Online Remote Behavioural Intervention for Tics (ORBIT)

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Brief Title

Online Remote Behavioural Intervention for Tics (ORBIT)

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

Brief 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.

      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 Type

Interventional


Primary Outcome

Assessing change in tics in participants using the Yale Global Tic Severity Scale - Total Tic score

Secondary Outcome

 Assessing change in tics in participants using the Parent Tic Questionnaire

Condition

Tic Disorders

Intervention

Exposure Response Prevention for tics

Study Arms / Comparison Groups

 Exposure Response Prevention for tics
Description:  10-weeks, online delivered, therapist supported exposure response prevention (ERP) therapy for tics

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

224

Start Date

May 7, 2018

Completion Date

September 30, 2021

Primary Completion Date

February 18, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

9 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Chris Hollis, MD, PhD, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT03483493

Organization ID

Hollis201117


Responsible Party

Sponsor

Study Sponsor

Nottinghamshire Healthcare NHS Trust

Collaborators

 University College, London

Study Sponsor

Chris Hollis, MD, PhD, Principal Investigator, University of Nottingham


Verification Date

February 2021