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

Not Applicable

Completed

• Conditions: Tourette's Disorder; Persistent (Chronic) Motor or Vocal Tic Disorder
• Interventions: Behavioral: Education on tics; Behavioral: Exposure and response prevention (ERP)

• Registration Number: NCT03916055
• Lead Sponsor: Karolinska Institutet

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.

Study Timeline

• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-16
• Study Start: 2019-04-26
• Primary Completion: 2021-09-20
• Study Completion: 2022-06-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-22
• Last Update Posted: 2022-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 221

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education on tics	Education on tics	Therapist-guided and parent-guided internet-delivered education on tics
Exposure and response prevention (ERP)	Exposure and response prevention (ERP)	Therapist-guided and parent-guided internet-delivered exposure and response prevention (ERP)

Primary Outcome Measures

Name	Time	Method
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS)	Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	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.

Secondary Outcome Measures

Name	Time	Method
Number of logins to the internet treatment platform	Week 10; 12-month follow-up.	Number of logins is automatically logged in the internet treatment platform. Separate data for children and parents.
Average pages visited in the internet treatment platform	Week 10.	Average pages visited in the internet treatment platform. Separate data for children and parents.
Short Mood and Feeling Questionnaire - child version (SMFQ) + additional suicide item	Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	Used to assess depressive symptoms and suicidal ideation. Child/adolescent-reported.
Obsessive-compulsive inventory - child version (OCI-CV)	Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	Used to assess obsessive-compulsive symptoms. Child/adolescent-reported.
Clinical Global Impression - Severity (CGI-S)	Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	Used to provide an overall rating of the tic disorder severity. Clinician-rated.
Therapist telephone time	Week 10.	Therapist telephone time is manually logged in a spreadsheet throughout the trial. Separate data for children and parents.
Average time between logins to the internet treatment platform	Week 10.	Average time between logins is automatically logged in the internet treatment platform. Separate data for children and parents.
Treatment credibility questionnaire	Mid-treatment (3 weeks post-baseline).	Questionnaire developed by the research team. Used to assess treatment credibility. Separate versions for the child/adolescent and the parent are used.
Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)	Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	Used to assess healthcare and societal resource use. Parent-reported.
Clinical Global Impression - Improvement (CGI-I)	Week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	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.
Therapist platform time	Week 10.	Therapist platform time is automatically logged in the internet treatment platform. Separate data for children and parents.
Parent Tic Questionnaire (PTQ)	Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	Used to assess tic severity. Parent-reported.
Short Mood and Feeling Questionnaire - parent version (SMFQ)	Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	Used to assess depressive symptoms. Parent-reported.
Side effects questionnaire	Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up.	Used to assess side effects/adverse events for the child/adolescent. Parent-reported.
Yale Global Tic Severity Scale (YGTSS) Impairment	Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	Impairment score (range 0-50 points) of the YGTSS. Used to assess tic specific impairment. Clinician-rated, semi-structured interview.
Children's Global Assessment Scale (CGAS)	Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	Used to assess global improvement. Clinician-rated.
internet intervention Patient Adherence Scale (iiPAS)	Mid-treatment (5 weeks post-baseline); week 10.	Used to assess the child/adolescent's adherence to the internet-delivered treatment. Clinician-rated.
Number of completed chapters in the internet treatment platform	Week 10.	Number of completed chapters is automatically logged in the internet treatment platform. Separate data for children and parents.
Number of characters submitted in the internet treatment platform	Week 10.	Number of characters submitted in the internet treatment platform. Separate data for children and parents.
The Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life Scale (C&A-GTS-QOL)	Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	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.
Working alliance inventory - child and parent versions (WAI-C and WAI-P )	Mid-treatment (3 weeks post-baseline).	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.
Treatment satisfaction questionnaire	3-month follow-up.	Questionnaire developed by the research team. Used to assess treatment satisfaction. Separate versions for the child/adolescent and the parent are used.
KIDSCREEN-10	Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.	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.

Trial Locations

Locations (1)

Child and Adolescent Psychiatry Research Center, BUP Klinisk forskningsenhet; 🇸🇪 Stockholm, Sweden