TY - JOUR
T1 - Investigating a therapist-guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents - 'Online Remote Behavioural Intervention for Tics' (ORBIT) trial
T2 - Protocol of an internal pilot study and single-blind randomised controlled trial
AU - Hall, Charlotte Lucy
AU - Davies, E. Bethan
AU - Andrén, Per
AU - Murphy, Tara
AU - Bennett, Sophie
AU - Brown, Beverley J.
AU - Brown, Susan
AU - Chamberlain, Liam
AU - Craven, Michael P.
AU - Evans, Amber
AU - Glazebrook, Cristine
AU - Heyman, Isobel
AU - Hunter, Rachael
AU - Jones, Rebecca
AU - Kilgariff, Joseph
AU - Marston, Louise
AU - Mataix-Cols, David
AU - Murray, Elizabeth
AU - Sanderson, Charlotte
AU - Serlachius, Eva
AU - Hollis, Chris
N1 - Funding Information:
Funding This research was funded by the NIHR Heath Technology Assessment (HTA) (Ref 16/19/02). MPC, SB, EBD, CG and CH acknowledge the financial support of the NIHR Nottingham Biomedical Research Centre and NIHR MindTech MedTech Co-operative.
Publisher Copyright:
© © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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.
AB - 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.
KW - behaviour therapy
KW - exposure and response prevention
KW - internet
KW - persistent (chronic) motor or vocal tic disorder
KW - tourette's disorder
UR - http://www.scopus.com/inward/record.url?scp=85059500910&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2018-027583
DO - 10.1136/bmjopen-2018-027583
M3 - Article
C2 - 30610027
AN - SCOPUS:85059500910
SN - 2044-6055
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 1
M1 - e027583
ER -