Clinical trial NCT03483493: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tic Disorders
Tourette Syndrome
Keywords: Tic disorders
Tourette Syndrome
Online delivered therapy
Lead sponsor: Nottinghamshire Healthcare NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University College, London
name: Karolinska Institutet
name: NIHR MindTech MedTech Co-operative
name: Great Ormond Street Hospital for Children NHS Foundation Trust
name: University of Nottingham
First posted: 2018-03-30
Enrollment: 224
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessing change in tics in participants using the Yale Global Tic Severity Scale - Total Tic score
timeFrame: Baseline, 3, 6, 12 and 18 months
Secondary outcomes:
measure: Assessing change in tics in participants using the Parent Tic Questionnaire
timeFrame: Baseline, 5wks, 3mths, 6mths, 12mths & 18 months
measure: Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale.
timeFrame: 3, 6, 12 & 18 months
measure: Assessing change in tic impairment in participants using the Yale Global Tic Severity Scale Impairment Scale (assessing change)
timeFrame: Baseline, 3, 6, 12 & 18 months
measure: Assessing change in global functioning in participants using the Children's Global Assessment Scale
timeFrame: Baseline, 3, 6, 12 & 18 months
measure: Assessing change in general functioning in participants using the Strengths and Difficulties Questionnaire
timeFrame: Baseline, 3, 6, 12 & 18 months
measure: Assessing change in mood in participants using the Mood and Feelings Questionnaire
timeFrame: Baseline, 1, 3, 6, 12 & 18 months
measure: Assessing change in anxiety in participants using the Spence Child Anxiety Scale
timeFrame: Baseline, 3, 6, 12 & 18 months
measure: Assessing change in quality of life in participants using the Child Health Utility 9D
timeFrame: Baseline, 3, 6,12,18 months
measure: Assessing change in tic-related quality of life in participants using the Child and Adolescent Gilles de la Tourette Syndrome
timeFrame: Baseline, 3, 6, 12 & 18 months
measure: Assessing participants change in use of services using the Modified Client Service Receipt Inventory
timeFrame: Baseline, 3, 6, 12 & 18 months
measure: Assessing change in side effects in participants using the Adverse events/side effects
timeFrame: Baseline, 1, 3, 6, 12 & 18 months
measure: Assessing participants perception of treatment credibility using a specifically created 'treatment credibility' questionnaire
timeFrame: 3 weeks
measure: Assessing participants perception of treatment satisfaction using a specifically created 'treatment satisfaction' questionnaire
timeFrame: 3 months
measure: Assessing participants perception of their need for further treatment using a specifically created 'Need for further treatment' questionnaire
timeFrame: 3 months
measure: Assessing participants change of use of other medication/interventions using a specifically created 'Concomitant interventions' questionnaire
timeFrame: Baseline, 3, 6, 12 & 18 months
measure: Describing sample characteristics using Development and Wellbeing Assessment (DAWBA) at screening/baseline
timeFrame: Screening/Baseline
measure: Determining presence of an intellectual disability at screening/baseline using the Child and Adolescent Intellectual Disability Screening Questionnaire (CAIDS-Q)
timeFrame: Screening/Baseline
measure: Understanding the characteristics of the sample a specifically created demographics questionnaire at screening/baseline
timeFrame: Screening/Baseline
measure: Determining the for presence of Autism Spectrum Disorder using the Social Communication Questionnaire (SCQ) at screening/baseline
timeFrame: Screening/Baseline
measure: Assessing Premonitory urges for tics using the Premonitory Urge for Tics Scale (PUTS) at screening/baseline
timeFrame: Screening/Baseline
measure: Assessing ADHD symptoms using the Swanson, Nolan, and Pelham Rating Scale (SNAP-IV) at screening/baseline
timeFrame: Screening/Baseline
Other outcomes:
measure: To assess the process evaluation of the interventions qualitative interviews will be conducted
timeFrame: 3months
Locations:
city: Nottingham
country: United Kingdom
facility: Nottinghamshire Healthcare NHS Foundation Trust
Study officials:
affiliation: University of Nottingham
name: Chris Hollis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. 2023 Dec;54(6):1499-1509. doi: 10.1007/s10578-022-01348-1. Epub 2022 Apr 13.
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.
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.
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.