Universität zu Köln

Doepfner, Manfred, Hautmann, Christopher, Dose, Christina, Banaschewski, Tobias, Becker, Katja ORCID: 0000-0003-4858-5127, Brandeis, Daniel, Holtmann, Martin, Jans, Thomas, Jenkner, Carolin, Millenet, Sabina, Renner, Tobias, Romanos, Marcel ORCID: 0000-0001-7628-8299 and von Wirth, Elena ORCID: 0000-0003-2461-4966 (2017). ESCAschool study: trial protocol of an adaptive treatment approach for school-age children with ADHD including two randomised trials. BMC Psychiatry, 17. LONDON: BMC. ISSN 1471-244X

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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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Doepfner, Manfred UNSPECIFIED UNSPECIFIED UNSPECIFIED Hautmann, Christopher UNSPECIFIED UNSPECIFIED UNSPECIFIED Dose, Christina UNSPECIFIED UNSPECIFIED UNSPECIFIED Banaschewski, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Becker, Katja UNSPECIFIED orcid.org/0000-0003-4858-5127 UNSPECIFIED Brandeis, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Holtmann, Martin UNSPECIFIED UNSPECIFIED UNSPECIFIED Jans, Thomas UNSPECIFIED UNSPECIFIED UNSPECIFIED Jenkner, Carolin UNSPECIFIED UNSPECIFIED UNSPECIFIED Millenet, Sabina UNSPECIFIED UNSPECIFIED UNSPECIFIED Renner, Tobias UNSPECIFIED UNSPECIFIED UNSPECIFIED Romanos, Marcel UNSPECIFIED orcid.org/0000-0001-7628-8299 UNSPECIFIED von Wirth, Elena UNSPECIFIED orcid.org/0000-0003-2461-4966 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-224757
DOI:	10.1186/s12888-017-1433-9
Journal or Publication Title:	BMC Psychiatry
Volume:	17
Date:	2017
Publisher:	BMC
Place of Publication:	LONDON
ISSN:	1471-244X
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ATTENTION-DEFICIT/HYPERACTIVITY DISORDER; DEFICIT HYPERACTIVITY DISORDER; MULTIMODAL TREATMENT; PARENTING INTERVENTIONS; CONTROLLED MULTICENTER; BEHAVIOR; METAANALYSIS; CHILDHOOD; EFFICACY; NEUROFEEDBACK Multiple languages Psychiatry Multiple languages
Refereed:	Yes
URI:	http://kups.ub.uni-koeln.de/id/eprint/22475