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

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.

Methods 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 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 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 numbers: ISRCTN70758207 and NCT03483493; Pre-results.

Keywords: behaviour therapy; exposure and response prevention; internet; persistent (chronic) motor or vocal tic disorder; tourette’s disorder.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1

Schematic flow diagram of trial design. CAIDS-Q, Child and Adolescent Intellectual Disability Screening Questionnaire; CTU, Clinical Trials Unit; DAWBA, Development and Wellbeing Assessment; YGTSS, Yale Global Tic Severity Scale.

Figure 2

Participant flow chart. Note: The CSRI includes a measure of school attendance. The YGTSS includes both a measure of severity and impairment. C&A-GTS-QOL, Child and adolescent version of the Gilles de la Tourette Syndrome Quality of Life Scale; CAIDS-Q, Child and Adolescent Intellectual Disability Screening Questionnaire; CGAS, Children’s Global Assessment Scale; CGI-I, Clinical Global Impressions-Improvement; CHU9D, Child Health Utility 9D; CSRI, Client Service Receipt Inventory; DAWBA, Development and Wellbeing Assessment; MFQ, Mood and Feelings Questionnaire; PTQ, Parent Tic Questionnaire; PUTS, Premonitory Urge for Tics Scale; RT, research team; SCAS, Spence Child Anxiety Scale; SCQ, Social Communication Questionnaire; SNAP-IV, Swanson, Nolan and Pelham Rating Scale; SDQ, Strengths and Difficulties Questionnaire; YGTSS, Yale Global Tic Severity Scale.