Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT03483493
Eligibility Criteria:
Inclusion Criteria:
1. Aged 9 to 17: patient confirmed through screening.
2. 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
3. Competent to provide written, informed consent (parental consent for child aged \<16): researcher confirms at screening appointment.
4. Broadband internet access and regular PC/ laptop/Mac user, with mobile phone SMS: patient confirmed through screening.
Exclusion Criteria:
1. Previous structured behavioural intervention for tics e.g. HRT/CBIT or exposure and response prevention within last 12 months: Patient confirmed through screening.
2. 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.
3. 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.
4. 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.
5. Immediate risk to self or others: Confirmed through screening questions and DAWBA. The participants GP will be informed of this.
6. Parent or child not able to speak or read/write English: Patient confirmed through screening by the assessor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
17 Years
Study:
NCT03483493
Study Brief:
Protocol Section:
NCT03483493