Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette's Disorder

Study Overview
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Brief Summary
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The purpose of this trial is to evaluate the clinical efficacy, 12-month durability, and cost-effectiveness of BIP TIC - a therapist-guided and parent-guided internet-delivered behavioural intervention for children and adolescents with Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder.

Detailed Description
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Primary objective: To determine the clinical efficacy of BIP TIC (Andrén et al., 2019; a therapist-guided and parent-guided, internet-delivered behavioural intervention for Tourette's Disorder (TD) and Persistent (Chronic) Motor or Vocal Tic Disorder (PTD), for reducing tic severity (as measured by the primary outcome variable Yale Global Tic Severity Scale [YGTSS] Total Tic Severity Score [TTSS]) in children and adolescents with TD/PTD, compared with a control intervention (therapist-guided and parent-guided internet-delivered education on tics). Secondary objectives: To establish the 12-month durability of the treatment effects, and to assess the cost-effectiveness of BIP TIC, compared with therapist-guided and parent-guided internet-delivered education on tics, from a societal perspective. Type of trial: Single-blind parallel-group randomised controlled superiority trial. Trial design and methods: All potential participants are initially screened via the telephone, or in some cases at the clinic. This is followed by an inclusion assessment conducted either at the clinic or via the videoconference software Zoom. Participants who are eligible and have consented will be randomised into one of two trial arms. In the experimental arm, participants receive 10 weeks of therapist-guided and parent-guided internet-delivered exposure and response prevention (ERP). In the control arm, participants receive 10 weeks of therapist-guided and parent-guided internet-delivered education on tics. Participants will complete outcome measures at baseline, mid-treatment (3 and 5 weeks post-baseline), post-treatment (10-weeks post-baseline) and 3, 6 and 12 months post-treatment. To allow for holidays or periods of sick leave, it is possible to extend the duration of the treatment from 10 to a maximum of 12 weeks (of which only 10 weeks will include therapist support). In these cases, the listed time frames in the Outcome Measures section will be extended with the equivalent number of weeks. The primary outcome variable is the Total Tic Severity Score (TTSS) of the Yale Global Tic Severity Scale (YGTSS), and the primary endpoint is the follow-up 3-months post-treatment. For secondary outcomes, see section below. Follow-up assessments will be conducted at the clinic or via Zoom videoconference software, in both cases complemented with online questionnaires. Planned trial sites: All assessments and delivery of treatment will be administrated from a single site in Stockholm, the Child and Adolescent Psychiatry Research Center. Several collaborating counties all across Sweden will assist on referring potential participants to the Stockholm site for inclusion in the trial. Sample: 220 participants. Statistical methodology and analysis: Data will be analysed using a pre-specified intention-to-treat statistical analysis plan.

Official Title
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Clinical and Cost-effectiveness of Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette's Disorder: a Single-blind Randomised Controlled Trial

Conditions
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Tourette's Disorder, Persistent (Chronic) Motor or Vocal Tic Disorder

