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Online Remote Behavioural Intervention for Tics (ORBIT) (ORBIT)

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ClinicalTrials.gov Identifier: NCT03483493
Recruitment Status : Not yet recruiting
First Posted : March 30, 2018
Last Update Posted : March 30, 2018
Sponsor:
Collaborators:
University College, London
Karolinska Institutet
NIHR MindTech MedTech Co-operative
Great Ormond Street Hospital for Children NHS Foundation Trust
University of Nottingham
Information provided by (Responsible Party):
Nottinghamshire Healthcare NHS Trust

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.


Condition or disease Intervention/treatment Phase
Tic Disorders Tourette Syndrome Behavioral: Exposure Response Prevention for tics Other: Psychoeducation for tics Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 16, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exposure Response Prevention for tics
10-weeks, online delivered, therapist supported exposure response prevention (ERP) therapy for tics
Behavioral: 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'.

Active Comparator: Active Control (Psychoeducation)
10-weeks, online delivered, therapist supported psychoeducation for tics
Other: 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Assessing change in tics in participants using the Parent Tic Questionnaire [ Time Frame: Baseline, 5wks, 3mths, 6mths, 12mths & 18 months ]
    Self administered questionnaire to collect the number, frequency and intensity of 14 common motor and 14 common vocal tics

  2. Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale. [ Time Frame: 3, 6, 12 & 18 months ]
    Clinician determined measure that summarises the patient's history, symptoms, behaviours and psychosocial circumstances

  3. 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 ]
    This forms part of the YGTSS but focuses on distress and impairment experienced in the individuals life

  4. Assessing change in global functioning in participants using the Children's Global Assessment Scale [ Time Frame: Baseline, 3, 6, 12 & 18 months ]
    A measure of psychiatric disturbance integrating psychological, social and academic functioning

  5. Assessing change in general functioning in participants using the Strengths and Difficulties Questionnaire [ Time Frame: Baseline, 3, 6, 12 & 18 months ]
    Self-report, parent completed questionnaire measuring behavioural and emotional difficulties in children. The baseline SDQ is completed as part of a screening tool "DAWBA".

  6. Assessing change in mood in participants using the Mood and Feelings Questionnaire [ Time Frame: Baseline, 1, 3, 6, 12 & 18 months ]
    Child completed, self-report questionnaire collecting information on depressive symptoms

  7. Assessing change in anxiety in participants using the Spence Child Anxiety Scale [ Time Frame: Baseline, 3, 6, 12 & 18 months ]
    Self-report child completed questionnaire evaluating symptoms of separation anxiety, social phobia, obsessive-compulsive disorder, pain, agoraphobia, generalised anxiety and fear of physical injury

  8. Assessing change in quality of life in participants using the Child Health Utility 9D [ Time Frame: Baseline, 3, 6,12,18 months ]
    Self-report parent and child completed quality of life measure

  9. 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 ]
    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

  10. Assessing participants change in use of services using the Modified Client Service Receipt Inventory [ Time Frame: Baseline, 3, 6, 12 & 18 months ]
    A questionnaire to collect information on services received, service related issues, school attendance and family income

  11. Assessing change in side effects in participants using the Adverse events/side effects [ Time Frame: Baseline, 1, 3, 6, 12 & 18 months ]
    A 17 item scale of common side effects

  12. Assessing participants perception of treatment credibility using a specifically created 'treatment credibility' questionnaire [ Time Frame: 3 weeks ]
    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

  13. Assessing participants perception of treatment satisfaction using a specifically created 'treatment satisfaction' questionnaire [ Time Frame: 3 months ]
    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

  14. Assessing participants perception of their need for further treatment using a specifically created 'Need for further treatment' questionnaire [ Time Frame: 3 months ]
    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

  15. Assessing participants change of use of other medication/interventions using a specifically created 'Concomitant interventions' questionnaire [ Time Frame: Baseline, 3, 6, 12 & 18 months ]
    Assessment of any other treatment or interventions the child or young person is accessing during the study

  16. Describing sample characteristics using Development and Wellbeing Assessment (DAWBA) at screening/baseline [ Time Frame: 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.

  17. Determining presence of an intellectual disability at screening/baseline using the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q) [ Time Frame: Screening/Baseline ]
    A 7-item questionnaire to determine the presence of intellectual disability at screening/baseline, completed by the parent/

  18. Understanding the characteristics of the sample a specifically created demographics questionnaire at screening/baseline [ Time Frame: 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.

  19. Determining the for presence of Autism Spectrum Disorder using the Social Communication Questionnaire (SCQ) at screening/baseline [ Time Frame: Screening/Baseline ]
    A 40 item, parent-report questionnaire asking about characteristic autistic behaviour at the age of 4 to 5 years and currently.

  20. Assessing Premonitory urges for tics using the Premonitory Urge for Tics Scale (PUTS) at screening/baseline [ Time Frame: Screening/Baseline ]
    A self-report instrument specifically designed to measure the current frequency of different types of premonitory urges in patients with tic disorders

  21. Assessing ADHD symptoms using the Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at screening/baseline [ Time Frame: 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.


Other Outcome Measures:
  1. To assess the process evaluation of the interventions qualitative interviews will be conducted [ Time Frame: 3months ]
    A sub-sample of participants will be as asked to participate in qualitative interviews as part of a process evaluation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   9 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483493


Contacts
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Contact: Charlotte Hall, PhD 0115 8232438 charlotte.hall@nottingham.ac.uk
Contact: Emina Hadziosmanovic, PhD 07913651916 emina.hadziosmanvic@nottingham.ac.uk

Sponsors and Collaborators
Nottinghamshire Healthcare NHS Trust
University College, London
Karolinska Institutet
NIHR MindTech MedTech Co-operative
Great Ormond Street Hospital for Children NHS Foundation Trust
University of Nottingham
Investigators
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Principal Investigator: Chris Hollis, MD, PhD University of Nottingham

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nottinghamshire Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT03483493     History of Changes
Other Study ID Numbers: Hollis201117
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nottinghamshire Healthcare NHS Trust:
Tic disorders
Tourette Syndrome
Online delivered therapy

Additional relevant MeSH terms:
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Syndrome
Tourette Syndrome
Tic Disorders
Tics
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms