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




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BMC Psychiatry

, 17:269

Child, adolescent and developmental psychiatry

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.

KeywordsAttention-deficit-hyperactivity disorder School-age children Stepped care Adaptive treatment Self-help Pharmacotherapy Behaviour therapy Neurofeedback AbbreviationsBooster Self-HelpStep 2 treatment arm for full responders in the moderate group receiving booster sessions of telephone-assisted self-help for parents and teachers

BTStep 2 treatment arm for partial responders in the moderate group receiving behaviour therapy.

Cont. MED and BTStep 2 treatment arm for partial responders in the severe group receiving continued ADHD medication treatment and behaviour therapy.

Cont. MED and CounsellingStep 2 treatment arm for partial responders and full responders in the severe group receiving continued ADHD medication treatment plus counselling.

Cont. MED and NFStep 2 treatment arm for partial responders in the severe group receiving continued ADHD medication treatment and neurofeedback in Step 2.

MED Management and BTStep 2 treatment arm for non-responders in the moderate group and in the severe group receiving alternative pharmacotherapy plus behaviour therapy in Step 2.

PE and MEDStep 1 treatment arm of the severe group receiving psychoeducation plus ADHD medication treatment.

Step 1First of two treatment periods with a duration of 3 months; for Waiting Control condition of the moderate group, Step 1 takes 6 months, because after the waiting period participants receive the self-help programme.

Step 2Second of two treatment periods with a duration of 6 months.

T0-T1Screening and baseline data assessment.

T2Assessment after of Step 1 and before beginning of Step 2 intervention; for families randomised to Waiting Control in the moderate group, there are two T2 assessments: one after the three-month waiting period and one after the self-help programme.

T3Assessment after Step 2 intervention.

T4Follow-up assessment three months after the end of Step 2 intervention.

TASHStep 1 treatment arm of the moderate group receiving telephone-assisted self-help for parents and teachers.

Waiting ControlStep 1 treatment arm of the moderate group randomised to waitlist control group.

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Autor: Manfred Döpfner - Christopher Hautmann - Christina Dose - Tobias Banaschewski - Katja Becker - Daniel Brandeis - Martin Ho

Fuente: https://link.springer.com/



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