Tourette Syndrome Clinical Trial
Official title:
Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders
Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population. Studies have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive therapy for reducing tics in children and adults. Although CBIT is now recommended as a first-line intervention for tic disorders, many patients do not have access to CBIT, in part due to a lack of trained therapists. Currently, the only option available for training therapists in CBIT is an intensive, two day, in-person behavior therapy training institute (BTTI). This study will compare the traditional in-person training approach to a recently developed online, self-paced CBIT therapist training program called CBIT-Trainer with regard to (1) therapists' ability to accurately administer CBIT and (2) change in the severity of patients' tic symptoms after being treated by a CBIT-trained therapist.
Tic disorders are a class of childhood-onset neuropsychiatric disorders that occur in 1-3% of the population and often cause significant impairment in physical, social, academic, and interpersonal functioning and reduced quality of life. There is currently no cure for tic disorders, however large-scale randomized controlled trials have shown that a non-drug treatment known as Comprehensive Behavioral Intervention for Tics (CBIT) is more effective than supportive psychotherapy for reducing tics in both children and adults. Although CBIT is now recommended as a first-line intervention for tic disorders, many patients do not have access to CBIT, in part due to a lack of trained therapists. Given the need and desire for CBIT among individuals with tic disorders, high demand for therapist trainings, and the lack of therapists adequately trained in CBIT, there is a clear need for innovative ways to train more providers in this evidence-based treatment. To address this gap, the investigators recently developed an innovative online program for training therapists to deliver CBIT (called CBIT-Trainer). This study will test CBIT-Trainer against an intensive in-person therapist training program in a randomized controlled trial. This study will accomplish four aims: (1) to compare CBIT-Trainer to traditional in-person training on therapists' ability to administer CBIT with fidelity, (2) to compare CBIT-Trainer to in-person training on patient outcomes when patients are treated by a CBIT-trained therapist, (3) to identify therapist factors that might improve (or limit) adoption and use of CBIT-Trainer, and (4) to identify therapist factors likely to influence continued use of CBIT after training. These aims will be tested using an effectiveness-implementation hybrid randomized controlled trial comparing CBIT-Trainer (online therapist training) to the Tourette Association of America's Behavior Therapy Training Institute (in-person therapist training), which is the current gold-standard for training CBIT therapists. Therapist-patient dyads will be recruited to participate. The primary therapist outcome will be therapists' skill in delivering CBIT in a standardized role-play, which will be assessed at post-training (Week 0), after administering CBIT with a patient (Week 10), and at 6-month follow-up (Week 24). The primary patient outcome will be overall clinical improvement, which will be assessed at pre-treatment (Week 0), post-treatment (Week 10), and 6-month follow up (Week 24). Secondary therapist outcomes that will be assessed include changes in knowledge of tic disorders and CBIT; changes in comfort and self-efficacy in delivering CBIT; adherence to the CBIT protocol when treating a patient with tics; attitudes toward evidence-based practice and CBIT; and therapists' ratings of the acceptability, appropriateness, and feasibility of the training. Secondary patient outcomes that will be assessed include changes in motor and/or vocal tic severity; changes in overall psychological/behavioral, physical, and social functioning; and satisfaction with the treatment received. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04851678 -
Longitudinal Impact of Stressors in Adults With Tourette Syndrome
|
||
Completed |
NCT02605902 -
Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders
|
N/A | |
Completed |
NCT04007913 -
Incorporating teleCBIT Into a Hospital-Based Tic Program
|
N/A | |
Completed |
NCT02900144 -
Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)
|
N/A | |
Completed |
NCT02216474 -
Brain Stimulation in Movement Disorders
|
N/A | |
Completed |
NCT02256475 -
Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome
|
Phase 1 | |
Completed |
NCT01329198 -
Brain Stimulation for the Treatment of Tourette Syndrome
|
N/A | |
Terminated |
NCT00952601 -
Pilot Study of the Modified Atkins Diet for Tourette Syndrome
|
Phase 1 | |
Enrolling by invitation |
NCT00355927 -
Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.
|
N/A | |
Completed |
NCT00206323 -
A Randomized, Placebo-controlled, Tourette Syndrome Study.
|
Phase 3 | |
Completed |
NCT00004376 -
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder
|
Phase 3 | |
Completed |
NCT04498364 -
Extinction Learning in Adults With Tourette Syndrome
|
N/A | |
Completed |
NCT00755339 -
Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome
|
||
Completed |
NCT03325010 -
Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome
|
Phase 2 | |
Not yet recruiting |
NCT06081348 -
Sertraline vs. Placebo in the Treatment of Anxiety in Children and AdoLescents With NeurodevelopMental Disorders
|
Phase 2 | |
Completed |
NCT01719523 -
Open-Trial of EPI-743 for Adults With Tourette Syndrome
|
Phase 1 | |
Completed |
NCT01702077 -
Neurofeedback for Tourette Syndrome
|
N/A | |
Completed |
NCT00231985 -
Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder
|
Phase 2 | |
Completed |
NCT00206336 -
An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.
|
Phase 3 | |
Terminated |
NCT03732534 -
Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome
|
Phase 2 |