OPTIMA: a feasibility and pilot study
Research type
Research Study
Full title
On-Line Parent Training for the Initial Management of ADHD referrals: A study of the feasibility of patient recruitment and data capture procedures.
IRAS ID
284344
Contact name
Edmund Sonuga-Barke
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Research Summary
Parent training (PT) should be made available to families where children have attention-deficit/hyperactivity disorder (ADHD) - and oppositional defiant disorder (ODD) - type problems, soon after their referral is made, allowing them to start addressing their children’s behavioural difficulties early on (NICE, 2018). However, typically, PT is offered after a full clinical assessment has been made and an ADHD diagnosis was given. The current long waiting lists for children’s services mean that parents can be left without support and guidance for extended periods. To address this problem, we have developed a new way to deliver PT using a digital application – Structured E-Parenting Support (STEPS). STEPS is designed to provide evidence-based advice and support for parents to help them manage their children’s disruptive and oppositional behaviours.
We have been funded by the National Institute of Health Research to evaluate STEPS in a large multi-centre randomised control trial (RCT) comparing STEPS with waiting as usual. However, before we can proceed with this RCT, we need to establish that we can recruit enough new referrals with ADHD- and ODD-type problems and to make sure our study procedures are acceptable and feasible. These are the aims of the current feasibility study.
This will be an observational study involving parents and teachers of children aged 5-11 years, who have been accepted by children’s services, and screened positive for ADHD- and ODD-type problems. They will be recruited from four NHS Trusts: South London and Maudsley NHS Trust, Solent NHS Trust, Sussex Partnership NHS Foundation Trust, Nottingham University Hospitals NHS Trust. Parents will be asked to complete online questionnaires and will be able to download the STEPS app. Teachers will complete one online questionnaire. The study will be recruiting over 16 weeks and each parent is expected to remain in the study for about 4 weeks.Summary of Results
: STEPS (Structured E-Parenting Support) is a new digital parenting intervention delivered via a mobile phone app. It has been designed to offer timely and convenient support for parents of children aged 5-11 years, who have been referred to clinical services with attention-deficit/hyperactivity disorder-type difficulties. The clinical- and cost-effectiveness of STEPS is currently being evaluated in a randomised controlled trial (RCT), as part of the Online Parenting Training for the Initial Management of ADHD referrals (OPTIMA) research programme funded by the National Institute for Health Research. The present observational feasibility study constituted a preparatory phase of OPTIMA focusing on the feasibility of recruitment using a new digital platform called myHealthE https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbQWmkok1D0NAT3S33XJec03gShX1vDsCWWLvTHB7UyjnY9Xi_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YKO7MlIlQcjIshvZrItDtPBZIwWA-2FcLpiYrpNaClPktOXLHGRXDsxrCZ92625NP-2BqnCmbKbtGBlOJSzMhBuKZFPGpVfQ8WDYH2o4-2FtixNRrsXAqIXiavts39z8-2FoJUPennmHfoWvA-2BhZ-2F2ytYIZsrEIDSJlURSSS71IUGsU5UklMw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C8c1679fec8624baa66f308da9cb6672a%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637994604458327009%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=3AQa4OSPJmDrdKUEqJg4fgNSCIUv%2FER%2FEU6meimAb2I%3D&reserved=0 and establishing whether the planned remote study procedures were acceptable and feasible to the participants.
Of 952 new referrals enrolled on myHealthE between April and July 2021, 121 passed the screening and were identified as ‘OPTIMA eligible’. Overall, 107 parents of new referrals were contacted and 48 consented and were asked, in principle, if they would be willing to take part in the OPTIMA RCT. Parents who completed baseline measures were offered access to STEPS. We estimated whether the rate of recruitment would meet the requirements of the RCT in terms of the number of participants needed to be enrolled each month.
The majority of the feasibility study participants identified as White (75%). Their children were predominantly male (65%) and had an average age of 8.4 years. Nineteen participants per month agreed in principle to take part in the RCT (95% CI: 13.5 – 26.1), meeting the rate required to proceed with the OPTIMA RCT. Overall, parents were satisfied or very satisfied with the study procedures. In conclusion, remote recruitment and study procedures for testing a parenting intervention app are feasible and acceptable for parents.
REC name
London - Riverside Research Ethics Committee
REC reference
20/LO/1173
Date of REC Opinion
2 Dec 2020
REC opinion
Further Information Favourable Opinion