Clinical trial NCT05547854: Evaluation of an Online Comprehensive Behavioral Intervention for Tics (CBIT) Therapist Training Program
Official title: Finalizing and Testing an Online Therapist Training and Assistance Program to Facilitate Implementation of Comprehensive Behavioral Intervention for Tic Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tics
Tic Disorders
Tourette Syndrome
Keywords: Comprehensive Behavioral Intervention for Tics
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Marquette University
name: PsycTech, LLC
First posted: 2022-09-21
Enrollment: 234
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effectiveness-implementation hybrid non-inferiority trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: This study will recruit therapist-patient dyads who meet the criteria below:

Therapist Inclusion Criteria:

1. Have the equivalent of a Master's degree (or higher) in a mental/behavioral health, medical, or related discipline.
2. Professionally licensed or certified to practice in their area of speciality.
3. 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.
4. Have never attended the Tourette Association of America's Behavior Therapy Training Institute or an equivalent focused on CBIT.
5. Have access to a secure personal computer with high-speed internet access.
6. Speaks fluent English.
7. 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.
8. Is willing to be randomly assigned to training condition.
9. 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.

Therapist 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:

1. 7 years of age or older (with consenting adult for minors).
2. 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.
3. Currently engages in at least one motor and/or vocal tic multiple times per day.
4. Patient (and consenting adult for minors) speaks fluent English.
5. Access to a private computer with high-speed internet access.

Patient Exclusion Criteria:

1. Patients will be excluded if the study team is unable to identify and enroll a patient-matched therapist who meets the therapist inclusion criteria.
2. 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.
3. Any serious psychiatric or neurological condition that requires more immediate intervention or would interfere with study participation, based on the assessment of the treating therapist or the study investigators.

Primary outcomes:
measure: Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-training
timeFrame: up to 2 weeks post-training
measure: Therapist scores on the CBIT Fidelity Checklist and Rating Scale at post-treatment
timeFrame: 10-12 weeks post-training
measure: Therapist scores on the CBIT Fidelity Checklist & Rating Scale at 6-month follow-up
timeFrame: 24-26 weeks post-training
measure: Proportion of treatment responders at post-treatment on the Clinical Global Impression Improvement Scale (CGI-I)
timeFrame: 10-12 weeks from the start of treatment (post-treatment)
measure: Proportion of treatment responders at follow-up on the Clinical Global Impression Improvement Scale (CGI-I)
timeFrame: 24-26 weeks from the start of treatment (6-month follow-up)
measure: Patient changes in overall symptom severity on the Clinical Global Impression Severity Scale (CGI-S)
timeFrame: 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)
Secondary outcomes:
measure: Therapist change scores on the Tic Disorder & CBIT Knowledge Test
timeFrame: Up to 2 weeks pre-training and up to 2 weeks post training
measure: Therapist changes in self-efficacy to treat tic disorders as measured by the Therapist Self-Assessment & Rating Form
timeFrame: 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
measure: Patient changes in tic severity as measured by the Yale Global Tic Severity Scale (YGTSS) Total Tic Score
timeFrame: 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)
measure: Patient changes in tic-related impairment as measured by the Yale Global Tic Severity Scale (YGTSS) Overall Tic Related Impairment Scores
timeFrame: 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)
measure: Patient treatment satisfaction scores on the Treatment Satisfaction Questionnaire (TSQ) at post-treatment
timeFrame: 10-12 weeks from the start of treatment (post-treatment)
measure: Patient treatment satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at follow-up
timeFrame: 24-26 weeks from the start of treatment (6-month follow-up)
measure: 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)
timeFrame: 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)
measure: 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)
timeFrame: 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)
Other outcomes:
measure: Therapist change scores on the Evidence-Based Practice and Attitudes Scale (EBPAS)
timeFrame: Immediately pre- and 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
measure: Therapist scores on the Acceptability of Intervention Measure (AIM) at post-training
timeFrame: Immediately post-training
measure: Therapist scores on the Acceptability of Intervention Measure (AIM) at post-treatment
timeFrame: 10-12 weeks from the start of treatment delivery with a patient
measure: Therapist scores on the Acceptability of Intervention Measure (AIM) at follow-up
timeFrame: 24-26 weeks from the start of treatment delivery with a patient
measure: Therapist scores on the Intervention Appropriateness Measure (IAM) at post-training
timeFrame: Immediately post-training
measure: Therapist scores on the Intervention Appropriateness Measure (IAM) at post-treatment
timeFrame: 10-12 weeks from the start of treatment delivery with a patient
measure: Therapist scores on the Intervention Appropriateness Measure (IAM) at follow-up
timeFrame: 24-26 weeks from the start of treatment delivery with a patient
measure: Therapist scores on the Feasibility of Intervention Measure (FIM) at post-training
timeFrame: Immediately post-training
measure: Therapist scores on the Feasibility of Intervention Measure (FIM) at post-treatment
timeFrame: 10-12 weeks from the start of treatment delivery with a patient
measure: Therapist scores on the Feasibility of Intervention Measure (FIM) at follow-up
timeFrame: 24-26 weeks from the start of treatment delivery with a patient
measure: Number of patients reporting adverse events
timeFrame: Post-treatment (week 10) & 6-month follow-up (week 24)
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Milwaukee
country: United States
facility: Marquette University
state: Wisconsin
Study officials:
affiliation: PsycTech, LLC
name: Suzanne Mouton-Odum, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Michael Himle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marquette University
name: Doug Woods, PhD
role: PRINCIPAL_INVESTIGATOR
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