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Modified CBIT Treatment Arm for Tourette Syndrome (M_CBIT Trial)

N/A
Waitlist Available
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3months following end-point (26 weeks)
Awards & highlights
No Placebo-Only Group

Summary

The main purpose of this trial is to develop and investigate the effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents with chronic tic disorders and ADHD. CBIT is a first-line behavioral treatment for individuals with tic disorders. However, the benefit of CBIT is mitigated in those with co-occurring ADHD, as ADHD is negatively associated with effect size in behavioral treatments for tics. Additionally, while tic disorders are associated with reduced quality of life measures, CBIT is 'tic-specific.' Despite improving tics, measures do not show associated improved quality of life. Currently, there are no standardized behavioral treatments for tics that account for ADHD symptoms and/or addresses the impact that tics and ADHD symptoms have on quality of life. The first aim is to develop a treatment protocol that combines elements from CBIT, Cognitive Behavioral Therapy (CBT) for ADHD and factors targeting psychosocial impairment. The second aim is to determine the treatment feasibility and acceptability (e.g. retention, reasons for treatment refusal and dropout, and motivation) of this modified CBIT treatment. The investigators will evaluate and assess the randomization process, the treatment modules, and the expectations and satisfaction of the participants and their parents. The final aim is to use a pilot randomized control trial (RCT) design to evaluate improvement using measures including tic, ADHD and quality of life scales as rated by a blinded clinician. Though the investigators will evaluate efficacy of the modified protocol, the primary purpose will remain feasibility. The hope is to use this study to develop larger trials in the future.

Eligible Conditions
  • Tourette Syndrome
  • Attention Deficit Hyperactivity Disorder (ADHD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3months following end-point (26 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3months following end-point (26 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Expectancy Therapy Evaluation Form
Patient Satisfaction Questionnaire
Satisfaction Scale for Module 1
+11 more
Secondary study objectives
Attention deficit hyperactivity disorder
Clinical Global Impression - Improvement Scale
Clinical Global Impression - Severity Scale
+4 more
Other study objectives
Child Tourette's Syndrome Impairment Scale
Mental Depression
Children's Yale-Brown Obsessive Compulsive Scale
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Modified CBIT Treatment ArmExperimental Treatment1 Intervention
In this arm, participants will receive the modified CBIT protocol. In addition to addressing tics, the treatment in this arm will also directly address ADHD symptoms using CBT for ADHD techniques, and quality of life concerns. The treatment itself will be modified to be more accessible to an ADHD population. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention.
Group II: Standard CBIT Treatment ArmActive Control1 Intervention
In this arm, participants will receive the standard CBIT intervention (Piacentini et al 2010). The primary components of CBIT are habit reversal training, relaxation training and a functional interventional to assess the environment for situations/factors that exacerbate or sustain tics. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Modified Comprehensive Behavioral Intervention for Tics
2016
N/A
~20

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,010 Previous Clinical Trials
13,309,003 Total Patients Enrolled
5 Trials studying Tourette Syndrome
435 Patients Enrolled for Tourette Syndrome
~2 spots leftby Nov 2025