Online Remote Behavioural Intervention for Tics (ORBIT)

Nottinghamshire Healthcare NHS Trust

Status

Completed

Conditions

Tourette Syndrome

Tic Disorders

Treatments

Behavioral: Exposure Response Prevention for tics

Other: Psychoeducation for tics

Study type

Interventional

Funder types

Other

Identifiers

NCT03483493

Hollis201117

Details and patient eligibility

About

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.

Full 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.

Enrollment

224 patients

Sex

All

Ages

9 to 17 years old

Volunteers

No Healthy Volunteers

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

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.