Status:
COMPLETED
Online Remote Behavioural Intervention for Tics (ORBIT)
Lead Sponsor:
Nottinghamshire Healthcare NHS Trust
Collaborating Sponsors:
University College, London
Karolinska Institutet
Conditions:
Tic Disorders
Tourette Syndrome
Eligibility:
All Genders
9-17 years
Phase:
NA
Brief 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 ...
Detailed Description
The ORBIT (Online Remote Behavioural Intervention for Tics) trial is comparing the effectiveness of two treatments delivered online for children and young people with Tourette Syndrome or Chronic Tic ...
Eligibility Criteria
Inclusion
- Aged 9 to 17: patient confirmed through screening.
- Suspected or confirmed Tourette syndrome/ chronic tic disorder:
- \- Including Moderate/severe tics: Score \>15 on the Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS); TTSS score\>10 if motor or vocal tics only: researcher confirms at screening appointment
- Competent to provide written, informed consent (parental consent for child aged \<16): researcher confirms at screening appointment.
- Broadband internet access and regular PC/ laptop/Mac user, with mobile phone SMS: patient confirmed through screening.
Exclusion
- Previous structured behavioural intervention for tics e.g. HRT/CBIT or exposure and response prevention within last 12 months: Patient confirmed through screening.
- Change to medication for tics (start or stop tic medication) within the previous 2 months: Patient confirmed through screening and subsequent medication/interventions commenced throughout out the trial are recorded at each time point for analysis.
- Diagnoses of alcohol/substance dependence, psychosis, suicidality, or anorexia nervosa: Confirmed through parent DAWBA. DAWBAs that score people as being likely to have these conditions will be second reviewed by the CI (who is a medical expert) to ascertain that they should definitely be excluded from the trial. If the child is considered at immediate risk of suicide, the research team will inform the GP or usual treating clinician.
- Moderate/severe intellectual disability: Confirmed through qualitative judgement of the assessor at the telephone screen (and confirmed at baseline through CAIDS-Q) through questions relating to type of school the child attends and previous diagnoses.
- Immediate risk to self or others: Confirmed through screening questions and DAWBA. The participants GP will be informed of this.
- Parent or child not able to speak or read/write English: Patient confirmed through screening by the assessor.
Key Trial Info
Start Date :
May 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2021
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT03483493
Start Date
May 7 2018
End Date
April 12 2021
Last Update
September 9 2021
Active Locations (1)
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1
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham, United Kingdom