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Pilot Feasibility Stud. 2018 Mar 2;4:61. doi: 10.1186/s40814-018-0250-3. eCollection 2018.

Protocol for the STAR (Sheffield Treatments for ADHD) project: an internal pilot study assessing the feasibility of the Trials within Cohorts (TwiCs) design to test the effectiveness of interventions for children with ADHD.

Author information

1
1School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA UK.
2
2Institute of Mental Health, Jubilee Campus, University of Nottingham, Wollaton Road, Nottingham, NG8 1BB UK.

Abstract

Background:

Attention deficit hyperactivity disorder (ADHD) is a common and growing problem and a leading cause of child referrals to Child and Adult Mental Health Services (CAMHS). It is a drain on resources across nationally funded support agencies and associated with negative outcomes such as early criminality, school disruption and antisocial behaviour. Mainstream interventions (pharmacological and behavioural) demonstrate effectiveness whilst implemented, but are costly, often have unwanted side effects and do not appear to be affecting long-term outcomes.Development of a robust evidence base for the effectiveness of current and novel interventions and their impact over the long term is required. The aim of the Sheffield Treatments for ADHD Research (STAR) project is to facilitate a rigorous evidence base in order to provide information about the comparative (cost) effectiveness and acceptability of multiple interventions to key stakeholders.

Methods:

The Trials within Cohorts (TwiCs) design was used to build a cohort of children with a diagnosis of ADHD and conduct a three-armed pilot trial of the clinical and cost effectiveness of two novel interventions: (a) treatment by nutritional therapists and (b) treatment by homoeopaths, compared to (c) treatment as usual.Participants are recruited to the STAR long-term observational cohort, and their outcomes of interest (ADHD symptoms, health-related quality of life, school disruption, resource use and criminality) are measured every 6 months by carers and (blinded) teachers. Two promising interventions were identified for the first randomised controlled trial embedded in the cohort. A random selection of eligible participants is offered treatments (a) and (b). The outcomes of those offered treatment are compared to those not offered treatment using intention to treat (ITT) analysis.The feasibility of recruiting to the cohort and the trial, delivering the interventions, the effectiveness of the interventions and the appropriateness, sensitivity and collectability of outcomes is trialled.

Discussion:

The results of this trial will provide information on the feasibility of the TwiCs design to facilitate multiple trials of potential interventions for children with ADHD, and the acceptability, clinical and cost effectiveness of two potential interventions for ADHD to ADHD stakeholders including service providers. Future stages of the STAR project will test other treatments informed by the results in stage 1.

Trial registration:

ISRCTN number 17723526. 10.1186/ISRCTN17723526. Date assigned 27/4/15.

KEYWORDS:

ADHD; Feasibility; Homoeopathy; Nutrition; TwiCs

Conflict of interest statement

The study was approved under the University of Sheffield’s Ethics Review Procedure by the School of Health and Related Research (ScHARR) Research Ethics committee (REC) on 30/4/15, application number 003424. The University of Sheffield is the Research Governance Sponsor (University Research Management System (UMRS) number: 143647). The project was classified as a ‘human-interventional study’, under the University’s quality assurance procedure for such studies, requiring it to be risk assessed, and was considered to be low risk. They confirmed that a trial measuring treatment by a homoeopath and a nutritionist did not constitute a Clinical Trial of a Medicinal Product (CTIMP); therefore, Medicines Regulatory Health Authority (MRHA) approval was not required. The study was registered with the ISRCTN Registry (International Standard Randomised Controlled Trials Number 17723526) on 27/4/2015. The study is overseen by an independent Steering Committee of academics, clinicians and patient representatives, who meet every 6 months for the duration of the trial.All data are anonymised. Schools and participants are informed that their data will be anonymised and kept in a secure location.The authors declare that they have no competing interests.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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