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| Name | Class |
|---|---|
| University College, London | OTHER |
| Karolinska Institutet | OTHER |
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Great Ormond Street Hospital for Children NHS Foundation Trust |
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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.
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 Disorder. Families in England with a child/young person (aged 9-17 years) who experiences tics are being asked to take part. Interested families undergo a telephone screen with a researcher and then asked to complete an online questionnaire. They then attend a screening appointment at either Great Ormond Street Hospital (London) or Queen's Medical Centre (Nottingham).
Families that are eligible and want to take part are randomly allocated to one of two treatments. One treatment uses behavioural therapy (BT), the other involves psychoeducation. Both treatments last for 10-weeks and involve completing online chapters (for the parent and child) with the support of a therapist, there are also some tasks to complete offline. After finishing the treatment, families are asked to complete more questionnaires (at 3, 6, 12 and 18 months after starting the treatment). A smaller sample of families and healthcare professionals are also interviewed about their experience of participation. The study is looking to see if the online delivered treatment may be effective at helping children and young people manage their tics. The study is also exploring whether the online programme is acceptable to families, identifying any problems in getting families to take part/complete the programme and also healthcare professionals' views about the programme. It is important to research online therapy for tics because, at the moment, many people with tics do not get any therapy because there are not enough trained tic therapists. If online delivered treatment is effective, this may mean more children and young people could access tic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure Response Prevention for tics | Experimental | 10-weeks, online delivered, therapist supported exposure response prevention (ERP) therapy for tics |
|
| Active Control (Psychoeducation) | Active Comparator | 10-weeks, online delivered, therapist supported psychoeducation for tics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure Response Prevention for tics | Behavioral | 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing change in tics in participants using the Yale Global Tic Severity Scale - Total Tic score | Investigator administered semi structured symptom checklist of 46 tic disorder symptoms. The Total Tic Score is derived by adding the Total Motor Tic Score and the Total Phonic Tic Score | Baseline, 3, 6, 12 and 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessing change in tics in participants using the Parent Tic Questionnaire | Self administered questionnaire to collect the number, frequency and intensity of 14 common motor and 14 common vocal tics | Baseline, 5wks, 3mths, 6mths, 12mths & 18 months |
| Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the process evaluation of the interventions qualitative interviews will be conducted | A sub-sample of participants will be as asked to participate in qualitative interviews as part of a process evaluation. | 3months |
Inclusion Criteria:
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 Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Hollis, MD, PhD | University of Nottingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottinghamshire Healthcare NHS Foundation Trust | Nottingham | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34480868 | Result | Hollis C, Hall CL, Jones R, Marston L, Novere ML, Hunter R, Brown BJ, Sanderson C, Andren P, Bennett SD, Chamberlain LR, Davies EB, Evans A, Kouzoupi N, McKenzie C, Heyman I, Khan K, Kilgariff J, Glazebrook C, Mataix-Cols D, Murphy T, Serlachius E, Murray E. Therapist-supported online remote behavioural intervention for tics in children and adolescents in England (ORBIT): a multicentre, parallel group, single-blind, randomised controlled trial. Lancet Psychiatry. 2021 Oct;8(10):871-882. doi: 10.1016/S2215-0366(21)00235-2. Epub 2021 Sep 1. | |
| 39515845 |
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Data are available for use by researchers with a sound research idea from priment@ucl.ac.uk
Data will be made available beginning 3 months and ending 5 years after the specified trial outcome paper(s) is/are published.
