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
(2019) In BMJ Open 9(1).- 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,... (More)
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.
(Less)
- author
- author collaboration
- publishing date
- 2019-01-01
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- behaviour therapy, exposure and response prevention, internet, persistent (chronic) motor or vocal tic disorder, tourette's disorder
- in
- BMJ Open
- volume
- 9
- issue
- 1
- article number
- e027583
- publisher
- BMJ Publishing Group
- external identifiers
-
- scopus:85059500910
- pmid:30610027
- ISSN
- 2044-6055
- DOI
- 10.1136/bmjopen-2018-027583
- language
- English
- LU publication?
- no
- additional info
- Publisher Copyright: © © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. Published by BMJ.
- id
- 0d14e372-a23d-4e7b-9474-9d63d4912dec
- date added to LUP
- 2023-07-14 11:48:37
- date last changed
- 2024-06-15 04:39:36
@article{0d14e372-a23d-4e7b-9474-9d63d4912dec,
abstract = {{<p>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.</p>}},
author = {{Hall, Charlotte Lucy and Davies, E. Bethan and Andrén, Per and Murphy, Tara and Bennett, Sophie and Brown, Beverley J. and Brown, Susan and Chamberlain, Liam and Craven, Michael P. and Evans, Amber and Glazebrook, Cristine and Heyman, Isobel and Hunter, Rachael and Jones, Rebecca and Kilgariff, Joseph and Marston, Louise and Mataix-Cols, David and Murray, Elizabeth and Sanderson, Charlotte and Serlachius, Eva and Hollis, Chris}},
issn = {{2044-6055}},
keywords = {{behaviour therapy; exposure and response prevention; internet; persistent (chronic) motor or vocal tic disorder; tourette's disorder}},
language = {{eng}},
month = {{01}},
number = {{1}},
publisher = {{BMJ Publishing Group}},
series = {{BMJ Open}},
title = {{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}},
url = {{http://dx.doi.org/10.1136/bmjopen-2018-027583}},
doi = {{10.1136/bmjopen-2018-027583}},
volume = {{9}},
year = {{2019}},
}