Tic DisordersORBITNCT03483493
Online Remote Behavioural Intervention for Tics (ORBIT)
A study testing Exposure Response Prevention for tics and Psychoeducation for tics in people with Tic Disorders and Tourette Syndrome, run by Nottinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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 intervention for tics in young people, compared with usual care plus online education. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Tic Disorders, Tourette Syndrome
- What is being tested?
- Exposure Response Prevention for tics and Psychoeducation for tics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 May 2018to 12 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottinghamshire Healthcare NHS Foundation Trust
Nottingham
About this study
Official title: 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
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.
Read the 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 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.
- Conditions
- Tic Disorders, Tourette Syndrome
- Being tested
- Exposure Response Prevention for tics, Psychoeducation for tics
- Keywords
- Tic disorders, Tourette Syndrome, Online delivered therapy
- Medical subject headings
- Tic Disorders, Tourette Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure Response Prevention for ticsBehavioural
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'.
Psychoeducation for ticsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure Response Prevention for tics | Experimental | 10-weeks, online delivered, therapist supported exposure response prevention (ERP) therapy for tics Receives: Behavioral: Exposure Response Prevention for tics |
| Active Control (Psychoeducation) | Active comparator | 10-weeks, online delivered, therapist supported psychoeducation for tics Receives: Other: Psychoeducation for tics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, 3, 6, 12 and 18 months
Secondary outcomes (21)
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
Measured: Baseline, 5wks, 3mths, 6mths, 12mths & 18 months
Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale.
Clinician determined measure that summarises the patient's history, symptoms, behaviours and psychosocial circumstances
Measured: 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
Measured: 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
Measured: 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".
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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/
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Screening/Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start7 May 2018
- Primary completion18 Feb 2020
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Tic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottinghamshire Healthcare NHS Trust
- Sponsor type
- Other government
- Collaborators
- University College, London, Karolinska Institutet, National Institute for Health Research, United Kingdom, Great Ormond Street Hospital for Children NHS Foundation Trust, University of Nottingham
- Responsible party
- Sponsor
- Investigators
- Chris Hollis, MD, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03483493
- Sponsor's protocol ID
- Hollis201117
- Acronym
- ORBIT
- Status last verified
- Sep 2021
- First submitted
- 12 Mar 2018
- Last updated
- 9 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available for use by researchers with a sound research idea from priment@ucl.ac.uk
Publications
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.
PubMed 34480868Hall 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.
PubMed 39515845Hollis 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.
PubMed 37924247Hollis 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.
PubMed 36649686Hall 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.
PubMed 35416566Hall 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.
PubMed 33298127Khan 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.
PubMed 31898510Hall 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.
PubMed 30610027
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03483493
- Acronym / sponsor ID
- ORBIT / Hollis201117
- Conditions
- Tic Disorders, Tourette Syndrome
- Keywords
- Tic disorders, Tourette Syndrome, Online delivered therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Nottinghamshire Healthcare NHS TrustOther government
- Collaborators
- University College, London, Karolinska Institutet, National Institute for Health Research, United Kingdom, Great Ormond Street Hospital for Children NHS Foundation Trust, University of Nottingham
- Study start
- 7 May 2018 (actual)
- Primary completion
- 18 Feb 2020 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure Response Prevention for tics | Experimental | Behavioral: Exposure Response Prevention for tics10-weeks, online delivered, therapist supported exposure response prevention (ERP) therapy for tics |
| Active Control (Psychoeducation) | Active comparator | Other: Psychoeducation for tics10-weeks, online delivered, therapist supported psychoeducation for tics |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 9 to 17: patient confirmed through screening.
- Suspected or confirmed Tourette syndrome/ chronic tic disorder:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure Response Prevention for ticsThe 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'. | Behavioural | Exposure Response Prevention for tics |
| Psychoeducation for ticsThe 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. | Other | Active Control (Psychoeducation) |
Primary outcome
Assessing change in tics in participants using the Yale Global Tic Severity Scale - Total Tic score
Time frame: Baseline, 3, 6, 12 and 18 months
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
21 secondary outcomes
Assessing change in tics in participants using the Parent Tic Questionnaire
Time frame: Baseline, 5wks, 3mths, 6mths, 12mths & 18 months
Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale.
Time frame: 3, 6, 12 & 18 months
Assessing change in tic impairment in participants using the Yale Global Tic Severity Scale Impairment Scale (assessing change)
Time frame: Baseline, 3, 6, 12 & 18 months
Assessing change in global functioning in participants using the Children's Global Assessment Scale
Time frame: Baseline, 3, 6, 12 & 18 months
Assessing change in general functioning in participants using the Strengths and Difficulties Questionnaire
Time frame: Baseline, 3, 6, 12 & 18 months
Assessing change in mood in participants using the Mood and Feelings Questionnaire
Time frame: Baseline, 1, 3, 6, 12 & 18 months
Assessing change in anxiety in participants using the Spence Child Anxiety Scale
Time frame: Baseline, 3, 6, 12 & 18 months
Assessing change in quality of life in participants using the Child Health Utility 9D
Time frame: 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
Time frame: Baseline, 3, 6, 12 & 18 months
Assessing participants change in use of services using the Modified Client Service Receipt Inventory
Time frame: Baseline, 3, 6, 12 & 18 months
Assessing change in side effects in participants using the Adverse events/side effects
Time frame: Baseline, 1, 3, 6, 12 & 18 months
Assessing participants perception of treatment credibility using a specifically created 'treatment credibility' questionnaire
Time frame: 3 weeks
Assessing participants perception of treatment satisfaction using a specifically created 'treatment satisfaction' questionnaire
Time frame: 3 months
Assessing participants perception of their need for further treatment using a specifically created 'Need for further treatment' questionnaire
Time frame: 3 months
Assessing participants change of use of other medication/interventions using a specifically created 'Concomitant interventions' questionnaire
Time frame: Baseline, 3, 6, 12 & 18 months
Describing sample characteristics using Development and Wellbeing Assessment (DAWBA) at screening/baseline
Time frame: Screening/Baseline
Determining presence of an intellectual disability at screening/baseline using the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q)
Time frame: Screening/Baseline
Understanding the characteristics of the sample a specifically created demographics questionnaire at screening/baseline
Time frame: Screening/Baseline
Determining the for presence of Autism Spectrum Disorder using the Social Communication Questionnaire (SCQ) at screening/baseline
Time frame: Screening/Baseline
Assessing Premonitory urges for tics using the Premonitory Urge for Tics Scale (PUTS) at screening/baseline
Time frame: Screening/Baseline
Assessing ADHD symptoms using the Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at screening/baseline
Time frame: Screening/Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
- Results publication: PubMed 34480868Hollis 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.
- Derived from this study: PubMed 39515845Hall 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.
- Derived from this study: PubMed 37924247Hollis 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.
- Derived from this study: PubMed 36649686Hollis 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.
- Derived from this study: PubMed 35416566Hall 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.
- Derived from this study: PubMed 33298127Hall 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.
- Derived from this study: PubMed 31898510Khan 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.
- Derived from this study: PubMed 30610027Hall 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.
- Individual participant dataSharing planned: Yes. Data are available for use by researchers with a sound research idea from priment@ucl.ac.uk
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Hollis, MD, PhD principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Response Prevention for tics and Psychoeducation for tics in people with Tic Disorders and Tourette Syndrome, run by Nottinghamshire Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing change in tics in participants using the Yale Global Tic Severity Scale - Total Tic score (time frame: Baseline, 3, 6, 12 and 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03483493, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2021.