Online Remote Behavioural Intervention for Tics (ORBIT)

NCT03483493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2021-09-09

No results posted yet for this study

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
  • Karolinska Institutet

    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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03483493 on ClinicalTrials.gov