Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
| Uppsala University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure and response prevention (ERP) | Experimental | Therapist-guided and parent-guided internet-delivered exposure and response prevention (ERP) |
|
| Education on tics | Active Comparator | Therapist-guided and parent-guided internet-delivered education on tics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposure and response prevention (ERP) | Behavioral | 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. |
| 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. |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Mataix-Cols, PhD | Department of Clinical Neuroscience (CNS), Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Child and Adolescent Psychiatry Research Center, BUP Klinisk forskningsenhet | Stockholm | 113 30 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30772854 | Background | 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. | |
| 38700867 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D013981 | Tic Disorders |
| D020323 | Tics |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Single-blind parallel-group randomised controlled superiority trial.
Not provided
Not provided
Assessors conducting post- and follow-up assessments will be blind to treatment allocation, for the full duration of the trial. At each follow-up assessment, participants will be reminded by their assessor to not reveal their arm allocation. To measure blinding integrity, all assessors will record whether the participating families inadvertently reveal their group allocation, and subsequently guess each participant's treatment allocation at each assessment point, and motivate their choice. If the treatment allocation is accidently revealed, that very part will be cut out of the video recording, and a new blind assessor will watch the video and conduct the assessment that will be used in the trial. Subsequent assessments for that participant will then be conducted by a different assessor (than the first one; blind to treatment allocation), where possible. The blinding will be broken after the trial's final participant has finished her/his 3-month follow-up assessment (primary endpoint).
|
|
| Education on tics | Behavioral | 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. |
|
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. |
| Andren 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. |
| 35969401 | Derived | 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. |
| 34593015 | Derived | 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. |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |