NCT02900144

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2019

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

2.6 years

First QC Date

September 1, 2016

Last Update Submit

September 15, 2021

Conditions

Tourette SyndromeADHD

Outcome Measures

Primary Outcomes (17)

  • Patient Satisfaction Questionnaire

    Scale that measures the subject's satisfaction with the treatment

    26 weeks

  • Expectancy Therapy Evaluation Form

    Rates subject's expectations about effectiveness of the treatment

    Baseline

  • Satisfaction Scale for Module 1

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    1 week

  • Expectancy Therapy Evaluation Form

    Rates subject's expectations about effectiveness of the treatment

    6 weeks

  • Satisfaction Scale for Module 2

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    2 weeks

  • Satisfaction Scale for Module 3

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    3 weeks

  • Satisfaction Scale for Module 4

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    4 weeks

  • Satisfaction Scale for Module 5

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    5 weeks

  • Satisfaction Scale for Module 6

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    6 weeks

  • Satisfaction Scale for Module 7

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    7 weeks

  • Satisfaction Scale for Module 8

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    8 weeks

  • Satisfaction Scale for Module 9

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    9 weeks

  • Satisfaction Scale for Module 10

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    10 weeks

  • Satisfaction Scale for Module 11

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    12 weeks

  • Satisfaction Scale for Module 12

    Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.

    14 weeks

  • Patient Satisfaction Questionnaire

    Scale that measures the patient's satisfaction with the treatment

    6 weeks

  • Patient Satisfaction Questionnaire

    Scale that measures the patient's satisfaction with the treatment

    14 weeks

Secondary Outcomes (41)

  • Yale Global Tic Severity Scale

    Change from baseline to mid-point (6 weeks)

  • Yale Global Tic Severity Scale

    Change from baseline to end-point (14 weeks)

  • Yale Global Tic Severity Scale

    Change from baseline to 3months following end-point (26 weeks)

  • Vanderbilt Assessment Scale - ADHD

    Change from baseline to mid-point (6 weeks)

  • Vanderbilt Assessment Scale - ADHD

    Change from baseline to end-point (14 weeks)

  • +36 more secondary outcomes

Other Outcomes (27)

  • Children's Yale-Brown Obsessive Compulsive Scale

    Change from baseline to mid-point (6 weeks)

  • Children's Yale-Brown Obsessive Compulsive Scale

    Change from baseline to end-point (14 weeks)

  • Children's Yale-Brown Obsessive Compulsive Scale

    Change from baseline to 3months following end-point (26 weeks)

  • +24 more other outcomes

Study Arms (2)

Modified CBIT Treatment Arm

EXPERIMENTAL

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.

Behavioral: Modified Comprehensive Behavioral Intervention for Tics

Standard CBIT Treatment Arm

ACTIVE COMPARATOR

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.

Behavioral: Comprehensive Behavioral Intervention for Tics

Interventions

Modified Comprehensive Behavioral Intervention for TicsBEHAVIORAL

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.

Modified CBIT Treatment Arm
Comprehensive Behavioral Intervention for TicsBEHAVIORAL

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.

Standard CBIT Treatment Arm

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Have a DSM-5-based diagnosis of Tourette Syndrome or Persistent Motor or Vocal Tic Disorder
  • Have a diagnosis of ADHD by DSM-5 standards, or a previous diagnosis of ADHD where there are some residual symptoms (at least 7/18) but does not currently meet diagnostic criteria due to current medications.
  • Tic disorder is the most problematic psychiatric disorder and the primary reason for seeking treatment
  • Have a current total tic severity score of \>13 (or \>9 if CTD) on the Yale Global Tic Severity Score (YGTSS), and a current total impairment score of \>19 on the YGTSS
  • Be male or female and between 10-17 years of age at the start of the treatment, inclusive
  • Be able to communicate meaningfully with the investigators and be competent to provide written assent; both parental informed consent and adolescent assent must be obtained
  • Be English speaking

You may not qualify if:

  • Comorbid psychiatric diagnoses including: alcohol or substance abuse or dependence within the past 3 months, psychosis, organic mental disorder, current mania, developmental delay, estimated IQ \<80 on the Wechsler Abbreviated Scale of Intelligence (WASI), other cognitive impairment that would interfere with ability to engage in CBT, or other developmental/cognitive impairment that precludes the participant from being able to communicate meaningfully with the treater
  • Those deemed to pose a serious suicidal or homicidal threat (e.g., suicide attempt within past 6 months and/or endorsement of "I want to kill myself" on the Children's Depression Inventory (CDI)).
  • Current illness (tics or otherwise) so severe that an immediate psychopharmacological evaluation is warranted
  • Any clinical features requiring a higher level of care than outpatient (as determined by evaluator).
  • Intent to travel for a period longer than two weeks (such that three sessions would be missed) during the proposed time-frame of the study. However, this criterion may be waived as per the discretion of the Principal investigator.
  • In general, the participant cannot be engaged in concurrent psychotherapy - if they are, they would need to stop (no lag time required between stopping current therapy and beginning this intervention). Decisions can be made on a case by case basis if the therapy is for a concern/disorder separate from mood, anxiety or OCD-spectrum disorders (e.g. gender dysphoria).
  • Four or more sessions of previous CBT treatment similar to the current treatment (CBIT and/or CBT for ADHD) within the last five years
  • Participants can be receiving psychotropic medication, but they must be on a stable dose for four weeks prior to the study baseline assessment and maintain this dosage throughout the course of the study. If a potential participant is taking psychotropic medication at the time of the phone evaluation or the first in-person study assessment and wishes to discontinue this medication to enter the trial, the participant will be asked to discuss this option with their prescribing physician to determine whether medication discontinuation would be safe and in the participant's best interest. We will not influence the decision or procedures participants choose with their prescribing physician. If the participant decides to discontinue treatment with the psychotropic medication, he/she must wait for four weeks before receiving a baseline assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

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MeSH Terms

Conditions

Tourette SyndromeAttention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTic DisordersMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 1, 2016

First Posted

September 14, 2016

Study Start

September 1, 2016

Primary Completion

April 10, 2019

Study Completion

April 10, 2019

Last Updated

September 16, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)