Title: Therapist guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents with Tourette syndrome: an internal pilot study and single-blind randomised controlled trial (ORBIT)
Funder: Department of Health and Social Care

Abstract: Design: A single-blind parallel-group randomised controlled superiority trial comparing treatment as usual (TAU) + therapist guided digital behavioural intervention (BiP TIC) to TAU + online education only with therapist support. An initial 9 month internal pilot study with strict ‘stop-go’ progression criteria will determine the acceptability of randomisation, recruitment, adherence to the intervention and retention to follow-up. Randomisation will use randomised-permuted blocks. A process evaluation with clinicians (n=5), therapists (all), parents and young people (n=20) will explore the acceptability of the intervention and perceived barriers and facilitators for uptake, behaviour change and implementation. Setting: NHS CAMHS and community paediatric services. The intervention will be delivered remotely from 2 regional centres in the Midlands/North (Queen’s Medical Centre, Nottingham) and South of England (Great Ormond Street Hospital, London). Population: children and young people (aged 9-17) with TS or CTD. Health Technology Being Assessed: An internet-delivered, therapist-guided, behavioural intervention for tics (BiP TIC) over 10 weeks consisting of 10 interactive online modules including educative texts, films, gamified challenges, and exercises based on HRT and CBIT [7,8]. Parents receive 10 modules to support their child’s treatment. Therapists have frequent but brief remote text-based contact with participants in order to guide them through the programme. Therapists unlock modules and prompt participants who fail to access the programme or complete homework assignments. The comparator is TAU + education with therapist support (without BiP TIC) with at least weekly contact for 10 weeks without focusing on tic management. Measurement of Costs and Outcomes: Our primary hypotheses is that the remote supported digital behavioural intervention will be superior to the active comparator in reducing tics, as measured using the Yale Global Tic Severity Scale (YGTSS) total tic score. Therapeutic improvement will be assessed in terms of tic reduction, but also broader, clinically relevant outcome measures of social function, quality of life, mood and overall health status. Assessors blind to and independent from treatment delivery will conduct all assessments at baseline and 3, 9, and 18 months post-randomisation. The primary outcome (YGTSS) will be assessed remotely at 3 monthly intervals: baseline and 3, 6, 9, 12, 15 and 18 months post-randomisation. Sample Size: The proposed sample size of 220 is adequate to detect a (‘true’) clinically important average difference of 0.5 of a standard deviation between intervention and comparator with 90% power at p<0.05 (2-sided), allowing for 20% dropout. Project timetable/ Recruitment rate: 4 year trial with a recruitment window of 18 months (Months 6 to 24), requiring 12 participants per month (220 in total). Our national recruitment network has capacity to identify 500 eligible participants over 18 months. Months 6 to 15; Internal Pilot, Months 9 to 42; participant follow-up, Months 42 to 48; analysis and dissemination. Expertise in team: designing and conducting trials of digital interventions with BiP platform, behavioural treatment for TS, mental health in children and young people, health economics, statistics, qualitative research and patient and public involvement. Five applicants authored the HTA Report on treatments for Tourette syndrome in children and young people [1].

Lay abstract: Tourette Syndrome (TS) is a disabling condition that affects around 1% of young people in England. It is characterised by persistent ‘tics’, which are uncontrolled, sudden, explosive, physical movements and vocal sounds which can be highly stigmatising, especially for teenagers, and can often lead to bullying, social exclusion, depression and self-harm. TS causes distress, social and psychological problems and reduced quality of life. TS is commonly treated by medication, but this can have unpleasant side effects such as drowsiness and weight gain. Behavioural treatments (talking therapies that target a person’s behaviours and thoughts) have been shown to reduce tics as effectively as medication. One behavioural treatment is Habit Reversal Training (HRT) which involves learning competing or blocking movements to control tics. Research has shown that young people and their families prefer behavioural treatments. However, there are very few specialist therapists trained to deliver them, and only around 20% of young people in England with TS can get access to behavioural treatment. To access the therapy young people and their families often need to travel large distances, which is expensive and time-consuming. The problem of lack of access to behavioural treatments has prompted the development of remotely-delivered (i.e. at a distance) behavioural interventions using technology and the internet. Different ways of providing therapies remotely include: telephone or Skype sessions with specialist therapists (known as ‘telemedicine’); therapist-guided online programmes; and ‘self-guided’ online therapy (without therapist support). However, there are too few specialist therapists to meet the demands for telemedicine and too few clients persist with self-guided online therapy. So we have chosen to test a therapist-guided online programme called BiP TIC. BiP TIC does not require therapists specialised in the treatment of tics but is supported by health professionals more generally trained in talking therapies such as ‘cognitive behaviour therapy’ (CBT). Within the BiP TIC programme parents can also provide support to their children by accessing dedicated pages on the internet. This research aims to make behavioural treatments for tics available to far more young people with the aim of reducing the severity of tics and improving quality of life. We will conduct a randomised controlled trial (RCT) with around 220 children and young people (CYP) aged 9 to 17 with TS. Half the CYP will receive the BiP TIC remote therapy programme for tics and the other half will receive remote online education with therapist support without focusing on management of tics. Participants will be allocated to each group randomly and will have access to the online content for the duration of the trial. Findings will help show if this online remote therapy for tics is effective and should be rolled-out in the NHS. We have a track record of successful clinical trials and have expertise in online interventions, mental health in young people and treatment of TS. We have involved young people with TS and their parents in the development of this research and are collaborating with the national charity Tourettes Action.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH