Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette's Disorder
Condition: Tourette's Disorder; Persistent (Chronic) Motor or Vocal Tic Disorder
MeSH terms: Tic Disorders; Tics; Tourette Syndrome
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Exposure and response prevention (ERP); Education on tics
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Other intervention name(s): BIP TIC
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-blind parallel-group randomised controlled superiority trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourette syndrome; Tourette; Tics; Behavior therapy; ERP; Internet; Self-help