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| ID | Term |
|---|---|
| D013981 | Tic Disorders |
| D005879 | Tourette Syndrome |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D065886 | Neurodevelopmental Disorders |
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| OTHER |
| University of Nottingham | OTHER |
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|
| Psychoeducation for tics | Other | 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. |
|
Clinician determined measure that summarises the patient's history, symptoms, behaviours and psychosocial circumstances |
| 3, 6, 12 & 18 months |
| Assessing change in tic impairment in participants using the Yale Global Tic Severity Scale Impairment Scale (assessing change) | This forms part of the YGTSS but focuses on distress and impairment experienced in the individuals life | Baseline, 3, 6, 12 & 18 months |
| Assessing change in global functioning in participants using the Children's Global Assessment Scale | A measure of psychiatric disturbance integrating psychological, social and academic functioning | Baseline, 3, 6, 12 & 18 months |
| Assessing change in general functioning in participants using the Strengths and Difficulties Questionnaire | Self-report, parent completed questionnaire measuring behavioural and emotional difficulties in children. The baseline SDQ is completed as part of a screening tool "DAWBA". | Baseline, 3, 6, 12 & 18 months |
| Assessing change in mood in participants using the Mood and Feelings Questionnaire | Child completed, self-report questionnaire collecting information on depressive symptoms | Baseline, 1, 3, 6, 12 & 18 months |
| Assessing change in anxiety in participants using the Spence Child Anxiety Scale | Self-report child completed questionnaire evaluating symptoms of separation anxiety, social phobia, obsessive-compulsive disorder, pain, agoraphobia, generalised anxiety and fear of physical injury | Baseline, 3, 6, 12 & 18 months |
| Assessing change in quality of life in participants using the Child Health Utility 9D | Self-report parent and child completed quality of life measure | Baseline, 3, 6,12,18 months |
| Assessing change in tic-related quality of life in participants using the Child and Adolescent Gilles de la Tourette Syndrome | A disease specific measure of health related quality of life for children and adolescents with Tourette Syndrome. There are two version, one for children aged 6-12 years and a second for young people aged 3-8 years | Baseline, 3, 6, 12 & 18 months |
| Assessing participants change in use of services using the Modified Client Service Receipt Inventory | A questionnaire to collect information on services received, service related issues, school attendance and family income | Baseline, 3, 6, 12 & 18 months |
| Assessing change in side effects in participants using the Adverse events/side effects | A 17 item scale of common side effects | Baseline, 1, 3, 6, 12 & 18 months |
| Assessing participants perception of treatment credibility using a specifically created 'treatment credibility' questionnaire | A two item questionnaire to assess how well the treatment suits children, according to the perception of the 1) parent/carer and 2) child/young person | 3 weeks |
| Assessing participants perception of treatment satisfaction using a specifically created 'treatment satisfaction' questionnaire | A 7 item scale questionnaire developed for the study to assess treatment satisfaction from the perception of the 1) parent/carer and 2) child/young person | 3 months |
| Assessing participants perception of their need for further treatment using a specifically created 'Need for further treatment' questionnaire | A single item questionnaire asking if the child or young person requires more treatment for their tics from the perception of the 1) parent/carer and 2) child/young | 3 months |
| Assessing participants change of use of other medication/interventions using a specifically created 'Concomitant interventions' questionnaire | Assessment of any other treatment or interventions the child or young person is accessing during the study | Baseline, 3, 6, 12 & 18 months |
| Describing sample characteristics using Development and Wellbeing Assessment (DAWBA) at screening/baseline | The DAWBA is a package of interviews and questionnaires completed by parents and teachers and designed to generate ICD-10 and DSM-IV / DSM-5 psychiatric diagnoses for children and young people. | Screening/Baseline |
