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

NCT03916055 | Completed DMC

• 1 other identifier: 2018/1788-31/2
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette's Disorder; Persistent (Chronic) Motor or Vocal Tic Disorder

Keywords

Tourette syndrome; Tourette; Tics; Behavior therapy; ERP; Internet; Self-help

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (23)

• Yale Global Tic Severity Scale (YGTSS) Impairment

  Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.

• Clinical Global Impression - Severity (CGI-S)

  Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.

• Clinical Global Impression - Improvement (CGI-I)

  Week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.

• Children's Global Assessment Scale (CGAS)

  Baseline; week 10; 3-month follow-up; 6-month follow-up; 12-month follow-up.

• internet intervention Patient Adherence Scale (iiPAS)

  Mid-treatment (5 weeks post-baseline); week 10.

Study Arms (2)

Exposure and response prevention (ERP)

EXPERIMENTAL

Therapist-guided and parent-guided internet-delivered exposure and response prevention (ERP)

Behavioral: Exposure and response prevention (ERP)

Education on tics

ACTIVE COMPARATOR

Therapist-guided and parent-guided internet-delivered education on tics

Behavioral: Education on tics

Interventions

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.

Also known as: BIP TIC

Exposure and response prevention (ERP)

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.

Education on tics

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Aged 9 to 17 years. Confirmed by the caregiver and subsequently by the patient record system TakeCare.

You may not qualify if:

• A participant with a close relationship to the child/adolescent (e.g., sibling, cousin) has already been included in the trial.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Uppsala University: collaborator

Study Sites (1)

Child and Adolescent Psychiatry Research Center, BUP Klinisk forskningsenhet

Stockholm, 113 30, Sweden

Location

Related Publications (4)

• 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.

  PMID: 30772854 BACKGROUND

• 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.

  PMID: 38700867 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.

  PMID: 35969401 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.

  PMID: 34593015 DERIVED

MeSH Terms

Conditions

Tourette Syndrome; Bronchiolitis Obliterans Syndrome; Tic Disorders; Tics

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Mataix-Cols, PhD

  Department of Clinical Neuroscience (CNS), Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single-blind parallel-group randomised controlled superiority trial.

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 16, 2019
• Study Start: April 26, 2019
• Primary Completion: September 20, 2021
• Study Completion: June 29, 2022
• Last Updated: August 23, 2022

Record last verified: 2022-08

Locations

SE (1)