Tourette's DisorderNCT03916055
Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette's Disorder
A study testing Exposure and response prevention (ERP) and Education on tics in people with Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Tourette's Disorder, Persistent (Chronic) Motor or Vocal Tic Disorder
- What is being tested?
- Exposure and response prevention (ERP) and Education on tics
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 221 participants
- Where
- 1 siteSweden
- Study dates
- 26 Apr 2019to 29 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Child and Adolescent Psychiatry Research Center, BUP Klinisk forskningsenhet
Stockholm, 113 30
About this study
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
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.
Read the 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.
- Being tested
- Exposure and response prevention (ERP), Education on tics
- Keywords
- Tourette syndrome, Tourette, Tics, Behavior therapy, ERP, Internet, Self-help
- Medical subject headings
- Tourette Syndrome, Bronchiolitis Obliterans Syndrome, Tic Disorders, Tics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure and response prevention (ERP)Behavioural
Also called BIP TIC
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.
Education on ticsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Exposure and response prevention (ERP) | Experimental | Therapist-guided and parent-guided internet-delivered exposure and response prevention (ERP) Receives: Behavioral: Exposure and response prevention (ERP) |
| Education on tics | Active comparator | Therapist-guided and parent-guided internet-delivered education on tics Receives: Behavioral: Education on tics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Secondary outcomes (23)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 10.
Therapist telephone time
Therapist telephone time is manually logged in a spreadsheet throughout the trial. Separate data for children and parents.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 10.
Average pages visited in the internet treatment platform
Average pages visited in the internet treatment platform. Separate data for children and parents.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start26 Apr 2019
- Primary completion20 Sep 2021
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Tourette's DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind parallel-group randomised controlled superiority trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Uppsala University
- Responsible party
- Principal investigator, David Mataix-Cols, Karolinska Institutet
- Investigators
- David Mataix-Cols, PhD, Principal investigator, Department of Clinical Neuroscience (CNS), Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916055
- Sponsor's protocol ID
- 2018/1788-31/2
- Status last verified
- Aug 2022
- First submitted
- 4 Apr 2019
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30772854Andren P, Sampaio F, Ringberg H, Wachtmeister V, Warnstrom M, Isomura K, Aspvall K, Lenhard F, Hall CL, Davies EB, Murphy T, Hollis C, Feldman I, Bottai M, Serlachius E, Andersson E, Fernandez de la Cruz L, Mataix-Cols D. Internet-Delivered Exposure and Response Prevention for Pediatric Tourette Syndrome: 12-Month Follow-Up of a Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e248468. doi: 10.1001/jamanetworkopen.2024.8468.
PubMed 38700867Andren 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.
PubMed 35969401Andren 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.
PubMed 34593015
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03916055
- Acronym / sponsor ID
- 2018/1788-31/2
- Keywords
- Tourette syndrome, Tourette, Tics, Behavior therapy, ERP, Internet, Self-help
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Uppsala University
- Study start
- 26 Apr 2019 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-blind parallel-group randomised controlled superiority trial.
| Arm | Type | Receives |
|---|---|---|
| Exposure and response prevention (ERP) | Experimental | Behavioral: Exposure and response prevention (ERP)Therapist-guided and parent-guided internet-delivered exposure and response prevention (ERP) |
| Education on tics | Active comparator | Behavioral: Education on ticsTherapist-guided and parent-guided internet-delivered education on tics |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure and response prevention (ERP)Also: BIP TICThe 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. | Behavioural | Exposure and response prevention (ERP) |
| Education on ticsThe 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. | Behavioural | Education on tics |
Primary outcome
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS)
Time frame: 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.
23 secondary outcomes
Yale Global Tic Severity Scale (YGTSS) Impairment
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Clinical Global Impression - Severity (CGI-S)
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Clinical Global Impression - Improvement (CGI-I)
Time frame: Week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Children's Global Assessment Scale (CGAS)
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
internet intervention Patient Adherence Scale (iiPAS)
Time frame: Mid-treatment (5 weeks post-baseline); week 10.
Therapist platform time
Time frame: Week 10.
Therapist telephone time
Time frame: Week 10.
Number of completed chapters in the internet treatment platform
Time frame: Week 10.
Number of logins to the internet treatment platform
Time frame: Week 10; 12-month follow-up.
Average time between logins to the internet treatment platform
Time frame: Week 10.
Average pages visited in the internet treatment platform
Time frame: Week 10.
Number of characters submitted in the internet treatment platform
Time frame: Week 10.
The Child and Adolescent Gilles de la Tourette Syndrome-Quality of Life Scale (C&A-GTS-QOL)
Time frame: 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
Time frame: 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)
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Treatment credibility questionnaire
Time frame: Mid-treatment (3 weeks post-baseline).
Working alliance inventory - child and parent versions (WAI-C and WAI-P )
Time frame: Mid-treatment (3 weeks post-baseline).
Treatment satisfaction questionnaire
Time frame: 3-month follow-up.
KIDSCREEN-10
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Parent Tic Questionnaire (PTQ)
Time frame: 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)
Time frame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Side effects questionnaire
Time frame: Baseline; mid-treatment (5 weeks post-baseline); week 10; 3-month follow-up.
Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Background: PubMed 30772854Andren 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.
- Derived from this study: PubMed 38700867Andren P, Sampaio F, Ringberg H, Wachtmeister V, Warnstrom M, Isomura K, Aspvall K, Lenhard F, Hall CL, Davies EB, Murphy T, Hollis C, Feldman I, Bottai M, Serlachius E, Andersson E, Fernandez de la Cruz L, Mataix-Cols D. Internet-Delivered Exposure and Response Prevention for Pediatric Tourette Syndrome: 12-Month Follow-Up of a Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e248468. doi: 10.1001/jamanetworkopen.2024.8468.
- Derived from this study: PubMed 35969401Andren 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.
- Derived from this study: PubMed 34593015Andren 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Mataix-Cols, PhD principal investigator
Department of Clinical Neuroscience (CNS), Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure and response prevention (ERP) and Education on tics in people with Tourette's Disorder and Persistent (Chronic) Motor or Vocal Tic Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS) (time frame: Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03916055, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.