Psychosocial Intervention for Young Children With Chronic Tics

Learn more about:
Related Clinical Trial
Internet-based Cognitive Behavioral Therapy for Chronic Tic Disorder and Tourette’s Disorder: a Feasibility Trial Longitudinal Impact of Stressors in Adults With Tourette Syndrome Effects of Lactobacillus Plantarum PS128 in Patients With Tourette’s Syndrome Combined CBIT and rTMS to Improve Tourette’s Syndrome Pimavanserin Treatment in TS Median Nerve Stimulation (MNS) Pilot Extinction Learning in Adults With Tourette Syndrome Observational Database on Deep Brain Stimulation in Tourette Syndrome Influence of Stress and Psychiatric Symptoms on Children With Tourette Syndrome D-cycloserine Augmented Treatment for Youth With Tic Disorders Sensory Symptoms in Tourette Syndrome and Obsessive-Compulsive Disorder Atomoxetine in Patients With Tourette’s Syndrome Deep Brain Stimulation in Forel’s H Field in Tourette’s Syndrome Psychosocial Intervention for Young Children With Chronic Tics Brain Tissue Collection for Neuropathological Studies New Stereotactic Frame System for Neurosurgery Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders. Outcomes Mandate National Integration With Cannabis as Medicine Reliability and Validity of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) Brain-Behavior Interactions in Tic Suppression Phase III Study of 5LGr to Treat Tic Disorder Effects of Ondansetron in Obsessive-compulsive and Tic Disorders I-123 Brain Studies of Serotonin Metabolism in Psychiatric Patients and Normal Volunteers Physiological Investigations of Movement Disorders Dissemination of Comprehensive Behavioral Intervention for Tics (CBIT) to Occupational Therapists: A Feasibility Study TicHelper: A Computerized Comprehensive Behavioral Intervention for Tics (CBIT) Safety Study of Galantamine in Tic Disorders Internet-based Coaching for Young Adults With Neuropsychiatric Disorders Modified Comprehensive Behavioral Intervention for Tics (M_CBIT) Incorporating teleCBIT Into a Hospital-Based Tic Program Cognitive Behavior Therapy and Habit Reversal Training for the Treatment of Chronic Tic Disorders in Children An Exploratory Study of Transcranial Magnetic Stimulation (TMS) Based on Functional Magnetic Resonance Imaging (fMRI) in the Treatment of Tic Disorder Brain Stimulation in Movement Disorders Augmentation of Brief Habit Reversal Training With D-cycloserine or Placebo Central Mechanisms in Speech Motor Control Studied With H215O PET Comparison of Keppra and Clonidine in the Treatment of Tics Brain Activation in Vocal and Motor Tics Trial to Demonstrate the Efficacy and Safety of Internet-delivered Behavioral Treatment for Adults With Tic Disorders Assessment of Children With Tic Onset in the Past 6 Months Repetitive Transcranial Magnetic Stimulation to Reduce Tics Guanfacine in Children With Tic Disorders Neuropsychological Functioning Among Children With Tourret’s Disorder and ADHD Investigating Circadian Rhythms in Youth With Persistent Tic Disorders The Role of Probiotics PS128 in Movement Disorders Online Mindfulness-based Tic Reduction (Phase Two) Online Mindfulness-based Tic Reduction Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders A Handwriting Intervention Program for Children With Tic Disorders Study of Clonidine on Sleep Architecture in Children With Tourette’s Syndrome (TS) and Comorbid ADHD National Gilles De La Tourette Study Group Evaluating the Efficacy and Safety of Yi-Gan San in Children and Adolescents With Tourette’s Disorder Evaluation of a Cognitive Psychophysiological Treatment for Tourette Syndrome and Tic Disorders Magnetic Resonance Spectroscopy to Evaluate Tourette s Syndrome Group Intervention for Children With Chronic Tics Syndrome or Tourette Syndrome: CBIT vs Psycho-Educational Intervention Study of the Neurobiology of Tourette Syndrome and Related Disorders Brain Dynamics Involved in Generating Tics and Controlling Voluntary Movement Dopaminergic Effects on Cortical Function in