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 randomised controlled trial

Abstract

Introduction

Tourette syndrome and chronic tic disorder are common, disabling childhood-onset conditions. Guidelines recommend that behavioural therapy should be offered as first-line treatment for children with tics. However, there are very few trained behaviour therapists for tics and many patients cannot access appropriate care. This trial investigates whether an internet-delivered intervention for tics can reduce severity of symptoms.

Method and analysis

This parallel-group, single-blind, randomised controlled superiority trial with an internal pilot will recruit children and young people (aged 9-17 years) with tic disorders. Participants will be randomised to receive 10-weeks of either online, remotely-delivered, therapist-supported exposure response prevention (ERP) behavioural therapy for tics, or online, remotely delivered, therapist-supported education about tics and co-occurring conditions. Participants will be followed-up mid-treatment, and 3-, 6-, 12-, and 18-month post-randomisation.

The primary outcome is reduction in tic severity as measured on the Yale Global Tic Severity
Scale (YGTSS) total tic severity score. Secondary outcomes include a cost-effectiveness analysis and estimate of the longer-term impact on patient outcomes and healthcare services.
An integrated process evaluation will analyse quantitative and qualitative data in order to fully explore the implementation of the intervention and identify barriers and facilitators to implementation.

The trial is funded by the National Institute of Health Research (NIHR),Health Technology Assessment (16/19/02).
Ethics and dissemination

The findings from the study will inform clinicians, healthcare providers and policy makers about the clinical and cost-effectiveness of an internet delivered treatment for children and young people with tics. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval from North West Greater Manchester Research Ethics Committee (Ref: 18/NW/0079).

Trial registration: ISRCTN70758207 and ClinicalTrials.gov (NCT03483493).

Citation

Hall, C. L., Davies, E. B., Andrén, P., Murphy, T., Bennett, S., Brown, B. J., …Hollis, C. (2019). 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 randomised controlled trial. BMJ Open, 9(1), Article e027583. https://doi.org/10.1136/bmjopen-2018-027583

• Journal Article Type: Article
• Acceptance Date: Nov 14, 2018
• Online Publication Date: Jan 3, 2019
• Publication Date: Jan 3, 2019
• Deposit Date: Nov 27, 2018
• Publicly Available Date: Jan 7, 2019
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 9
• Issue: 1
• Article Number: e027583
• DOI: https://doi.org/10.1136/bmjopen-2018-027583
• Public URL: https://nottingham-repository.worktribe.com/output/1311280
• Publisher URL: https://bmjopen.bmj.com/content/9/1/e027583.full