Intervention / Treatment
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* Behavioral: Exposure and response prevention (ERP)
* Behavioral: Education on tics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 9 to 17 years. Confirmed by the caregiver and subsequently by the patient record system TakeCare. A diagnosis of Tourette's Disorder or Persistent (Chronic) Motor or Vocal Tic Disorder, based on the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5). Confirmed by the assessor at the face-to-face or videoconference inclusion assessment. A Total Tic Severity Score (TTSS) of >15 (or >10 if only motor or vocal tics, but not both, have been present the last week) on the YGTSS. Confirmed by the assessor at the face-to-face or videoconference inclusion assessment. A minimum of one available caregiver (parent) to support the child/adolescent throughout the treatment. Confirmed by the caregiver at the telephone screening or/and face-to-face or videoconference inclusion assessment. Regular access to a desktop or laptop computer connected to the internet, with the ability to receive e-mails, as well as a mobile phone to receive SMS (one of each is enough per family). Confirmed by the caregiver at the telephone screening or/and face-to-face or videoconference inclusion assessment. Exclusion Criteria: Previous behaviour therapy for tics, for a minimum of eight sessions with a qualified therapist within the 12 months prior to assessment. Confirmed by the caregiver at the telephone screening or/and face-to-face or videoconference inclusion assessment. Simultaneous psychological treatment for Tourette's Disorder or Persistent (Chronic) Motor or Vocal Tic Disorder. Confirmed by the caregiver at the telephone screening or/and face-to-face or videoconference inclusion assessment. Initiation or adjustment of any psychotropic medication for Tourette's Disorder or Persistent (Chronic) Motor or Vocal Tic Disorder within the eight weeks prior to assessment. Confirmed by the caregiver at the telephone screening or/and face-to-face or videoconference inclusion assessment. A diagnosis of organic brain disorder, intellectual disability, autism spectrum disorder, psychosis, bipolar disorder, anorexia nervosa, or alcohol/substance dependence. Confirmed by the assessor at the telephone screening or/and face-to-face or videoconference inclusion assessment, with help of information from the caregiver and the child/adolescent, and the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) interview. Immediate risk to self or others, requiring urgent medical attention, such as suicidality, or self-injurious tics. Confirmed by the assessor at the telephone screening or/and face-to-face or videoconference inclusion assessment. Child or caregiver (parent) not able to read and communicate in Swedish. Confirmed by the caregiver or assessor at the telephone screening or/and face-to-face or videoconference inclusion assessment. A participant with a close relationship to the child/adolescent (e.g., sibling, cousin) has already been included in the trial.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind parallel-group randomised controlled superiority trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exposure and response prevention (ERP)<br>Therapist-guided and parent-guided internet-delivered exposure and response prevention (ERP) | Behavioral: Exposure and response prevention (ERP)<br>* The intervention consists of 10 modules/chapters for children/adolescents, delivered over 10. Each of the 10 modules includes age-appropriate texts, animations and exercises. The intervention is primarily based on ERP techniques. During the treatment, participants are instructed to practice suppressing their tics, this is known as 'response prevention'. Then, with the help of their caregiver/parent, the participant is instructed to provoke premonitory urges (a sensation usually felt before a tic is expressed), while still suppressing tics, which is known as 'exposure'. The parent is provided with her/his own separate login to the internet platform, which consists of 10 separate modules/chapters. The parent intervention consists mainly of information regarding parent coping strategies, social support and functional analysis relating to tics. Both the child/adolescent and the parent have individual access to the same therapist.<br>* Other names: BIP TIC;|
| Active Comparator: Education on tics<br>Therapist-guided and parent-guided internet-delivered education on tics | Behavioral: Education on tics<br>* The active comparator is designed to match the experimental intervention in all aspects except for the module content (same platform, same treatment length, same therapist support etc.). The intervention consists mainly of psychoeducational information about TD/PTD and common comorbid conditions, and reviews the definition of tics, natural history, common presentations, prevalence, aetiology, risks and protective factors, strategies for describing tics to other people, among others. Problem-solving and development of expertise in tic disorders is emphasised. The intervention does not include any information on ERP or functional analysis and interventions. As in the experimental intervention, the parent is provided with her/his own separate login to the internet platform. The parent intervention consists mainly of information regarding parent coping strategies and social support. Both the child and the parent have individual access to the same therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS) | Change in tic severity (motor and/or vocal tics) (range 0-50 points) from week 0 (baseline) to week 10 (post-treatment), 3-month follow-up (after post-treatment), 6-month follow-up and 12-month follow-up. The primary endpoint is the 3-month follow-up. The TTSS can also be divided into separate severity scores for motor tics (range 0-25 points) and vocal tics (range 0-25 points). When summed, these two scores comprise the TTSS (range 0-50 points). A higher value represents a greater tic severity. Clinician-rated, semi-structured interview. | Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale Global Tic Severity Scale (YGTSS) Impairment | Impairment score (range 0-50 points) of the YGTSS. Used to assess tic specific impairment. Clinician-rated, semi-structured interview. | Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| Clinical Global Impression - Severity (CGI-S) | Used to provide an overall rating of the tic disorder severity. Clinician-rated. | Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| Clinical Global Impression - Improvement (CGI-I) | Used to assess global improvement. Clinician-rated. Treatment response in the trial is operationalised as scores of very much improved (1) or much improved (2) on the CGI-I. | Week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| Children's Global Assessment Scale (CGAS) | Used to assess global improvement. Clinician-rated. | Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| internet intervention Patient Adherence Scale (iiPAS) | Used to assess the child/adolescent's adherence to the internet-delivered treatment. Clinician-rated. | Mid-treatment (5 weeks post-baseline); week 10. | 
| Therapist platform time | Therapist platform time is automatically logged in the internet treatment platform. Separate data for children and parents. | Week 10. | 
| Therapist telephone time | Therapist telephone time is manually logged in a spreadsheet throughout the trial. Separate data for children and parents. | Week 10. | 
| Number of completed chapters in the internet treatment platform | Number of completed chapters is automatically logged in the internet treatment platform. Separate data for children and parents. | Week 10. | 
| Number of logins to the internet treatment platform | Number of logins is automatically logged in the internet treatment platform. Separate data for children and parents. | Week 10; 12-month follow-up. | 
| Average time between logins to the internet treatment platform | Average time between logins is automatically logged in the internet treatment platform. Separate data for children and parents. | Week 10. | 
| Average pages visited in the internet treatment platform | Average pages visited in the internet treatment platform. Separate data for children and parents. | Week 10. | 
| Number of characters submitted in the internet treatment platform | Number of characters submitted in the internet treatment platform. Separate data for children and parents. | Week 10. | 
| The Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life Scale (C&A-GTS-QOL) | Used to assess disease-specific health-related quality of life. Two different versions will be used, one for participants aged 9-12, and one for participants aged 13-17. Child/adolescent-reported. | Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| Short Mood and Feeling Questionnaire - child version (SMFQ) + additional suicide item | Used to assess depressive symptoms and suicidal ideation. Child/adolescent-reported. | Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| Obsessive-compulsive inventory - child version (OCI-CV) | Used to assess obsessive-compulsive symptoms. Child/adolescent-reported. | Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| Treatment credibility questionnaire | Questionnaire developed by the research team. Used to assess treatment credibility. Separate versions for the child/adolescent and the parent are used. | Mid-treatment (3 weeks post-baseline). | 
| Working alliance inventory - child and parent versions (WAI-C and WAI-P ) | Used to assess the child/adolescent/parent's perceived working alliance with their therapist. Separate versions for the child/adolescent and the parent are used. | Mid-treatment (3 weeks post-baseline). | 
| Treatment satisfaction questionnaire | Questionnaire developed by the research team. Used to assess treatment satisfaction. Separate versions for the child/adolescent and the parent are used. | 3-month follow-up. | 
| KIDSCREEN-10 | Used to assess quality of life, with the intention to transform this data into quality adjusted lifetime years (QALYs). Separate versions for the child/adolescent and the parent are used. | Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| Parent Tic Questionnaire (PTQ) | Used to assess tic severity. Parent-reported. | Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| Short Mood and Feeling Questionnaire - parent version (SMFQ) | Used to assess depressive symptoms. Parent-reported. | Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 
| Side effects questionnaire | Used to assess side effects/adverse events for the child/adolescent. Parent-reported. | Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up. | 
| Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P) | Used to assess healthcare and societal resource use. Parent-reported. | Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERP, Tourette syndrome, Tourette, Tics, Behavior therapy, Internet, Self-help