Tourette’s (Levodopa Protocol) Developmental Phenomenology of Obsessive Compulsive Disorder and Tourette Syndrome in Children and Adolescents Online Remote Behavioural Intervention for Tics (ORBIT) CANNAbinoids in the Treatment of TICS (CANNA-TICS) A Study to Test if TEV-50717 is Effective in Relieving Tics Associated With Tourette Syndrome Internet-delivered Behaviour Therapy for Children and Adolescents With Tourette’s Disorder A Study to Evaluate the Effects of ABX-1431 on Patients With Tourette Syndrome Aripiprazole in the Treatment of Tourette’s Syndrome Aripiprazole in Children and Adolescents With Chronic Tic Disorder or Tourette’s Disorder Phase II Double Blind Placebo Controlled Trial of Risperidone in Tourette Syndrome Phase III Randomized, Double-Blind, Placebo-Controlled Study of Guanfacine for Tourette Syndrome and Attention Deficit Hyperactivity Disorder Randomized Study of Pergolide in Children With Tourette Syndrome Phase II Pilot Controlled Study of Short Vs Longer Term Pimozide (Orap) Therapy in Tourette Syndrome tDCS in Tourette (TIC-TDCS) Anger Control Training for Youth With Tourette Syndrome Safety and Tolerability Study of NBI-98854 for the Treatment of Subjects With Tourette Syndrome Neurofeedback for Tourette Syndrome Brain Stimulation for the Treatment of Tourette Syndrome Study of Tics in Patients With Tourette’s Syndrome and Chronic Motor Tic Disorder Timing of Voluntary Movement in Patients With Tourette Syndrome and Chronic Tic Disorder Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome Methylphenidate for Treating Children With ADHD and Tourette Syndrome Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Tourette Syndrome and Seasonality (Stagionalità Tourette) Study Evaluating the Safety and Efficacy of Fixed-dose Once-daily Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Role of the Sensory Experience in Generating Motor Tics in Tourette Syndrome Effectiveness of Behavior Therapy and Psychosocial Therapy for the Treatment of Tourette Syndrome and Chronic Tic Disorder Proof of Concept Study of an Oral Orthotic to Reduce Tic Severity in Chronic Tic Disorder and Tourette Syndrome Evaluation of Safety and Tolerability of Long-term TEV-50717 (Deutetrabenazine) for Treatment of Tourette Syndrome in Children and Adolescents Multi-site Transcranial Magnetic Stimulation Therapy of the Supplementary Motor Area in Children With Tourette Syndrome Open-Label Safety and Tolerability Study of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome A Randomized, Placebo-controlled, Tourette Syndrome Study. A Trial of Bilateral Deep Brain Stimulation to the Globus Pallidus Internum in Tourette Syndrome A Study of the Effectiveness and Safety of Tetrabenazine MR in Pediatric Subjects With Tourette’s Syndrome An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome. Thalamic Deep Brain Stimulation for Tourette Syndrome Exploration of Glutamatergic System With PET Radiotracer in Gilles de la Tourette Patients: Pilot Study (GlutaTour) ABF Tourette’s Disorder Post Marketing Surveillance Study Safety and Efficacy of NBI-98854 in Pediatric Subjects With Tourette Syndrome Brain Activity Associated With Tics in Patients With Tourette Syndrome Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Pediatric Subjects With Tourette Syndrome Internet-based Behaviour Therapy for Tourette’s Disorder and Chronic Tic Disorder Pramipexole Pilot Phase II Study in Children and Adolescents With Tourette Disorder According to DSM-IV Criteria Response Inhibition in Tourette Syndrome Alternatives for Reducing Tics in TS: A Study of TEV-50717 (Deutetrabenazine) for the Treatment of Tourette Syndrome in Children and Adolescents. Safety, Pharmacokinetics, and Pharmacodynamics of NBI-98854 in Children and Adolescents With Tourette Syndrome Pallidal Stimulation and Gilles de la Tourette Syndrome Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device – Safety and Feasibility Study for the Treatment of Tourette Syndrome Pilot