Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2012-12-31
2013-11-30
Brief Summary
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Detailed Description
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Therefore the objective of this study (the final phase of a three-phase project) is to establish the preliminary efficacy of VoIP-modified CBIT for reducing tics in children with TS relative to a waitlist-control. Twenty children (ages 9-17) with TS or Chronic Tic Disorder as a primary diagnosis will be recruited for a randomized, observer-blind, waitlist controlled trial of VoIP-delivered CBIT. Participants will be randomly assigned to 8 weekly sessions of CBIT-VoIP over a 10-week acute treatment period, or waitlist control condition. As an exploratory aim, the current study will investigate potential correlates of treatment outcome, including home computer equipment available (i.e., web camera type, microphone type, internet upload speed, and type of internet connection), prior computer experience, and comfort with study computer equipment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Behavior Therapy for Tics (CBIT)
The child 1) learns to become more aware of any sensations, or urges that may trigger tics, and 2) learn some other behavior (competing response) to do every time he/she feels the urge to tic. The child's parent is trained to provide prompts and praise for use of the competing response. The parent and family also receive psychoeducation about tics, and learn ways to reduce the impact of environmental stimuli on tic severity. The child learns relaxation techniques to reduce stress and make it easier for him/her to resist his or her tics. Prior to treatment sessions, the parent and child spend about 10 minutes discussing with the therapist any problematic issues he/she is having. At the end of treatment sessions the child is assigned some tasks to practice prior to the next session.
Behavior Therapy for Tics (CBIT)
CBIT is an 8-session 10-week behavioral treatment for chronic tic disorders, including Tourette Syndrome. The first two sessions are 90 minutes, with subsequent sessions lasting 60 minutes. The treatment consists of Habit Reversal Training (awareness training, competing response training, and social support), and function-based assessment to reduce the impact of environmental or other stimuli on tic severity. The treatment also consists of relaxation techniques to reduce tic-related stress and tension, and behavioral rewards to motivate treatment compliance.
Waitlist-control Group
Participants in the waitlist-control group, do not receive behavior therapy for tics or any other treatment during the 10-week acute treatment period. Instead they child are placed on a waitlist to receive videoconference-delivered treatment following the end of the study period.
No interventions assigned to this group
Interventions
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Behavior Therapy for Tics (CBIT)
CBIT is an 8-session 10-week behavioral treatment for chronic tic disorders, including Tourette Syndrome. The first two sessions are 90 minutes, with subsequent sessions lasting 60 minutes. The treatment consists of Habit Reversal Training (awareness training, competing response training, and social support), and function-based assessment to reduce the impact of environmental or other stimuli on tic severity. The treatment also consists of relaxation techniques to reduce tic-related stress and tension, and behavioral rewards to motivate treatment compliance.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ages 8-17
* Meets DSM-IV-TR diagnostic criteria for Chronic Tic Disorder (CMVT or TS)
* Clinical global Impressions - Severity Score greater than or equal to 4 (moderately ill)
* YGTSS Total Score greater than or equal to 14 and less than 30 OR Total Score greater than or equal to 10 and less than 20 if CTD with motor tics only
* Unmedicated or on stable medication treatment for tics, OCD, ADHD, anxiety, and/or depressive disorder for at least 6 weeks, with no planned changes for duration of study participation
* Fluent English speaker
Exclusion Criteria
* WASI-Vocab subtest T-Score \< 37
* DSM-IV substance abuse or dependence or Conduct Disorder within the past 3 months
* Lifetime DSM-IV diagnosis of Pervasive developmental disorder, Mania, or Psychotic Disorder
* Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current
* Previous treatment with HRT for tics (four or more sessions)
* Lack of a functional, and accessible home computer, and high speed (i.e., cable/DSL) internet connection
* Refusal to sign a release of information form for the child's local primary care physician, mental health professional, or neurologist.
8 Years
17 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
University of Utah
OTHER
University of Wisconsin, Milwaukee
OTHER
Responsible Party
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Emily Ricketts
Doctoral Student
Principal Investigators
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Emily J Ricketts, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Milwaukee
Douglas W Woods, PhD
Role: STUDY_DIRECTOR
Texas A&M University
Michael B Himle, PhD
Role: STUDY_CHAIR
University of Utah
Locations
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University of Wisconsin-Milwaukee Psychology Department
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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