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

NCT05050734 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-10-08

No results posted yet for this study

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

Interventions

BEHAVIORAL

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

Behavioral treatment for persistent tic disorders.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2022-09-01
Completion
2022-09-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05050734 on ClinicalTrials.gov