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

Abstract

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.

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

“…ESCApreschool (investigating 3-6-year-old preschool children with ADHD) is one part of the multicentre study ESCAlife, which examines clinical care for children, adolescents and adults with ADHD to optimize evidence-based personalised stepped care approaches across different age groups (see also [37][38][39]).…”

“…ESCApreschool is part of a multicentre consortium studying stepped care approaches for the treatment of ADHD along the lifespan (ESCAlife: Evidence-Based Stepped Care of ADHD along the Lifespan, coordinator Tobias Banaschewski). ESCAlife encompasses stepped care designs in different age groups (preschool age, school age, adolescents, adults), each focusing on the different specific needs in the respective life phases, including 6-12-year-old school children (ESCAschool [37]), 12-17-year-old adolescents (ESCAadol [38]) and 16-45year-old adults (ESCAlate [39]). With regard to design and methodology, the single studies overlap to allow for the examination of selected research questions across all age groups.…”

“…Transcranial sonography (TCS) is used to assess biological predictors of treatment response, especially in younger children. This is part of the transversal project ESCAbrain, which assesses biological data in all ESCAlife trials (see also [37][38][39]). Using TCS, the size of the echogenic region of the substantia nigra is assessed.…”

“…Central randomisation with a 1:1 treatment ratio, analogous to the other ESCA trials [37][38][39], is performed by the CTU at the University Medical Centre Freiburg via fax, using block randomisation with variable block length to ensure concealment of randomisation. Randomisation is stratified by centre.…”

Efficacy of web-assisted self-help for parents of children with ADHD (WASH) – a three-arm randomized trial under field/routine care conditions in Germany

“…Additionally, another non-randomized control group of n = 80 children aged 6 to 12 years with an ADHD diagnosis is enlisted from a currently running project, ESCA-school [21]. ESCA-school is part of the research network Evidence-based, Stepped Care of ADHD along the life span (ESCA-life) funded by the German Ministry of Education and Research.…”