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

Primary Purpose

Tic Disorders, Tourette Syndrome

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Exposure Response Prevention for tics
Psychoeducation for tics
Sponsored by
Nottinghamshire Healthcare NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tic Disorders focused on measuring Tic disorders, Tourette Syndrome, Online delivered therapy

Eligibility Criteria

9 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nottinghamshire Healthcare NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exposure Response Prevention for tics

Active Control (Psychoeducation)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Assessing change in tics in participants using the Parent Tic Questionnaire
Self administered questionnaire to collect the number, frequency and intensity of 14 common motor and 14 common vocal tics
Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale.
Clinician determined measure that summarises the patient's history, symptoms, behaviours and psychosocial circumstances
Assessing change in tic impairment in participants using the Yale Global Tic Severity Scale Impairment Scale (assessing change)
This forms part of the YGTSS but focuses on distress and impairment experienced in the individuals life
Assessing change in global functioning in participants using the Children's Global Assessment Scale
A measure of psychiatric disturbance integrating psychological, social and academic functioning
Assessing change in general functioning in participants using the Strengths and Difficulties Questionnaire
Self-report, parent completed questionnaire measuring behavioural and emotional difficulties in children. The baseline SDQ is completed as part of a screening tool "DAWBA".
Assessing change in mood in participants using the Mood and Feelings Questionnaire
Child completed, self-report questionnaire collecting information on depressive symptoms
Assessing change in anxiety in participants using the Spence Child Anxiety Scale
Self-report child completed questionnaire evaluating symptoms of separation anxiety, social phobia, obsessive-compulsive disorder, pain, agoraphobia, generalised anxiety and fear of physical injury
Assessing change in quality of life in participants using the Child Health Utility 9D
Self-report parent and child completed quality of life measure
Assessing change in tic-related quality of life in participants using the Child and Adolescent Gilles de la Tourette Syndrome
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
Assessing participants change in use of services using the Modified Client Service Receipt Inventory
A questionnaire to collect information on services received, service related issues, school attendance and family income
Assessing change in side effects in participants using the Adverse events/side effects
A 17 item scale of common side effects
Assessing participants perception of treatment credibility using a specifically created 'treatment credibility' questionnaire
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
Assessing participants perception of treatment satisfaction using a specifically created 'treatment satisfaction' questionnaire
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
Assessing participants perception of their need for further treatment using a specifically created 'Need for further treatment' questionnaire
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
Assessing participants change of use of other medication/interventions using a specifically created 'Concomitant interventions' questionnaire
Assessment of any other treatment or interventions the child or young person is accessing during the study
Describing sample characteristics using Development and Wellbeing Assessment (DAWBA) at 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.
Determining presence of an intellectual disability at screening/baseline using the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q)
A 7-item questionnaire to determine the presence of intellectual disability at screening/baseline, completed by the parent/
Understanding the characteristics of the sample a specifically created demographics questionnaire at 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.
Determining the for presence of Autism Spectrum Disorder using the Social Communication Questionnaire (SCQ) at screening/baseline
A 40 item, parent-report questionnaire asking about characteristic autistic behaviour at the age of 4 to 5 years and currently.
Assessing Premonitory urges for tics using the Premonitory Urge for Tics Scale (PUTS) at screening/baseline
A self-report instrument specifically designed to measure the current frequency of different types of premonitory urges in patients with tic disorders
Assessing ADHD symptoms using the Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at 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.

