Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E)

NCT ID: NCT05050734

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-09-01

Brief Summary

The purpose of this pilot trial is to examine the preliminary efficacy of online-delivered Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E). In the study, 30 children with persistent tic disorders (PTDs) will be recruited via information provided to patients of the Marquette University (MU) Tic Disorders Specialty Clinic (TDSC) and information conveyed via local medical health professionals, with the goal of randomizing 10 participants to each group. For those randomized to CBIT-E, treatment will be administered according to the standard CBIT manual, but there will be two modifications. CBIT typically consists of the implementation of strategies to help manage the environment related to tics and the implementation of an exercise to engage in when an individual feels the urge to tic. CBIT-E will include these same techniques, plus additional in-session and out of session practice of the exercises, called competing responses, that individuals use when they feel the urge to tic. Treatment will be delivered over Microsoft Teams, which is a secure video conferencing system. The therapist will administer treatment from a private room in the Marquette University Tic Disorder Specialty Clinic, while the parent and child will be at their home. Treatment will include a screening visit, baseline assessment, 11 weeks (9 sessions) of CBIT-E, a post treatment assessment, and a three-month follow up assessment. Further, starting after session 3, there will be four 15-minute practice periods scheduled each week between sessions. During these practice periods, the child and therapist will meet over Microsoft Teams and the therapist will administer an enhanced reward task.

Children randomized to the waitlist control (WLC) will not receive treatment during the 11-week period. Instead, they will be placed on a waitlist to receive standard CBIT following the end of the study period. Participants in this group will complete a screening visit, baseline assessment, and a final assessment, which will occur approximately 11 weeks after baseline.

Conditions

Persistent Tic Disorders; Tourette Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CBIT-E

For those randomized to CBIT-E, treatment will be administered according to the standard CBIT manual, which includes psychoeducation, functional assessment/interventions, habit reversal training, relaxation techniques, and a motivational reward program. However, there will be two modifications. CBIT-E will include additional in-session and out of session practice of exercises, called competing response. Treatment will include a screening visit, baseline assessment, 11 weeks (9 sessions) of CBIT-E, a post treatment assessment, and a three-month follow up assessment. Further, starting after session 3, there will be four 15-minute practice periods scheduled each week between sessions. During these practice periods, the child and therapist will meet over Microsoft Teams and the therapist will administer an enhanced reward task.

Group Type: EXPERIMENTAL

Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E)

Intervention Type: BEHAVIORAL

Behavioral treatment for persistent tic disorders.

Waitlist Control (WLC)

These participants will not receive treatment during the 11-week period. Instead, they will be placed on a waitlist to receive standard CBIT following the end of the study period. The final assessment will be approximately 11 weeks after baseline.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E)

Behavioral treatment for persistent tic disorders.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ages 9-17
• meets Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for TD or PTD
• at screening visit, a Parent Tic Questionnaire (PTQ) total score > 18 and < 60 OR > 12 and < 40 if persistent tic disorder (for total scores > 60 on the PTQ, the research team will examine the patient's global functioning to determine participation appropriateness. The research team will consider if other treatments, such as medication, may be more appropriate for participants with PTQ total scores > 60. If the participant is already taking tic medication, or tic medication has been unsuccessful in the past, then he/she may be considered for the study)
• at baseline visit, a Yale Global Tic Severity Score (YGTSS Total Score) > 14 and < 30 OR > 10 and < 20 if persistent tic disorder (for total scores > 30 on the YGTSS, the research team will examine the patient's global functioning to determine participation appropriateness)
• no history of behavioral treatment for tics, including self-guided therapy programs for tics
• unmedicated or on stable medication for tics and other psychiatric disorder for at least 6 weeks, with no planned changes during study participation
• access to a personal computer (desktop or laptop) with a camera
• access to an Internet connection with a minimum speed of 5 megabytes per second (Mbps)
• fluent English speaker.

Exclusion Criteria

• co-occurring disorders that require more immediate treatment or change to current treatment
• T-Score < 37 on the Wechsler Abbreviated Scale of Intelligence (WASI) - Vocabulary subtest
• T-Score > 70 on the inattention or hyperactivity/impulsivity scales of the Conners 3-Parent Short (C 3-PS).

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

Marquette University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Marquette University

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jordan T Stiede, M.S.

Role: CONTACT

jordan.stiede@marquette.edu

414-288-6177

Facility Contacts

Jordan T. Stiede, M.S.

Role: primary

jordan.stiede@marquette.edu

414-288-6177

Other Identifiers

HR-3837

Identifier Type: -

Identifier Source: org_study_id