivity disorderSchool-age childrenStepped careAdaptive treatmentSelf-helpPharmacotherapy |
| spellingShingle | Manfred Döpfner Christopher Hautmann Christina Dose Tobias Banaschewski Katja Becker Daniel Brandeis Martin Holtmann Thomas Jans Carolin Jenkner Sabina Millenet Tobias Renner Marcel Romanos Elena von Wirth ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials BMC Psychiatry Attention-deficit/hyperactivity disorder School-age children Stepped care Adaptive treatment Self-help Pharmacotherapy |
| title | ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials |
| title_full | ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials |
| title_fullStr | ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials |
| title_full_unstemmed | ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials |
| title_short | ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials |
| title_sort | escaschool study trial protocol of an adaptive treatment approach for school age children with adhd including two randomised trials |
| topic | Attention-deficit/hyperactivity disorder School-age children Stepped care Adaptive treatment Self-help Pharmacotherapy |
| url | http://link.springer.com/article/10.1186/s12888-017-1433-9 |
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