Online Remote Behavioural Intervention for Tics (ORBIT)
NCT03483493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224
Last updated 2021-09-09
Summary
Online Remote Behavioural Intervention for Tics (ORBIT).
Primary objective: to evaluate the clinical effectiveness of BiP Tic, a therapist-guided, parent-assisted, internet-based behavioural therapy intervention for tics in young people, compared with usual care plus online education.
Secondary objectives include 1) optimising the design of the intervention, 2) undertaking an internal pilot, 3) evaluating cost effectiveness and 4) longer term impact, and 5) identifying barriers to implementation.
Conditions
- Tic Disorders
- Tourette Syndrome
Interventions
- BEHAVIORAL
-
Exposure Response Prevention for tics
The intervention consists of evidence-based interventions adapted from previously published treatment manuals on Exposure and Response Prevention (ERP) and established behavioural intervention for tics protocols. Each of the 10 modules includes age-appropriate texts, animations and exercises. Prticipants are instructed to practice suppressing their tics, this is known as 'response prevention'. Then, with the help of their parent/carer, the participant is instructed to provoke premonitory urges (the urge to tic often felt before the tic is expressed) and try to supress the need to express/demonstrate the tic, this known as 'exposure'.
- OTHER
-
Psychoeducation for tics
The comparator intervention reviews the definition of tics, natural history, common presentations, prevalence, aetiology, risks and protective factors and strategies for describing tics to other people etc. Problem-solving and development of expertise in tic disorders is emphasised. The intervention includes strategies for promoting positive behaviours which will be rewarded by a parent as a parallel element to the tic control practice in the behavioural therapy arm. There is no information on tic control within the management package.
Sponsors & Collaborators
-
University College, London
collaborator OTHER - collaborator OTHER
-
National Institute for Health Research, United Kingdom
collaborator OTHER_GOV -
Great Ormond Street Hospital for Children NHS Foundation Trust
collaborator OTHER -
University of Nottingham
collaborator OTHER -
Nottinghamshire Healthcare NHS Trust
lead OTHER_GOV
Principal Investigators
-
Chris Hollis, MD, PhD · University of Nottingham
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 9 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-07
- Primary Completion
- 2020-02-18
- Completion
- 2021-04-12
Countries
- United Kingdom
Study Locations
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