Online Remote Behavioural Intervention for Tics (ORBIT)

NCT03483493 | Completed DMC

• 1 other identifier: Hollis201117
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

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.

Conditions

Tic Disorders; Tourette Syndrome

Keywords

Tic disorders; Tourette Syndrome; Online delivered therapy

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline, 3, 6, 12 and 18 months

Secondary Outcomes (21)

• Assessing change in tics in participants using the Parent Tic Questionnaire

  Baseline, 5wks, 3mths, 6mths, 12mths & 18 months

• Assessing change in symptom severity/improvement in participants using the Clinical Global Impressions Scale.

  3, 6, 12 & 18 months

• Assessing change in tic impairment in participants using the Yale Global Tic Severity Scale Impairment Scale (assessing change)

  Baseline, 3, 6, 12 & 18 months

• Assessing change in global functioning in participants using the Children's Global Assessment Scale

  Baseline, 3, 6, 12 & 18 months

• Assessing change in general functioning in participants using the Strengths and Difficulties Questionnaire

  Baseline, 3, 6, 12 & 18 months

Other Outcomes (1)

• To assess the process evaluation of the interventions qualitative interviews will be conducted

  3months

Study Arms (2)

Exposure Response Prevention for tics

EXPERIMENTAL

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

Behavioral: Exposure Response Prevention for tics

Active Control (Psychoeducation)

ACTIVE COMPARATOR

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

Other: Psychoeducation for tics

Interventions

Exposure Response Prevention for tics BEHAVIORAL

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'.

Exposure Response Prevention for tics

Psychoeducation for tics OTHER

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.

Active Control (Psychoeducation)

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nottinghamshire Healthcare NHS Trust: lead
• University College, London: collaborator
• Karolinska Institutet: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• University of Nottingham: collaborator

Study Sites (1)

Nottinghamshire Healthcare NHS Foundation Trust

Nottingham, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 34480868 RESULT

• Hall CL, Le Novere M, Murphy T, McNally E, Hollis C, Hunter R. Healthcare utilisation and costs associated with poor access to diagnosis and treatment for children and young people with tic disorders. BMJ Ment Health. 2024 Nov 7;27(1):e301241. doi: 10.1136/bmjment-2024-301241.

  PMID: 39515845 DERIVED

• Hollis C, Hall CL, Khan K, Le Novere M, Marston L, Jones R, Hunter R, Brown BJ, Sanderson C, Andren P, Bennett SD, Chamberlain LR, Davies EB, Evans A, Kouzoupi N, McKenzie C, Heyman I, Kilgariff J, Glazebrook C, Mataix-Cols D, Serlachius E, Murray E, Murphy T. Online remote behavioural intervention for tics in 9- to 17-year-olds: the ORBIT RCT with embedded process and economic evaluation. Health Technol Assess. 2023 Oct;27(18):1-120. doi: 10.3310/CPMS3211.

  PMID: 37924247 DERIVED

• Hollis C, Hall CL, Khan K, Jones R, Marston L, Le Novere M, Hunter R, Andren P, Bennett SD, Brown BJ, Chamberlain LR, Davies EB, Evans A, Kouzoupi N, McKenzie C, Sanderson C, Heyman I, Kilgariff J, Glazebrook C, Mataix-Cols D, Serlachius E, Murray E, Murphy T. Long-term clinical and cost-effectiveness of a therapist-supported online remote behavioural intervention for tics in children and adolescents: extended 12- and 18-month follow-up of a single-blind randomised controlled trial. J Child Psychol Psychiatry. 2023 Jun;64(6):941-951. doi: 10.1111/jcpp.13756. Epub 2023 Jan 17.

  PMID: 36649686 DERIVED

• 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.

  PMID: 35416566 DERIVED

• 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.

  PMID: 33298127 DERIVED

• 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.

  PMID: 31898510 DERIVED

• 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.

  PMID: 30610027 DERIVED

MeSH Terms

Conditions

Tic Disorders; Tourette Syndrome

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Basal Ganglia Diseases; Brain Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Chris Hollis, MD, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 30, 2018
• Study Start: May 7, 2018
• Primary Completion: February 18, 2020
• Study Completion: April 12, 2021
• Last Updated: September 9, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available beginning 3 months and ending 5 years after the specified trial outcome paper(s) is/are published.

Locations

GB (1)