Contributions of authors
Victoria Grahame (https://orcid.org/0000-0003-4541-7574) (Chief Investigator) designed the study, was principal applicant for funding, wrote the study protocol, supervised the overall conduct of the study, interpreted study data and co-wrote the final report.
Ashleigh Kernohan (https://orcid.org/0000-0002-5514-3186) (Health Economist) aided with the design of the study, analysed and interpreted the data and co-wrote the final report.
Ehsan Kharati (https://orcid.org/0000-0002-4439-6751) (Statistician) designed the statistical analysis plan, co-wrote the statistical methodology in the study protocol, conducted the main study analysis, interpreted the study results and co-wrote the final report.
Ayesha Mathias (https://orcid.org/0000-0001-7852-6342) (Trial Manager) provided day-to-day management of trial conduct, contributed to the study protocol, performed monitoring to ensure the trial was conducted to Good Clinical Practice requirements, edited and co-wrote the final report.
Chrissie Butcher (https://orcid.org/0000-0002-1696-1506) (Senior Trial Manager) supervised day-to-day management of trial conduct and co-wrote the report.
Linda Dixon (https://orcid.org/0000-0001-9376-8331) (Co-applicant) contributed to design intervention, provided clinical supervision and delivered training to all therapists.
Sue Fletcher-Watson (https://orcid.org/0000-0003-2688-1734) (Co-applicant and research lead) contributed to design, supervised RAs, helped interpret results and co-wrote the final report.
Deborah Garland (https://orcid.org/0000-0002-3708-4186) (Co-applicant) parent representative, led training and delivery of the LAA comparative arm of study.
Magdalena Glod (https://orcid.org/0000-0001-5798-0044) (RA at Newcastle University) contributed to day-to-day running of the trial at Newcastle and reviewed the final report.
Jane Goodwin (https://orcid.org/0000-0002-5633-9148) (RA at Newcastle University) contributed to day-to-day running of the trial at Newcastle and reviewed the final report.
Saoirse Heron (https://orcid.org/0000-0003-3676-3686) (RA at NHS Lothian) contributed to day-to-day running of the trial at Edinburgh and reviewed the final report.
Emma Honey (https://orcid.org/0000-0001-7016-9096) (Previous PI and Co-applicant at CNTW) contributed to day-to-day running of the trial at Newcastle and reviewed the final report.
Ann Le Couteur (https://orcid.org/0000-0001-9991-3608) (Co-applicant at Newcastle University) contributed to the design, contributed to the study protocol, interpreted the results and co-wrote the final report.
Leila Mackie (https://orcid.org/0000-0003-0209-7021) (PI at NHS Lothian) contributed to day-to-day running of the trial at Edinburgh, delivered the intervention and co-wrote the final report.
Emmanuel Ogundimu (https://orcid.org/0000-0001-9252-9275) (Senior Statistician) co-designed the main study analysis, co-wrote the statistical methodology in the final report, interpreted the results and co-wrote the final report.
Helen Probert (https://orcid.org/0009-0001-7364-024X) (RA at Durham University) contributed to day-to-day running of the trial at Durham and reviewed the final report.
Deborah Riby (https://orcid.org/0000-0001-5747-8441) (Research Lead and Co-applicant at Durham University) contributed to the design, supervised RAs and co-wrote the final report.
Priyanka Rob (https://orcid.org/0000-0001-9039-8099) (RA at CNTW and TEWV) contributed to day-to-day running of the trial at Newcastle and Durham and reviewed the final report.
Leanne Rogan (https://orcid.org/0000-0003-2766-140X) (RA at CNTW and TEWV) contributed to day-to-day running of the trial at Newcastle and Durham and reviewed the final report.
Laura Tavernor (https://orcid.org/0000-0002-1397-5128) (PI at CNTW) contributed to day-to-day running of the trial at CNTW and co-wrote the final report.
Luke Vale (https://orcid.org/0000-0001-8574-8429) (Senior Health Economist) contributed to the design, contributed to the study protocol, interpreted the results and co-wrote the final report.
Elspeth Imogen Webb (https://orcid.org/0000-0003-4150-8508) (PI and Co-applicant at TEWV) contributed to day-to-day running of the trial at TEWV, delivered the intervention and co-wrote the final report.
Christopher Weetman (https://orcid.org/0000-0002-6372-0393) (Database Manager) managed the data entered by centres as well as central data processes, enabled data cleaning and edited the final report.
