Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette's Disorder (NCT03916055) | Clinical Trial Compass
CompletedNot Applicable
Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette's Disorder
Sweden221 participantsStarted 2019-04-26
Plain-language 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.
Who can participate
Age range9 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Yale Global Tic Severity Scale (YGTSS) Total Tic Severity Score (TTSS)
. 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.