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

Charlotte Lucy Hall; E Bethan Davies; Per Andrén; Tara Murphy; Sophie Bennett; Beverley J Brown; Susan Brown; Liam Chamberlain; Michael P Craven; Amber Evans; Cristine Glazebrook; Isobel Heyman; Rachael Hunter; Rebecca Jones; Joseph Kilgariff; Louise Marston; David Mataix-Cols; Elizabeth Murray; Charlotte Sanderson; Eva Serlachius; Chris Hollis; ORBIT Trial team.

doi:10.1136/bmjopen-2018-027583

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

BMJ Open. 2019 Jan 3;9(1):e027583. doi: 10.1136/bmjopen-2018-027583.

Authors

Charlotte Lucy Hall¹, E Bethan Davies², Per Andrén³, Tara Murphy⁴, Sophie Bennett⁵, Beverley J Brown², Susan Brown², Liam Chamberlain⁶, Michael P Craven², Amber Evans⁷, Cristine Glazebrook⁸, Isobel Heyman⁹, Rachael Hunter¹⁰, Rebecca Jones¹¹, Joseph Kilgariff¹², Louise Marston¹³, David Mataix-Cols¹⁴, Elizabeth Murray¹⁵, Charlotte Sanderson¹⁶, Eva Serlachius¹⁷, Chris Hollis¹⁸; ORBIT Trial team.

Collaborators

ORBIT Trial team.:
Robin Carpenter, Caitlin Hand, Anne Marie Downey, Kareem Khan, Natalia Lago, Jennifer L Martin, Roz Shafran

Affiliations

¹ Trial Manager, Institute of Mental Health, University of Nottingham, Nottingham, UK.
² Research Fellow and Trial Therapist, NIHR MindTech Medtech Co-operative, Institute of Mental Health, University of Nottingham, Nottingham, UK.
³ Clinical Psychologist, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm Health Care Services, Stockholm, Sweden.
⁴ Consultant Psychologist, University College London, Hospital for Children NHS Foundation Trust, London, UK.
⁵ Senior Research Fellow, University College London, Hospital for Children NHS Foundation Trust, London, UK.
⁶ Trial Therapist, Division of Psychiatry and Applied Psychology, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
⁷ Trial Therapist, University College London, Hospital for Children NHS Foundation Trust, Nottingham, UK.
⁸ Professor of Health Psychology, Division of Psychiatry and Applied Psychology, Institute of Mental Health, Nottingham, UK.
⁹ Consultant Psychiatrist, Hospital for Children NHS Foundation Trust, London, UK.
¹⁰ Health Economist, Research Department of Primary care and Population health and Priment CTU, University College London, London, UK.
¹¹ Senior Research Associate, Research Department of Primary care and Population health and Priment CTU, University College London, London, UK.
¹² Advanced Nurse, Division of Psychiatry and Applied Psychology, University of Nottingham, Queen's Medical Centre, Nottingham, UK.
¹³ Principal Research Associate, Research Department of Primary care and Population Health and Priment CTU, University College London, London, UK.
¹⁴ Professor of Child and Adolescent Psychiatric Science, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden and Stockholm Health Care Services, London, UK.
¹⁵ Professor of eHealth and Primary Care, eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, Sweden.
¹⁶ Research Clinical Psychologist, University College London, London, UK.
¹⁷ Assistant Professor in Child and Adolescent Psychiatry, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.
¹⁸ Queens Medical Centre, Professor of Child and Adolescent Psychiatry, Developmental Psychiatry, University of Nottingham, Nottingham, UK.

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.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Adolescent
Behavior Therapy / methods*
Child
Cost-Benefit Analysis
Humans
Internet*
Pilot Projects
Quality of Life
Randomized Controlled Trials as Topic
Severity of Illness Index
Single-Blind Method
Tic Disorders / therapy*
Tics / therapy*

Associated data

ClinicalTrials.gov/NCT03483493
ISRCTN/ISRCTN70758207

Abstract

Publication types

MeSH terms

Associated data

Grants and funding