Full Information

First Posted
March 12, 2018
Last Updated
September 8, 2021
Sponsor
Nottinghamshire Healthcare NHS Trust
Collaborators
University College, London, Karolinska Institutet, NIHR MindTech MedTech Co-operative, Great Ormond Street Hospital for Children NHS Foundation Trust, University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT03483493
Brief Title
Online Remote Behavioural Intervention for Tics (ORBIT)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 7, 2018 (Actual)
Primary Completion Date
February 18, 2020 (Actual)
Study Completion Date
April 12, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottinghamshire Healthcare NHS Trust
Collaborators
University College, London, Karolinska Institutet, NIHR MindTech MedTech Co-operative, Great Ormond Street Hospital for Children NHS Foundation Trust, University of Nottingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tic Disorders, Tourette Syndrome
Keywords
Tic disorders, Tourette Syndrome, Online delivered therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exposure Response Prevention for tics
Arm Type
Experimental
Arm Description
10-weeks, online delivered, therapist supported exposure response prevention (ERP) therapy for tics
Arm Title
Active Control (Psychoeducation)
Arm Type
Active Comparator
Arm Description
10-weeks, online delivered, therapist supported psychoeducation for tics
Intervention Type
Behavioral
Intervention Name(s)
Exposure Response Prevention for tics
Intervention Description
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
Other
Intervention Name(s)
Psychoeducation for tics
Intervention Description
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 Measure Information:
Title
Assessing change in tics in participants using the Yale Global Tic Severity Scale - Total Tic score
Description
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
Time Frame
Baseline, 3, 6, 12 and 18 months
Secondary Outcome Measure Information:
Title
Assessing change in tics in participants using the Parent Tic Questionnaire
Description
Self administered questionnaire to collect the number, frequency and intensity of 14 common motor and 14 common vocal tics
Time Frame
Baseline, 5wks, 3mths, 6mths, 12mths & 18 months
Title
Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale.
Description
Clinician determined measure that summarises the patient's history, symptoms, behaviours and psychosocial circumstances
Time Frame
3, 6, 12 & 18 months
Title
Assessing change in tic impairment in participants using the Yale Global Tic Severity Scale Impairment Scale (assessing change)
Description
This forms part of the YGTSS but focuses on distress and impairment experienced in the individuals life
Time Frame
Baseline, 3, 6, 12 & 18 months
Title
Assessing change in global functioning in participants using the Children's Global Assessment Scale
Description
A measure of psychiatric disturbance integrating psychological, social and academic functioning
Time Frame
Baseline, 3, 6, 12 & 18 months
Title
Assessing change in general functioning in participants using the Strengths and Difficulties Questionnaire
Description
Self-report, parent completed questionnaire measuring behavioural and emotional difficulties in children. The baseline SDQ is completed as part of a screening tool "DAWBA".
Time Frame
Baseline, 3, 6, 12 & 18 months
Title
Assessing change in mood in participants using the Mood and Feelings Questionnaire
Description
Child completed, self-report questionnaire collecting information on depressive symptoms
Time Frame
Baseline, 1, 3, 6, 12 & 18 months
Title
Assessing change in anxiety in participants using the Spence Child Anxiety Scale
Description
Self-report child completed questionnaire evaluating symptoms of separation anxiety, social phobia, obsessive-compulsive disorder, pain, agoraphobia, generalised anxiety and fear of physical injury
Time Frame
Baseline, 3, 6, 12 & 18 months
Title
Assessing change in quality of life in participants using the Child Health Utility 9D
Description
Self-report parent and child completed quality of life measure
Time Frame
Baseline, 3, 6,12,18 months
Title
Assessing change in tic-related quality of life in participants using the Child and Adolescent Gilles de la Tourette Syndrome
Description
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
Time Frame
Baseline, 3, 6, 12 & 18 months
Title
Assessing participants change in use of services using the Modified Client Service Receipt Inventory
Description
A questionnaire to collect information on services received, service related issues, school attendance and family income
Time Frame
Baseline, 3, 6, 12 & 18 months
Title
Assessing change in side effects in participants using the Adverse events/side effects
Description
A 17 item scale of common side effects
Time Frame
Baseline, 1, 3, 6, 12 & 18 months
Title
Assessing participants perception of treatment credibility using a specifically created 'treatment credibility' questionnaire
Description
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
Time Frame
3 weeks
Title
Assessing participants perception of treatment satisfaction using a specifically created 'treatment satisfaction' questionnaire
Description
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
Time Frame
3 months
Title
Assessing participants perception of their need for further treatment using a specifically created 'Need for further treatment' questionnaire