| Determining presence of an intellectual disability at screening/baseline using the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q) | A 7-item questionnaire to determine the presence of intellectual disability at screening/baseline, completed by the parent/ | Screening/Baseline |
| Understanding the characteristics of the sample a specifically created demographics questionnaire at screening/baseline | Parent completed questionnaire asking about the child's age, gender, ethnicity, parental education/ occupation, list of the child's current diagnoses and interventions (including medications) and GP and school details. | Screening/Baseline |
| Determining the for presence of Autism Spectrum Disorder using the Social Communication Questionnaire (SCQ) at screening/baseline | A 40 item, parent-report questionnaire asking about characteristic autistic behaviour at the age of 4 to 5 years and currently. | Screening/Baseline |
| Assessing Premonitory urges for tics using the Premonitory Urge for Tics Scale (PUTS) at screening/baseline | A self-report instrument specifically designed to measure the current frequency of different types of premonitory urges in patients with tic disorders | Screening/Baseline |
| Assessing ADHD symptoms using the Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at screening/baseline | A parent completed 26-item behavioural rating scale that employs the core symptoms of ADHD and oppositional defiance disorder (ODD) as defined by the Diagnostic and Statistical Manual of Mental Disorders. | Screening/Baseline |
| Derived |
| Hall CL, Le Novere M, Murphy T, McNally E, Hollis C, Hunter R. Healthcare utilisation and costs associated with poor access to diagnosis and treatment for children and young people with tic disorders. BMJ Ment Health. 2024 Nov 7;27(1):e301241. doi: 10.1136/bmjment-2024-301241. |
| 37924247 | Derived | Hollis C, Hall CL, Khan K, Le Novere M, Marston L, Jones R, Hunter R, Brown BJ, Sanderson C, Andren P, Bennett SD, Chamberlain LR, Davies EB, Evans A, Kouzoupi N, McKenzie C, Heyman I, Kilgariff J, Glazebrook C, Mataix-Cols D, Serlachius E, Murray E, Murphy T. Online remote behavioural intervention for tics in 9- to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation. Health Technol Assess. 2023 Oct;27(18):1-120. doi: 10.3310/CPMS3211. |
| 36649686 | Derived | Hollis C, Hall CL, Khan K, Jones R, Marston L, Le Novere M, Hunter R, Andren P, Bennett SD, Brown BJ, Chamberlain LR, Davies EB, Evans A, Kouzoupi N, McKenzie C, Sanderson C, Heyman I, Kilgariff J, Glazebrook C, Mataix-Cols D, Serlachius E, Murray E, Murphy T. Long-term clinical and cost-effectiveness of a therapist-supported online remote behavioural intervention for tics in children and adolescents: extended 12- and 18-month follow-up of a single-blind randomised controlled trial. J Child Psychol Psychiatry. 2023 Jun;64(6):941-951. doi: 10.1111/jcpp.13756. Epub 2023 Jan 17. |
| 35416566 | Derived | Hall CL, Marston L, Khan K, Brown BJ, Sanderson C, Andren P, Bennett S, Heyman I, Mataix-Cols D, Serlachius E, Hollis C, Murphy T. The COVID-19 pandemic and its impact on tic symptoms in children and young people: a prospective cohort study. Child Psychiatry Hum Dev. 2023 Dec;54(6):1499-1509. doi: 10.1007/s10578-022-01348-1. Epub 2022 Apr 13. |
| 33298127 | Derived | Hall CL, Sanderson C, Brown BJ, Andren P, Bennett S, Chamberlain LR, Davies EB, Khan K, Kouzoupi N, Mataix-Cols D, McKenzie C, Murphy T, Townsend M, Hollis C, Murray E. Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people. Trials. 2020 Dec 9;21(1):1011. doi: 10.1186/s13063-020-04902-1. |
| 31898510 | Derived | Khan K, Hollis C, Hall CL, Davies EB, Mataix-Cols D, Andren P, Murphy T, Brown BJ, Murray E, Glazebrook C. Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) randomized controlled trial for children and young people. Trials. 2020 Jan 2;21(1):6. doi: 10.1186/s13063-019-3974-3. |
| 30610027 | Derived | Hall CL, Davies EB, Andren P, Murphy T, Bennett S, Brown BJ, Brown S, Chamberlain L, Craven MP, Evans A, Glazebrook C, Heyman I, Hunter R, Jones R, Kilgariff J, Marston L, Mataix-Cols D, Murray E, Sanderson C, Serlachius E, Hollis C; ORBIT Trial team.. Investigating a therapist-guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents-'Online Remote Behavioural Intervention for Tics' (ORBIT) trial: protocol of an internal pilot study and single-blind randomised controlled trial. BMJ Open. 2019 Jan 3;9(1):e027583. doi: 10.1136/bmjopen-2018-027583. |
| D001523 | Mental Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |