Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tics
- Sponsor
- University of Utah
- Enrollment
- 234
- Locations
- 2
- Primary Endpoint
- Therapist scores on the CBIT Fidelity Checklist & Rating Scale at 6-month follow-up
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Mike Himle
Associate Professor
University of Utah
Eligibility Criteria
Inclusion Criteria
- •Have the equivalent of a Master's degree (or higher) in a mental/behavioral health, medical, or related discipline.
- •Professionally licensed or certified to practice in their area of speciality.
- •Attest that providing comprehensive behavioral intervention for tics (CBIT) to treat children and/or adults with tic disorders falls within their scope of practice according to state licensing laws and regulations in the therapist's jurisdiction.
- •Have never attended the Tourette Association of America's Behavior Therapy Training Institute or an equivalent focused on CBIT.
- •Have access to a secure personal computer with high-speed internet access.
- •Speaks fluent English.
- •Has identified, or is willing to try to identify, at least 1 child or adult patient with a tic disorder who meets the patient inclusion criteria and who might be willing to participate in the study as a member of the therapist-patient dyad, and for whom the therapist is licensed or certified to treat with CBIT according to state licensing laws and regulations in the therapist's jurisdiction.
- •Is willing to be randomly assigned to training condition.
- •Is willing, able, and has the necessary resources to travel to, and attend, one of several in-person training sites if assigned to the in-person training condition.
Exclusion Criteria
- •(1) Therapist is a first, second, or third degree biological relative, stepparent, or legal guardian of the study-matched patient.
- •Patient Inclusion Criteria:
- •7 years of age or older (with consenting adult for minors).
- •Self- or parent-reported diagnosis of a tic disorder (e.g., provisional tic disorder, persistent motor/vocal tic disorder, or Tourette's disorder) issued by a qualified professional.
- •Currently engages in at least one motor and/or vocal tic multiple times per day.
- •Patient (and consenting adult for minors) speaks fluent English.
- •Access to a private computer with high-speed internet access.
- •Patient Exclusion Criteria:
- •Patients will be excluded if the study team is unable to identify and enroll a patient-matched therapist who meets the therapist inclusion criteria.
- •Patient is a first, second, or third degree biological relative of the study-matched therapist or if the study-matched therapist is the patient's legal guardian.
Outcomes
Primary Outcomes
Therapist scores on the CBIT Fidelity Checklist & Rating Scale at 6-month follow-up
Time Frame: 24-26 weeks post-training
The CBIT Fidelity Checklist and Rating Scale measures therapists' accuracy in administering 12 core components of CBIT during a standardized role-play. Items are rated using a series of 5-point Likert-type ratings ranging from "poor" to "excellent." Item ratings are aggregated to provide an overall fidelity rating ranging from 0-48. Higher ratings indicate better performance.
Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-training
Time Frame: up to 2 weeks post-training
The CBIT Fidelity Checklist and Rating Scale measures therapists' accuracy in administering 12 core components of CBIT during a standardized role-play. Items are rated using a series of 5-point Likert-type ratings ranging from "poor" to "excellent." Item ratings are aggregated to provide an overall fidelity rating ranging from 0-48. Higher ratings indicate better performance.
Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-treatment
Time Frame: 10-12 weeks post-training
The CBIT Fidelity Checklist and Rating Scale measures therapists' accuracy in administering 12 core components of CBIT during a standardized role-play. Items are rated using a series of 5-point Likert-type ratings ranging from "poor" to "excellent." Item ratings are aggregated to provide an overall fidelity rating ranging from 0-48. Higher ratings indicate better performance.
Proportion of treatment responders at post-treatment on the Clinical Global Impression Improvement Scale (CGI-I)
Time Frame: 10-12 weeks from the start of treatment (post-treatment)
The CGI-I is a single-item clinical rating of symptom improvement relative to baseline. Ratings on the CGI-I range from 1 (very much improved) to 7 (very much worse). CGI-I ratings of 1 (very much improved) or 2 (much improved) indicate positive treatment response. Higher scores are related to worse treatment response.
Proportion of treatment responders at follow-up on the Clinical Global Impression Improvement Scale (CGI-I)
Time Frame: 24-26 weeks from the start of treatment (6-month follow-up)
The CGI-I is a single-item clinical rating of symptom improvement relative to baseline. Ratings on the CGI-I range from 1 (very much improved) to 7 (very much worse). CGI-I ratings of 1 (very much improved) or 2 (much improved) indicate positive treatment response. Higher scores are related to worse treatment response.
Patient changes in overall symptom severity on the Clinical Global Impression Severity Scale (CGI-S)
Time Frame: Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up)
The CGI-S is a single-item clinical rating of the participant's illness at the time of the assessment. Ratings on the CGI-S range from 1 (slight psychiatric illness) to 7 (extremely severe psychiatric illness). Higher scores indicate greater symptom severity.
Secondary Outcomes
- Patient changes in tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) Total Tic Score(Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up))
- Therapist change scores on the Tic Disorder & CBIT Knowledge Test(Up to 2 weeks pre-training and up to 2 weeks post training)
- Therapist changes in self-efficacy to treat tic disorders as measured by the Therapist Self-Assessment & Rating Form(Up to 2 weeks pre-training, up to 2 weeks post-training, 10-12 weeks from the start of treatment delivery with a patient, 24-26 weeks from the start of treatment delivery with a patient)
- Patient treatment satisfaction scores on the Treatment Satisfaction Questionnaire (TSQ) at post-treatment(10-12 weeks from the start of treatment (post-treatment))
- Patient changes in tic-related impairment as measured by the Yale Global Tic Severity Scale (YGTSS) Overall Tic Related Impairment Scores(Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up))
- Patient treatment satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at follow-up(24-26 weeks from the start of treatment (6-month follow-up))
- Changes in psychological/behavioral symptoms and adaptive functioning as indicated by change scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric/Parent Proxy Profile 25 (for child patients & caregivers only)(Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up))
- Changes in psychological/behavioral symptoms and adaptive functioning as indicated by change scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile (for adult patients only)(Up to 2 weeks prior to starting treatment (baseline), 10-12 weeks from the start of treatment (post-treatment), 24-26 weeks from the start of treatment (6-month follow-up))