Clinical trial NCT03916055: Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette's Disorder
Official title: Clinical and Cost-effectiveness of Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette's Disorder: a Single-blind Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tourette's Disorder
Persistent (Chronic) Motor or Vocal Tic Disorder
Keywords: Tourette syndrome
Tourette
Tics
Behavior therapy
ERP
Internet
Self-help
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Uppsala University
First posted: 2019-04-16
Enrollment: 221
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind parallel-group randomised controlled superiority trial.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Aged 9 to 17 years. Confirmed by the caregiver and subsequently by the patient record system TakeCare.
2. 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.
3. 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.
4. 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.
5. 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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. A participant with a close relationship to the child/adolescent (e.g., sibling, cousin) has already been included in the trial.

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS)
timeFrame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Secondary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS) Impairment
timeFrame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: Clinical Global Impression - Severity (CGI-S)
timeFrame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: Clinical Global Impression - Improvement (CGI-I)
timeFrame: Week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: Children's Global Assessment Scale (CGAS)
timeFrame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: internet intervention Patient Adherence Scale (iiPAS)
timeFrame: Mid-treatment (5 weeks post-baseline); week 10.
measure: Therapist platform time
timeFrame: Week 10.
measure: Therapist telephone time
timeFrame: Week 10.
measure: Number of completed chapters in the internet treatment platform
timeFrame: Week 10.
measure: Number of logins to the internet treatment platform
timeFrame: Week 10; 12-month follow-up.
measure: Average time between logins to the internet treatment platform
timeFrame: Week 10.
measure: Average pages visited in the internet treatment platform
timeFrame: Week 10.
measure: Number of characters submitted in the internet treatment platform
timeFrame: Week 10.
measure: The Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life Scale (C&A-GTS-QOL)
timeFrame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: Short Mood and Feeling Questionnaire - child version (SMFQ) + additional suicide item
timeFrame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: Obsessive-compulsive inventory - child version (OCI-CV)
timeFrame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: Treatment credibility questionnaire
timeFrame: Mid-treatment (3 weeks post-baseline).
measure: Working alliance inventory - child and parent versions (WAI-C and WAI-P )
timeFrame: Mid-treatment (3 weeks post-baseline).
measure: Treatment satisfaction questionnaire
timeFrame: 3-month follow-up.
measure: KIDSCREEN-10
timeFrame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: Parent Tic Questionnaire (PTQ)
timeFrame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: Short Mood and Feeling Questionnaire - parent version (SMFQ)
timeFrame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
measure: Side effects questionnaire
timeFrame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up.
measure: Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
timeFrame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Child and Adolescent Psychiatry Research Center, BUP Klinisk forskningsenhet
Study officials:
affiliation: Department of Clinical Neuroscience (CNS), Karolinska Institutet
name: David Mataix-Cols, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andren P, Aspvall K, Fernandez de la Cruz L, Wiktor P, Romano S, Andersson E, Murphy T, Isomura K, Serlachius E, Mataix-Cols D. Therapist-guided and parent-guided internet-delivered behaviour therapy for paediatric Tourette's disorder: a pilot randomised controlled trial with long-term follow-up. BMJ Open. 2019 Feb 15;9(2):e024685. doi: 10.1136/bmjopen-2018-024685.
citation: Andren P, Holmsved M, Ringberg H, Wachtmeister V, Isomura K, Aspvall K, Lenhard F, Hall CL, Davies EB, Murphy T, Hollis C, Sampaio F, Feldman I, Bottai M, Serlachius E, Andersson E, Fernandez de la Cruz L, Mataix-Cols D. Therapist-Supported Internet-Delivered Exposure and Response Prevention for Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial. JAMA Netw Open. 2022 Aug 1;5(8):e2225614. doi: 10.1001/jamanetworkopen.2022.25614.
citation: Andren P, Fernandez de la Cruz L, Isomura K, Lenhard F, Hall CL, Davies EB, Murphy T, Hollis C, Sampaio F, Feldman I, Bottai M, Serlachius E, Andersson E, Mataix-Cols D. Efficacy and cost-effectiveness of therapist-guided internet-delivered behaviour therapy for children and adolescents with Tourette syndrome: study protocol for a single-blind randomised controlled trial. Trials. 2021 Sep 30;22(1):669. doi: 10.1186/s13063-021-05592-z.