Tic disorders Mental and Behavioural Disorders
Conditions
Interventions
ORBIT-UK is a web-based platform that has been specifically designed for use by children and young people, with age-appropriate appearance, animations, and interactive scripts, developed and hosted by
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Age
9 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1. Aged 9 to 17 years: patient confirmed at screening. 2. Suspected or confirmed Tourette syndrome/chronic tic disorder: Including moderate/severe tics with a score >15 on the Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS); TTSS score >10 if motor or vocal tics only. Coach will assess this at initial assessment via video conference. 3. Competent to provide written, informed consent (parental consent for child aged <16): referring clinician confirms at screening appointment. 4. Broadband internet access and regular PC/laptop/Mac/mobile device user, with mobile phone SMS: patient confirmed at screening. 5. Clinical suitability for ORBIT confirmed by referrer from patient’s usual care team. 6. A parent, carer or legal guardian aged 18+ who is willing and able to act as a Supporter. 7. Supporters: A Supporter can be a parent, caregiver, or legal guardian chosen by the Young Person. They must be at least 18 years of age or over and have capacity to support the Young Person through the intervention. 8. Clinicians: Only clinicians who appear on the ORBIT-UK site delegation log will be eligible to be approached to be interviewed. 9. Coaches: Only Coaches who appear on the ORBIT-UK site delegation log will be eligible to be approached to be interviewed.
Exclusion criteria
Exclusion criteria: 1. Presentation of functional tics (Functional Neurological Disorder) 2. Moderate/severe intellectual disability: Confirmed through qualitative judgement of the referrer from the patients' usual care team. 3. Immediate risk to self or others: Confirmed through referrer from the patients’ usual care team. 4. Parent or child not able to speak or read/write English: Patient confirmed through screening by the referring clinician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Tic severity is measured using the Parent Tic Questionnaire (PTQ) at baseline, mid-intervention (Week 5), and end of intervention (Week 8) 2. Health-related quality of life is measured using the Child and Adolescent Gilles de la Tourette Syndrome - Quality of Life Scale (C&A GTS-QoL) at baseline and end of intervention (Week 8) 3. Usability of the platform is measured using the System Usability Scale (SUS) at end of intervention (Week 8) 4. Satisfaction with the intervention is measured using the ORBIT satisfaction questionnaire at end of intervention (Week 8) 5. Global symptom improvement is measured using the Clinical Global Impression - Improvement scale (CGI-I) at Week 10–12 6. Tic severity is measured using the Yale Global Tic Severity Scale (YGTSS) at Week 10–12 7. Goal-based outcomes progress is measured using participant self-report at the end of each chapter during the intervention period 8. Chapter usability is measured using a chapter usability rating at the end of each chapter during the intervention period 9. Adverse events are monitored using the in-built ‘Report AE’ function throughout the intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| Qualitative feedback on usability, acceptability and preliminary effectiveness is measured using semi-structured interviews at end of intervention (Week 10–12) | — |
Countries
England, United Kingdom
Contacts
Public ContactBev Brown
Outcome results
None listed