Online Remote Behavioural Intervention for Tics (ORBIT)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-07

Study Completion Date

2021-04-12

Brief Summary

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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.

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Detailed Description

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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

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Tic Disorders Tourette Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Exposure Response Prevention for tics

10-weeks, online delivered, therapist supported exposure response prevention (ERP) therapy for tics

Group Type EXPERIMENTAL

Exposure Response Prevention for tics

Intervention Type 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'.

Active Control (Psychoeducation)

10-weeks, online delivered, therapist supported psychoeducation for tics

Group Type ACTIVE_COMPARATOR

Psychoeducation for tics

Intervention Type 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.

Interventions

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Exposure Response Prevention for tics

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'.

Intervention Type BEHAVIORAL

Psychoeducation for tics

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No