Jacqui Rodgers (https://orcid.org/0000-0002-1759-316X) (Co-applicant, Research Lead and interim CI at Newcastle University) contributed to the design of the study, contributed to the study protocol, supervised the overall conduct of the study, interpreted study data and co-wrote the final report.
Acknowledgements
The URB trial was only possible due to the generous support from a large number of individuals.
The investigators would also like to acknowledge the NIHR clinical research networks who provided NHS research support to the study.
Clinicians and research staff from across the UK contributed to the study at individual sites and we express our gratitude to all staff at sites in the UK for their support of study recruitment and data collection. We would like to thank the following centres:
- CNTW NHS Foundation Trust with thanks to Susan Wilson and Emily Clare.
- Newcastle University with thanks to Professor Helen McConachie, Dr Thomas Chadwick, Deb Jones and Ewan Lomax.
- NHS Lothian with thanks to Professor Anne O’Hare and Zoe Grayson.
- Edinburgh University with thanks to Eamonn Holmes, Rebecca Iversen, Lewis Montgomery and Sue Davidson.
- TEWV NHS Foundation Trust with thanks to Susan Bonner.
- Durham University with thanks to Sarah Thompson.
We would also like to thank the Newcastle Clinical Trials Unit staff, including previous team members – trial manager Faye Wolstenhulme, database manager Ruth Wood, clinical trial administrators Stephanie Currer, Corcyra Burley and Abigail Moore and senior trial managers Jared Thornton and Jenn Walker.
We would like to thank Professor Adetayo Kasim for his role as statistician during the design and initial running of the trial.
We would like to thank Hannah Tait (Assistant Psychologist) for her help in delivering the intervention and organising clinical participants.
We would like to give a special thanks to everyone who delivered the parent groups within the trial.
We would like to acknowledge the valued contribution of The National Autistic Society Training and Consultancy Team for supporting and organising the training of the Learning About Autism parent group leaders, in particular David Scowcroft, Family Seminar and Support Manager for developing the bespoke training materials for the study.
TSC members
We would like to thank the members of the Trial Steering Committee – Professor Patricia Howlin (Chair), Professor Richard Emsley, Professor Helen Mason, Fiona Gaultier, Nicola King and Helen Black.
DMC members
We thank the members of the Data Monitoring Committee for all their valuable guidance – Professor John Jerrim (Chair), Dr Kathy Leadbitter and Dr Ann Ozsivadjian.
Sponsor
We would like to thank Lyndsey Dixon, Bryony Stokes, Ellie Drummond and the whole sponsor team at CNTW.
Finally, but most importantly, we would like to thank all our participants for taking part in the URB trial.
The protocol paper was published in Trials 1 April 2021. The dissemination plan includes preparation of main results and health economics manuscripts to be submitted to high-impact international peer-reviewed publications.
Patient data statement
This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure to protect everyone’s privacy and it is important that there are safeguards to make sure that they are stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.
Data-sharing statement
All data requests should be submitted to the corresponding author for consideration. Access to available anonymised data may be granted following review.
Ethics statement
This trial received ethical approval on 20 August 2018 from the South West – Plymouth and Cornwall Ethics Committee: 18/SW/0173.
Information governance statement
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust is committed to handling all personal information in line with the UK Data Protection Act (2018) and the General Data Protection Regulation (EU GDPR) 2016/679. Under the Data Protection legislation, CNTW is the data controller, and you can find out more about how we handle personal data, including how to exercise your individual rights, and the contact details for our Data Protection Officer are here: www.cntw.nhs.uk/foi/data-protection/.
Disclosure of interests
Full disclosure of interests: Completed ICMJE forms for all authors, including all related interests, are available in the toolkit on the NIHR Journals Library report publication page at https://doi.org/10.3310/WHTU0367.
Primary conflicts of interest: None declared.
Publications
Grahame V, Dixon L, Fletcher-Watson S, Garland D, Glod M, Goodwin J, et al. A clinical and cost-effectiveness trial of a parent group intervention to manage challenging restricted and repetitive behaviours in young children with autism spectrum disorder: study protocol for a randomised controlled trial. Trials 2021;22(1):240.
Grahame V, Kernohan A, Kharati E, Mathias A, Butcher C, Dixon L, et al. Understanding Repetitive Behaviours: A clinical and cost-effectiveness, multi-site randomised controlled trial of a group for parents and carers of young autistic children. Autism 2025;29(8):1998–2015. https://doi.org/10.1177/13623613251333175