Abstract
BackgroundAttention 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.MethodsThe 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.DiscussionThe 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 registrationISRCTN number 17723526. https://doi.org/10.1186/ISRCTN17723526. Date assigned 27/4/15.
Highlights
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)
Up to 25% of children may not respond to stimulant medication [16,17,18] which is associated with adverse events [19] those with concomitant ADHD and autism spectrum conditions (ASCs) [20,21,22]
The Sheffield Treatments for ADHD Research (STAR) project aims to facilitate a rigorous evidence base in order to provide information about the comparative effectiveness and acceptability of multiple interventions to key stakeholders about interventions which might address treatment gaps. This pilot study addresses the research question: Is the Trials within Cohorts (TwiCs) design feasible to assess the effectiveness of treatments for ADHD? For the study, two interventions with preliminary indications of effectiveness, considered complementary and alternative medicine (CAM) [30], have been selected
Summary
Recruitment At least 140 children aged 5–18 with a diagnosis of ADHD and any accompanying co-morbidities are recruited to an observational cohort and their consent to participate in the cohort is sought by completion of a questionnaire with embedded consent to be contacted again. CQs and TQs are sent out every 6 months to all cohort participants Those refusing the offer of treatment are still asked to complete outcome measures as usual every 6 months and considered members of the offer group. Therapists ask participants and/ or their carer (dependent on age) to complete Measure Your Own Medical Outcome Profile (MYMOP) [54]. The percentage of participants refusing treatment will be considered to determine acceptable levels of refusal since too many refusers may lead to high chance of a type II error and inadequate information to estimate critical parameters for a full trial with reasonable precision. It will be used to ensure that a difference can be seen from the interventions to proceed to the full trial, to inform sample size calculation, and to pilot test the statistical analyses selected. The clinical effect of treatment will be explored by calculating standardised mean differences [57] for those offered and taking up the offer of each treatment to obtain sample size estimates
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
