This research was funded by the NIHR Heath Technology Assessment (Ref 16/19/02). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. CH, CLH, EBD and CG acknowledge the financial support of the NIHR Nottingham Biomedical Research Centre and NIHR MindTech MedTech Co-operative. We thank additional members who supported the ORBIT team at University College London and University of Nottingham. We would like to thank Tourettes Action for their support of the trial. We would like to thank our PPI members for their help. We thank members of our TSC, chaired by Edmund Sonuga-Barke, and the members of our DMC, chaired by Stephen Scott. We would also like to thank Angela Summerfield for her continued administrative support and help. We acknowledge that all research at Great Ormond Street Hospital NHS Foundation Trust and University College London Great Ormond Street Institute of Child Health is made possible by the NIHR Great Ormond Street Hospital Biomedical Research Centre. This work used services from the eHealth Core Facility at Karolinska Institutet, which is supported by the Strategic Research Area Healthcare Science.
We would also like to thank our patient identification centres, which recruited patients into the ORBIT study: Guys and St Thomas NHS Foundation Trust (Dr Tammy Hedderly), Oxford Health NHS Foundation Trust (Dr Wendy Woodhouse), North East London NHS Foundation Trust (Dr Ana Mendes and Alex Gaskill), Pennine Care NHS Foundation Trust (Prof Prathiba Chitsabesan), Sussex Partnership NHS Foundation Trust (Dr Anne Marie Skarstam), Central Manchester University Hospitals NHS Foundation Trust (Dr Rachel Elvins), Cumbria Partnership NHS Foundation Trust (Dr Barry Chipchase), Leicestershire Partnership NHS Trust (Rebekah Pole), United Lincolnshire Hospitals NHS Trust (Dr Julie Clarke), East Kent Hospitals University NHS Foundation Trust (Dr Femi Ogunbona), Northern Lincolnshire and Goole NHS Foundation Trust [Dr Suresh Nelapatla (Lisa-Jayne Cottam, Caroline Burnett)], Northumberland Tyne and Wear NHS Foundation Trust (Dr Nadine Mushet), Nottingham University Hospitals NHS Trust (Dr Dilip Nathan), Birmingham Women’s and Children’s NHS Foundation Trust (Dr Ashley Liew) and Northamptonshire Healthcare NHS Foundation Trust (Dr Felicity Larson and Liz Sabin).
Contributions of authors
Chris Hollis (https://orcid.org/0000-0003-1083-6744) was the chief investigator and co-conceived and cowrote the study, the trial protocol (with input from all authors), was responsible for study implementation and general project management. Hollis wrote the discussion and the conclusion (see Chapter 8) and is the guarantor.
Charlotte L Hall (https://orcid.org/0000-0002-5412-6165) co-conceived and cowrote the study design, wrote the trial protocol with input from all authors, was responsible for study implementation and general project management. Hall oversaw trial management and contributed to the conception of the mixed-methods process evaluation and developed the interview guides for qualitative analysis. Hall provided supervision for the process evaluation and wrote the introduction chapter (1). Hall wrote all other chapters and sections.
Kareem Khan (https://orcid.org/0000-0003-3836-2827) was responsible for recruitment and follow-ups. Khan contributed to the conception of the mixed-methods process evaluation and developed the interview guides for qualitative analysis. Khan conducted the data collection and initial analysis of both the quantitative and qualitative data. Khan wrote the process evaluation chapter (6) and supported writing of all other chapters and sections.
Marie Le Novere (https://orcid.org/0000-0002-9479-8599) wrote the health economic analysis plan, conducted the economic evaluation and cowrote the economic evaluation chapter (5).
Louise Marston (https://orcid.org/0000-0002-9973-1131) co-conceived and cowrote the study design, designed and wrote the statistical analysis plan, conducted the analysis, and designed the tables and graphs.
Rebecca Jones (https://orcid.org/0000-0001-6924-0924) co-conceived and cowrote the study design, designed and wrote the statistical analysis plan, conducted the analysis, and designed the tables and graphs.
Rachael Hunter (https://orcid.org/0000-0002-7447-8934) co-conceived and cowrote the study design, designed the economic evaluation, wrote the health economic analysis plan, conducted the economic evaluation, cowrote the economic evaluation chapter (5).
Beverley J Brown (https://orcid.org/0000-0002-1026-278X) was responsible for study implementation, general project management, recruitment, and follow-ups.
Charlotte Sanderson (https://orcid.org/0000-0001-6324-3112) was responsible for study implementation, general project management, recruitment, and follow-ups.