Study of the Modified Atkins Diet for Tourette Syndrome Trial to Evaluate the Long-term Efficacy of Oral Aripiprazole in the Treatment of Pediatric Subjects With Tourette’s Disorder Efficacy of a Therapeutic Combination of Dronabinol and PEA for Tourette Syndrome Pilot Study for Use of Dysport in Treatment of Vocal Tics in Patients With Tourette’s Syndrome A Study to Examine the Efficacy of a Therapeutic THX-110 for Tourette Syndrome Open Label Trial of Aripiprazole in Children and Adolescents With Tourette’s Disorder Open-label Extension Study of Pramipexole in the Treatment of Children and Adolescents With Tourette Syndrome Study Evaluating The Safety And Efficacy Of PF-03654746 In Adult Subjects With Tourette’s Syndrome Safety & Tolerability Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Hypersensitivity in Tourette Syndrome Role of Frontal Cortex in the Pathophysiology of Gilles de la Tourette Syndrome (GTS) Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Efficacy & Safety Study of Once-weekly Oral Aripiprazole in Children and Adolescents With Tourette’s Disorder Safety and Efficacy Study of NBI-98854 in Adults With Tourette Syndrome VoIP Delivered Behavior Therapy for Tourette Syndrome Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome Study of ABX-1431 in Adult Patients With Tourette Syndrome or Chronic Motor Tic Disorder Subthalamic Stimulation in Tourette’s Syndrome Study of GABA-A Receptors in the Generation of Tics in Patients With Tourette’s Syndrome Transcranial Magnetic Stimulation (TMS) for Individuals With Tourette’s Syndrome Neural Correlates of Sensory Phenomena in Tourette Syndrome Sensory Symptoms in Tourette Syndrome Tourette Syndrome Deep Brain Stimulation The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome Safety, Tolerability, Pharmacokinetic, and Efficacy Study of AZD5213 in Adolescents With Tourette’s Disorder Aripiprazole Oral Solution in the Treatment of Children and Adolescents With Tourette’s Syndrome Facial Expression Recognition of Emotion and Categorization of Emotional Words in Gilles de la Tourette’s Syndrome Thalamic Deep Brain Stimulation for Tourette Syndrome Rollover Study for Continuing NBI-98854 Administration in Pediatric Subjects With Tourette Syndrome The Effect and Safety of Plum-blossom Needle for Tourette Syndrome Proof-of-Concept Safety Study of CPP-109 (Vigabatrin) for Treatment Refractory Tourette’s Disorder Ecopipam Treatment of Tourette Syndrome High Frequency Stimulation of the GPi or Thalamus in Tourette’s Syndrome Computerized Working Memory Training in Children With ADHD and Comorbid Tourette Syndrome Optimising Anterior Pallidal Deep Brain Stimulation for Tourette’s Syndrome MRI Study of Tic Remission in Tourette Syndrome Thalamic Deep Brain Stimulation for the Treatment of Refractory Tourette Syndrome Selective Microbiota Transplantation for Tourette’s Syndrome Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome A Pilot Study Of SD-809 (Deutetrabenazine) In Moderate To Severe Tourette Syndrome (TS) Impulsivity in Tourette Syndrome : Behavioral and Neuroimaging Study Developing Cognitive Training for Tourette Syndrome A Trial Evaluating the Efficacy, Safety, and Pharmacokinetics of SNC-102 in Subjects With Tourette Syndrome Safety and Efficacy of Cannabis in Tourette Syndrome Activity in Tourette Syndrome FAAH Inhibitor Trial for Adults With Tourette Syndrome Open-Trial of EPI-743 for Adults With Tourette Syndrome Omega-3 Fatty Acids in Tourette’s Disorder Do Mirror Neurons Play a Role in Tourette Syndrome Physiopathology? A Pilot Study. Apathy in Tourette Syndrome and Changes in Quality of Life Sensory Processing in Tourette Syndrome The Pathophysiology of Tourette Syndrome: a Multimodal Study Behavioral Therapy for Tourette Syndrome Behavioral Therapy for Children and Adolescents With Tourette Syndrome Ecopipam Treatment of Tourette’s Syndrome in Subjects 7-17 Years Transcranial Magnetic Stimulation for Children With Tourette’s Syndrome

