Condition category
Mental and Behavioural Disorders
Date applied
19/03/2018
Date assigned
20/03/2018
Last edited
13/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Tourette's syndrome is a condition where a person makes involuntary sounds and movements called tics. This study is comparing the effectiveness of two treatments delivered online for children and young people with Tourette’s syndrome or chronic tic disorder. The aim is to find out whether a therapist-guided, parent-assisted online intervention helps children and young people to 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.

Who can participate?
Families in England with a child/young person (aged 9-17) who experiences tics

What does the study involve?
Interested families undergo a telephone interview with a researcher and are then asked to complete an online questionnaire. They then attend an appointment at either Great Ormond Street Hospital (London) or Queen’s Medical Centre (Nottingham). Families 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, and 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.

What are the possible benefits and risks of participating?
It is important to research online treatment for tics because, at the moment, many people with tics do not get any treatment 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. Both groups receive an intervention which offers support for tics beyond that typically available for most patients with tics. The therapy content itself has been well established, it is the method of delivery (online) that is being investigated. Families are asked to attend a face-to-face assessment, but they are reimbursed for all their travel costs, even if they do not join the study. Families are also asked to complete questionnaires at different time points in the study, but they are reimbursed for their time in the form of £20 worth of vouchers. They are able to complete the follow-up questionnaires at home, reducing the burden. This is a low risk intervention and there are no anticipated serious side effects. Also, participants undergo a thorough assessment before joining the study which decreases the risk of patients in need of more extensive care (e.g. risk management) being included in the study. The participants have contact with both the therapist and the researcher during the 10-week treatment, so are closely monitored for any potential side effects.

Where is the study run from?
1. Queens Medical Centre (UK)
2. Great Ormond Street Hospital (UK)

When is the study starting and how long is it expected to run for?
October 2017 to September 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Charlotte Hall

Trial website

Contact information

Type

Scientific

Primary contact

Dr Charlotte Hall

ORCID ID

http://orcid.org/0000-0002-5412-6165

Contact details

Division of Psychiatry & Applied Psychology
Institute of Mental Health
University of Nottingham Innovation Park
Triumph Road
Nottingham
NG7 2TU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT03483493

Protocol/serial number

37415

Study information

Scientific 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

Acronym

ORBIT

Study hypothesis

Does a therapist-guided, parent-assisted online intervention improve tics in children and adolescents with Tourette syndrome or chronic tic disorder?

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.

Ethics approval

Greater Manchester Central (NRES Committee North West), 23/03/2018, ref: 18/NW/0079

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Children, Primary sub-specialty: Neurosciences; UKCRC code/ Disease: Mental Health/ Behavioural and emotional disorders with onset usually occurring in childhood and adolescence

Intervention

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.

The Tourette-focused intervention involves the parent & young person completing 10 chapters online over 10 weeks. The chapters will be delivered online via the BiP web-based platform and can be completed in the participants own home. Participants have remote regular contact with an experienced, trained therapist via messages sent inside the treatment platform (resembling an email). The therapist can directly comment on exercises that the patient has been working on, and give specific feedback to motivate the participant. The psychoeducational information intervention involves the parent & young person completing 10 chapters. The chapters will be delivered online via the BiP web-based platform and can be completed in the participant's own home. Participants have remote regular contact with an experienced, trained therapist via messages sent inside the treatment platform (resembling an email). The therapist can directly comment on exercises that the patient has been working on, and give specific feedback to motivate the participant.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Tic disorder symptoms assessed using the Yale Global Tic Severity Scale (YGTSS) - Total Tic score; Timepoint(s): Baseline, 3, 6, 12 and 18 months

Secondary outcome measures

1. Number, frequency and intensity of motor/vocal tics measured using the Parent Tic Questionnaire at baseline, 5 weeks, 3 months, 6 months, 12 months and 18 months
2. Symptom severity/improvement measured using the Clinical Global Impressions Scale at 3, 6, 12 and 18 months
3. Tic distress and impairment measured using the Yale Global Tic Severity Scale Impairment Scale at baseline, 3, 6, 12 and 18 months
4. Global functioning measured using the Children's Global Assessment Scale at baseline, 3, 6, 12 and 18 months
5. General functioning measured using the Strengths and Difficulties Questionnaire at baseline, 3, 6, 12 and 18 months
6. Mood measured using the Mood and Feelings Questionnaire at baseline, 1, 3, 6, 12 and 18 months
7. Anxiety symptoms measured using the Spence Child Anxiety Scale at baseline, 3, 6, 12 and 18 months
8. Quality of life measured using the Child Health Utility 9D at baseline, 3, 6, 12 and 18 months
9. Tic-related quality of life measured using the Child and Adolescent Gilles de la Tourette Syndrome at baseline, 3, 6, 12 and 18 months
10. Use of services measured using the Modified Client Service Receipt Inventory at baseline, 3, 6, 12 and 18 months
11. Side effects measured using the adverse events/side effects 17-item scale at baseline, 1, 3, 6, 12 & 18 months
12. Participants' perception of treatment credibility measured using a specifically created 'treatment credibility' questionnaire at 3 weeks
13. Participants' perception of treatment satisfaction measured using a specifically created 'treatment satisfaction' questionnaire at 3 months
14. Participants' perception of their need for further treatment measured using a specifically created 'Need for further treatment' questionnaire at 3 months
15. Participants' change of use of other medication/interventions measured using a specifically created 'Concomitant interventions' questionnaire at baseline, 3, 6, 12 and 18 months

The following measures are used at screening/baseline but may be reported in the final report to describe the sample characteristics in the results section:
16. Sample characteristics described using the Development and Wellbeing Assessment (DAWBA) at screening/baseline
17. Presence of an intellectual disability assessed using the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q) at screening/baseline
18. Characteristics of the sample assessed using a specifically created demographics questionnaire at screening/baseline
19. Presence of Autism Spectrum Disorder assessed using the Social Communication Questionnaire (SCQ) at screening/baseline
20. Premonitory urges for tics assessed using the Premonitory Urge for Tics Scale (PUTS) at screening/baseline
21. ADHD symptoms assessed using the Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at screening/baseline

Other pre-specified outcome measures:
22. Process evaluation of the interventions using qualitative interviews in a subsample of participants at 3 months

Added 13/04/2018: A record of therapist time, parent and child logins and frequency of therapist contact will also be analysed as part of the process evaluation

Overall trial start date

01/10/2017

Overall trial end date

30/09/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 9 to 17
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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 220; UK Sample Size: 220

Participant 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

Recruitment start date

25/04/2018

Recruitment end date

01/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queens Medical Centre/University of Nottingham (lead site)
Division of Psychiatry and Applied Psychology E Floor South Block
Nottingham
NG7 2UH

Trial participating centre

Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH

Sponsor information

Organisation

Nottinghamshire Healthcare NHS Foundation Trust

Sponsor details

c/o Shirley Mitchell
Duncan Macmillan House
Porchester Road
Mapperely
Nottingham
NG3 6AA
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 16/19/02

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The study protocol will be published once ethical approval is received. There are no plans to date to publish the statistical analysis plan, however, this may change. At the moment, the statistical analysis plan is available on request from Dr Charlotte Hall. The trialists plan to publish the results of the trial in high-impact peer reviewed journals and present the findings at relevant national and international conferences. They plan to have published the main trial findings by the end of 2022.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/12/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/04/2018: The recruitment start date was changed from 01/04/2018 to 25/04/2018, and an addition was made to the secondary outcome measures. 29/03/2018: ClinicalTrials.gov number added. 23/03/2018: Ethics approval information added.