Per Andrén (https://orcid.org/0000-0003-1358-0166) co-conceived and cowrote the study design.
Sophie D Bennett (https://orcid.org/0000-0002-1076-7112) was responsible for study implementation and general project management.
Liam R Chamberlain (https://orcid.org/0000-0002-0432-9415) was a trial therapist.
E Bethan Davies (https://orcid.org/0000-0003-3134-0879) was a trial therapist, contributed to the conception of the mixed-methods process evaluation and developed the interview guides for qualitative analysis. Davies provided supervision for the process evaluation and cowrote the intervention development chapter (2).
Amber Evans (https://orcid.org/0000-0003-2232-3495) was a trial therapist.
Natalia Kouzoupi (https://orcid.org/0000-0002-1748-7156) was a trial therapist.
Caitlin McKenzie (https://orcid.org/0000-0001-7832-4388) was responsible for recruitment and follow-ups.
Isobel Heyman (https://orcid.org/0000-0001-7358-9766) co-conceived and cowrote the study design.
Joseph Kilgariff (https://orcid.org/0000-0002-7195-7753) provided therapist supervision.
Cristine Glazebrook (https://orcid.org/0000-0002-7459-9445) co-conceived and cowrote the study design, conceived and wrote the initial process evaluation design in the trial protocol. Glazebrook contributed to the conception of the mixed-methods process evaluation, developed the interview guides for qualitative analysis and provided supervision for the process evaluation.
David Mataix-Cols (https://orcid.org/0000-0002-4545-0924) co-conceived and cowrote the study design.
Eva Serlachius (https://orcid.org/0000-0001-7115-6422) co-conceived and cowrote the study design.
Elizabeth Murray (https://orcid.org/0000-0002-8932-3695) co-conceived and cowrote the study design and was responsible for study implementation and general project management.
Tara Murphy (https://orcid.org/0000-0003-1759-3562) co-conceived and cowrote the study design, was responsible for study implementation and general project management. Murphy provided therapist supervision and cowrote the intervention development chapter (2).
All authors contributed to the interpretation of the data and re-drafts. All authors had full access to all data in the study and had final responsibility for the decision to submit for publication.
Publications
This monograph draws upon several published peer-reviewed papers, including:
Hall CL, Davies EB, Andrén P, Murphy T, Bennett S, Brown BJ, et al. Investigating a therapist-guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents – ‘online remote behavioural intervention for tics’ (ORBIT) trial: protocol of an internal pilot study and single-blind randomised controlled trial. BMJ Open 2019;9(1):e027583.
Hollis C, Hall CL, Jones R, Marston L, Le Novere M, Hunter R, et al. Therapist-supported online remote behavioural intervention for tics in children and adolescents in England (ORBIT): a multicentre, parallel group, single-blind, randomised controlled trial. The Lancet Psychiatry 2021;8(10):871–82.
Hollis C, Hall CL, Khan K, Jones R, Marston L, Le Novere M, et al. Long term clinical and cost-effectiveness of a therapist-supported online remote behavioural intervention for tics (ORBIT) in children and adolescents: extended 12 and 18-month follow-up of a single-blind randomised controlled trial. J Child Psychol Psychiatry 2023;64(6):941–51.
Khan K, Hollis C, Hall CL, Davies EB, Mataix-Cols D, Andrén P, et al. Protocol for the process evaluation of the online remote behavioural intervention for tics (ORBIT) randomized controlled trial for children and young people. Trials 2020;21:1–10.
Khan K, Hollis C, Hall CL, Murray E, Davies EB, Andrén P, et al. Fidelity of delivery and contextual factors influencing children’s level of engagement: process evaluation of the online remote behavioral intervention for tics trial. J Med Internet Res 2021;23(6):e25470.
Khan K, Hollis C, Hall CL, Davies EB, Murray E, Andrén P, et al. Factors influencing the efficacy of an online behavioural intervention for children and young people with tics: process evaluation of a randomised controlled trial. J Behav Cogn Ther 2022;3:197–206.
Khan K. Process Evaluation for Online Remote Behavioural Intervention (ORBIT) Trial. PhD thesis. Nottingham: University of Nottingham; 2021.
Ethics statement
Ethical and Health Research Authority approval was received from Northwest Greater Manchester Research Ethics Committee on 23 March 2018 (ref.: 18/NW/0079) and thus the study was conducted in line with the Declaration of Helsinki.
Data-sharing statement
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, data dictionary and appendices), will be available. All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review and appropriate agreements being in place.
Disclaimers
This report presents independent research funded by the National Institute for Health and Care Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, the HTA programme or the Department of Health and Social Care.