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)

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].