Brief Title

Psychosocial Intervention for Young Children With Chronic Tics

Official Title

Psychosocial Intervention for Young Children With Chronic Tics

Brief Summary

      Analysis of data from the recently completed NIH Child Comprehensive Behavioral Intervention
      for Tics (CBIT) study found a manualized behavioral treatment approach strongly superior to
      psychoeducation/supportive therapy for reducing tic severity in 9-16 year-old youths with TS
      or other Chronic Tic Disorders. Buoyed by the success of the NIH study, the research group
      now seeks to extend and disseminate the CBIT treatment through the systematic adaptation of
      the CBIT protocol for use across a broader range of ages and treatment settings.

      The goal of the this project is to develop a downward extension of the CBIT therapist guide
      and parent workbook for use in 4-8 year old children with chronic tics. The revised CBIT-JR
      manual/workbook will be pilot tested in five children at each of the three study sites (UCLA,
      UWM, Weill Cornell) in order to provide initial data regarding treatment feasibility and
      acceptability as well as our ability to implement the new intervention, along with relevant
      quality control procedures, consistently across sites. These pilot data will then be used to
      seek R01 support for a larger controlled multisite trial examining the efficacy of CBIT-JR.

      Although arguably more complex than a single-site design, we have opted for a multsite study
      in order: 1) to take advantage of the established productive collaborative relationship and
      collective expertise in childhood tic disorders and psychosocial treatment development across
      our three sites, 2) to collect the proposed feasibility data in a much shorter period of time
      than otherwise possible, and as noted above 3) to demonstrate the cross-site portability of
      the treatment - which will be necessary if we are to obtain subsequent funding for a
      larger-scale efficacy trial.
    

Detailed Description

      The overall aim of the proposed project is to develop and obtain preliminary feasibility and
      acceptability data for a family-based behavioral intervention to reduce tic severity and the
      negative impact of TS-related symptoms in young children (ages 4-8) with chronic tics and
      Tourette syndrome. This intervention entails the use of targeted psychoeducation about tics
      and related conditions and a functional analytic protocol designed to identify and correct
      environmental influences thought to exacerbate and/or maintain child tic expression. Although
      similar to the family-based component used in our recently completed CBITS trial for older
      children, an independent body of literature supports the efficacy of functional analysis for
      ameliorating a variety of both behaviorally and biologically-driven behaviors. The
      investigators will work with an early child interventionist to adapt the current family-based
      protocol for younger children. The new manual will then be feasibility tested in anticipation
      of a larger externally-funded trial to further develop and evaluate the efficacy of this
      intervention.

      More specifically, the study aims are to:

        1. Adapt the current CBIT Manual for use with the families of 4-8 year old children with
           chronic tic disorder. Our revision will be informed by a meeting of the study PI's and
           Dr. Mary O'Connor, an early childhood interventionist at UCLA to review our current
           family-intervention and other treatment protocols targeting related psychopathology in
           young children.

        2. Document the feasibility, acceptability, and cross-site portability of the new manual in
           a small open trial of 15 youngsters (five each at UCLA, UWM, and Weill Cornell).
    


Study Type

Interventional


Primary Outcome

Yale Global Tic Severity Scale (YGTSS).


Condition

Tourette's Syndrome

Intervention

Comprehensive Behavioral Intervention for Tics (CBIT)

Study Arms / Comparison Groups

 Open Trial
Description:  This is a non-randomized open trial of a behavioral intervention for young children with tics

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

15

Start Date

January 20, 2012

Completion Date

February 2013

Primary Completion Date

December 29, 2012

Eligibility Criteria

        Inclusion Criteria:

          1. age 4-8

          2. presence of motor and/or vocal tics for at least 6 months.

          3. tics are of at least moderate clinical severity as evidenced by a Clinical Global
             Impressions (CGI) Severity score of 4 or higher (tic symptoms clearly noticeable to
             family and occasionally to families and associated with at least some minimal level of
             distress and/or interference.

          4. free of PDD or other developmental disability

          5. IQ estimate of 70 or higher

          6. comorbid disorder (e.g., ADHD, OCD, ODD) will be allowed provided that the tic
             symptoms are of primary concern to parents and comorbid symptoms are not of sufficient
             severity to require immediate treatment other than that provided by the current study.

          7. pre-existing stable medication, tic or otherwise, will also be allowed provided the
             family agrees to refrain from med changes over the course of the study if at all
             possible.

          8. sufficient command of the English language to comply with study protocol.

        Exclusion Criteria:

        -
      

Gender

All

Ages

4 Years - 8 Years

Accepts Healthy Volunteers

No

Contacts

Shannon Bennett, PhD, , 



Administrative Informations


NCT ID

NCT03042507

Organization ID

1012011424R005


Responsible Party

Sponsor

Study Sponsor

Weill Medical College of Cornell University

Collaborators

 University of California, Los Angeles

Study Sponsor

Shannon Bennett, PhD, Principal Investigator, Weill Medical College of Cornell University


Verification Date

July 2019