ISRCTN70758207
Completed
未知
Therapist-guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents with Tourette syndrome: an internal pilot study and single-blind randomised controlled trial
ottinghamshire Healthcare NHS Foundation Trust0 sites224 target enrollmentMarch 20, 2018
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Tourette Syndrome or Chronic Tic Disorder
- Sponsor
- ottinghamshire Healthcare NHS Foundation Trust
- Enrollment
- 224
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/30610027 protocol 2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31898510 protocol (added 06/01/2020) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34480868/ (added 06/09/2021) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/35416566/ Comparison of tic symptoms before and during COVID-19 pandemic (added 14/04/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36649686/ outcome results (added 18/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37924247/ (added 06/11/2023)
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Aged 9 to 17 years
- •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
- •3\. Competent to provide written, informed consent (parental consent for child aged \<16\)
- •4\. Broadband internet access and regular PC/laptop/Mac user, with mobile phone SMS
Exclusion Criteria
- •1\. Previous structured behavioural intervention for tics e.g. HRT/CBIT or exposure and response prevention within last 12 months from baseline. Participants may start any new behavioural interventions for tics outside of the trial intervention only after the initial 6 months of the study
- •2\. Change to medication for tics (starting or stopping medication) within the previous 2 months prior to baseline. Participants may start/change medication for tics only after the initial 6 months of the study
- •3\. Diagnosis of alcohol/substance dependence, psychosis, suicidality, or anorexia nervosa
- •4\. Moderate/severe intellectual disability
- •5\. Immediate risk to self or others
- •6\. Parent or child not able to speak or read English
Outcomes
Primary Outcomes
Not specified
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