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

Abstract

IntroductionTourette 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.Methods and analysisThis 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 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 months post randomisation.The primary outcome is reduction in tic severity as measured on the Yale Global Tic Severity Scale 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 disseminationThe 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 numbers ISRCTN70758207 and NCT03483493; Pre-results.

Impact of receiving recorded mental health recovery narratives on quality of life in people experiencing psychosis, people experiencing other mental health problems and for informal carers: Narrative Experiences Online (NEON) study protocol for three randomised controlled trials

“…1 . As they are expected, they will not be reported to the REC, in keeping with protocols established for other online studies [ 109 ]. All items in this list are specifically identified in the PIS as a possible harm of taking part in the trial so that potential participants can make an informed choice about participation: Feeling disconnected from others Feeling more pessimistic Feeling emotionally burdened Feeling inadequate Experiencing the release of uncomfortable emotions Engaging in harmful behaviours encountered in narratives.…”

“…1. As they are expected, they will not be reported to the REC, in keeping with protocols established for other online studies [109]. All items in this list are specifically identified in the PIS as a possible harm of taking part in the trial so that potential participants can make an informed choice about participation:…”

Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

“…Furthermore, the return rate for this measure was comparable with the other measures, even though the requirement was for parents and teachers to complete it at all timepoints. Additionally, parents and clinicians in our previous workshops identified changes on the SNAP-IV as being the most meaningful outcome [38] Health economics questionnaires, RUSH and RUSE, were adapted from the CSRI [35] specifically for this study, to enhance the relevance of the questions to ADHD. The measures were co-designed by an expert in health economics (MJ), experts in ADHD (MG, KS, CH) and PPI representatives.…”

Tourette syndrome research highlights from 2019

“…A first pilot study on 23 patients has shown encouraging results in a rater-blind parallel group trial (including a 12 month follow up) 38 . A large (n= +200) UK-based study of ERP using this platform, called ORBIT, will commence shortly 39 .…”