Description
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
Time Frame
3 months
Title
Assessing participants change of use of other medication/interventions using a specifically created 'Concomitant interventions' questionnaire
Description
Assessment of any other treatment or interventions the child or young person is accessing during the study
Time Frame
Baseline, 3, 6, 12 & 18 months
Title
Describing sample characteristics using Development and Wellbeing Assessment (DAWBA) at screening/baseline
Description
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.
Time Frame
Screening/Baseline
Title
Determining presence of an intellectual disability at screening/baseline using the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q)
Description
A 7-item questionnaire to determine the presence of intellectual disability at screening/baseline, completed by the parent/
Time Frame
Screening/Baseline
Title
Understanding the characteristics of the sample a specifically created demographics questionnaire at screening/baseline
Description
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.
Time Frame
Screening/Baseline
Title
Determining the for presence of Autism Spectrum Disorder using the Social Communication Questionnaire (SCQ) at screening/baseline
Description
A 40 item, parent-report questionnaire asking about characteristic autistic behaviour at the age of 4 to 5 years and currently.
Time Frame
Screening/Baseline
Title
Assessing Premonitory urges for tics using the Premonitory Urge for Tics Scale (PUTS) at screening/baseline
Description
A self-report instrument specifically designed to measure the current frequency of different types of premonitory urges in patients with tic disorders
Time Frame
Screening/Baseline
Title
Assessing ADHD symptoms using the Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at screening/baseline
Description
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.
Time Frame
Screening/Baseline
Other Pre-specified Outcome Measures:
Title
To assess the process evaluation of the interventions qualitative interviews will be conducted
Description
A sub-sample of participants will be as asked to participate in qualitative interviews as part of a process evaluation.
Time Frame
3months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Hollis, MD, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottinghamshire Healthcare NHS Foundation Trust
City
Nottingham
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data are available for use by researchers with a sound research idea from priment@ucl.ac.uk
IPD Sharing Time Frame
Data will be made available beginning 3 months and ending 5 years after the specified trial outcome paper(s) is/are published.
Citations:
PubMed Identifier
34480868
Citation
Hollis C, Hall CL, Jones R, Marston L, Novere ML, Hunter R, Brown BJ, Sanderson C, Andren P, Bennett SD, Chamberlain LR, Davies EB, Evans A, Kouzoupi N, McKenzie C, Heyman I, Khan K, Kilgariff J, Glazebrook C, Mataix-Cols D, Murphy T, Serlachius E, Murray E. Therapist-supported online remote behavioural intervention for tics in children and adolescents in England (ORBIT): a multicentre, parallel group, single-blind, randomised controlled trial. Lancet Psychiatry. 2021 Oct;8(10):871-882. doi: 10.1016/S2215-0366(21)00235-2. Epub 2021 Sep 1. Erratum In: Lancet Psychiatry. 2022 Jan;9(1):e1. Lancet Psychiatry. 2022 Jun;9(6):e23.
Results Reference
result
PubMed Identifier
35416566
Citation
Hall CL, Marston L, Khan K, Brown BJ, Sanderson C, Andren P, Bennett S, Heyman I, Mataix-Cols D, Serlachius E, Hollis C, Murphy T. The COVID-19 pandemic and its impact on tic symptoms in children and young people: a prospective cohort study. Child Psychiatry Hum Dev. 2022 Apr 13:1-11. doi: 10.1007/s10578-022-01348-1. Online ahead of print.
Results Reference
derived
PubMed Identifier
33298127
Citation
Hall CL, Sanderson C, Brown BJ, Andren P, Bennett S, Chamberlain LR, Davies EB, Khan K, Kouzoupi N, Mataix-Cols D, McKenzie C, Murphy T, Townsend M, Hollis C, Murray E. Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people. Trials. 2020 Dec 9;21(1):1011. doi: 10.1186/s13063-020-04902-1.
Results Reference
derived
PubMed Identifier
31898510
Citation
Khan K, Hollis C, Hall CL, Davies EB, Mataix-Cols D, Andren P, Murphy T, Brown BJ, Murray E, Glazebrook C. Protocol for the Process Evaluation of the Online Remote Behavioural Intervention for Tics (ORBIT) randomized controlled trial for children and young people. Trials. 2020 Jan 2;21(1):6. doi: 10.1186/s13063-019-3974-3.
Results Reference
derived
PubMed Identifier
30610027
Citation
Hall CL, Davies EB, Andren P, Murphy T, Bennett S, Brown BJ, Brown S, Chamberlain L, Craven MP, Evans A, Glazebrook C, Heyman I, Hunter R, Jones R, Kilgariff J, Marston L, Mataix-Cols D, Murray E, Sanderson C, Serlachius E, Hollis C; ORBIT Trial team.. Investigating a therapist-guided, parent-assisted remote digital behavioural intervention for tics in children and adolescents-'Online Remote Behavioural Intervention for Tics' (ORBIT) trial: protocol of an internal pilot study and single-blind randomised controlled trial. BMJ Open. 2019 Jan 3;9(1):e027583. doi: 10.1136/bmjopen-2018-027583.
Results Reference
derived

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Online Remote Behavioural Intervention for Tics (ORBIT)

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