Introduction Attention-deficit hyperactivity disorder (ADHD) is characterised by symptoms of inattention, hyperactivity and impulsivity. To improve outcomes, the National Institute for Health and Care Excellence ADHD guidelines recommend regular monitoring of symptoms when children commence medication. However, research suggests that routine monitoring rarely happens, and clinicians often rely on subjective information such as reports from parents and teachers to ascertain improvement. These sources can be unreliable and difficult to obtain. The addition of an objective test of attention and activity (QbTest) may improve the objectivity, reliability and speed of clinical decision-making and so reduce the time to identify the optimal medication dose. This study aims to assess the feasibility and acceptability of a QbTest medication management protocol delivered in routine healthcare services for children with ADHD.
Method and analysis This multisite feasibility randomised controlled trial (RCT) will recruit 60 young people (aged 6–17 years old), diagnosed with ADHD, and starting stimulant medication who are seen by Child and Adolescent Mental Health Services or Community Paediatric services. Participants will be randomised into one of two arms. In the experimental arm (QbTest protocol), the participant will complete a QbTest at baseline (prior to medication initiation), and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later). In the control arm, participants will receive treatment as usual, with at least two follow-up consultations. Measures of parent-, teacher- and clinician-rated symptoms and global functioning will be completed at each time point. Health economic measures will be completed. Clinicians will record treatment decision-making. Acceptability and feasibility of the protocol will be assessed alongside outcome measure completion rates. Qualitative interviews will be conducted.
Ethics and dissemination The findings will be used to inform the development of a fully powered RCT. The results will be submitted for publication in peer-reviewed journals. The study has ethical approval.
Trial registration number NCT03368573; Pre-results.
- continous performance test (CPT)
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Contributors MJG is the Chief Investigator and takes final responsibility for study design, conduct and decision to submit for publication. The study design was conceived by MJG, CLH (senior research fellow) and CH (co-investigator). CLH and MJG wrote the protocol with approval from all authors. BG (statistician and co-investigator) designed and wrote the statistical analysis plan. MJ (health economist and co-investigator) advised on the health economic data collection and analysis. SB, KSa, KSe, CH, JLM, JC, HV and NB (co-investigators) provided advice and critical input on the study design. NB (co-investigator) led on patient and public involvement. SB provided additional expertise on qualitative analysis. KSa, KSe, HV, JC, CH provided additional clinical expertise. JLM provided additional expertise on technology in health designs. All authors critically revised the manuscript for its important intellectual content. All authors read and approved the final manuscript.
Funding This paper presents independent research funded by the National Institute for Health Research (NIHR) Research for Patient Benefit (RfPB), grant number PB-PG-1215-20026. CH, SB, and JLM acknowledges the financial support of the NIHR Nottingham Biomedical ResearchCentre and NIHR MindTech MedTech Co-operative.
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. The study sponsor and funders have no role in study design, including collection, management, analysis and interpretation of data; writing of the report and the decision to submit the report for publication.
Competing interests None declared.
Patient consent Obtained.
Ethics approval This protocol (V.1.1) was approved by West of Scotland REC 1 (REC reference 17/WS/0209) on 7 November 2017.
Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.
Correction notice This article has been corrected since it first published. The Open access licence has been changed to a CC BY licence.
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