Pilot Trial of Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E)

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Brief Title

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

Official Title

A Randomized Waitlist-Controlled Pilot Trial of Online-Delivered Comprehensive Behavioral Intervention for Tics-Enhanced (CBIT-E)

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.
    



Study Type

Interventional


Primary Outcome

Yale Global Tic Severity Scale (YGTSS)

Secondary Outcome

 Clinical Global Impression-Improvement (CGI-I) Scale

Condition

Persistent Tic Disorders

Intervention

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

Study Arms / Comparison Groups

 CBIT-E
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

30

Start Date

September 15, 2021

Completion Date

September 1, 2022

Primary Completion Date

September 1, 2022

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).
      

Gender

All

Ages

9 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

, 414-288-6177, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05050734

Organization ID

HR-3837


Responsible Party

Sponsor

Study Sponsor

Marquette University

Collaborators

 University of Utah

Study Sponsor

, , 


Verification Date

October 2021