Modified Comprehensive Behavioral Intervention for Tics (M_CBIT)

ADHD Clinical Trial

— M_CBIT  

Official title:

Modified Comprehensive Behavioral Intervention for Tics: Treating Children With Tic Disorders, Co-occurring ADHD and Psychosocial Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02900144
• Other study ID #: 2016P001396
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: April 10, 2019

Study information

• Verified date: September 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Comprehensive behavior intervention for tics (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 address the impact that tics and ADHD symptoms have on quality of life. The main purpose of this trial is to develop and then investigate the effects of a modified comprehensive behavioral intervention for tics (CBIT) protocol for children and adolescents with chronic tic disorders and ADHD.

Aim 1: Development a treatment protocol. 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. A new treatment protocol, called "Living With Tics" was recently developed by Dr. Eric Storch et al to help improve quality of life in those with tic disorders. In addition to incorporating components of modules of the above listed treatments, the modules themselves will be adapted to be more accessible to those with ADHD. As tic disorders often have a significant impact on the family, the investigators will incorporate parent involvement into the treatment as well.

Aim 2: Treatment Feasibility and Acceptability. The investigators' second aim is to determine the treatment feasibility and acceptability of the developed protocol. They will examine the retention rates, reasons for treatment refusal and dropout, and subject/parents motivation for this modified CBIT treatment. They plan to evaluate and assess the randomization process, the treatment modules, and the expectations and satisfaction of the participants and their parents. They will use measures including expectancy and satisfaction scales, and Likert scales will be provided at the end of each session to help determine which components of the modules were most and/or least helpful. From those results, the investigators can continue to adapt the treatment protocol for future, larger studies.

Aim 3: Pilot test the treatment's effectiveness. The final aim is to conduct a pilot randomized control trial (RCT) to test the developed protocol in youth with tic disorders and co-morbid ADHD. Half the subjects will undergo treatment with the modified protocol, and half of the subjects will receive standard CBIT treatment. A broad range of outcome measures will be used to evaluate tic symptoms, ADHD symptoms, and quality of life, and predictors of treatment response will be explored. The following scales will be used: Yale Global Tic Severity Scale (YGTSS), NICHQ Vanderbilt Assessment Scales, and Pediatric Quality of Life Inventory-Child Version (PedsQL) scale, as rated by a blinded clinician. Additionally, the investigators will compare which components were most/least helpful to subjects. Though the investigators will evaluate efficacy of the modified protocol, the primary purpose will remain feasibility. The investigators hope to use this study to develop larger randomized controlled trials in the future.

The modified CBIT treatment will be based on the original CBIT protocol developed by Dr. John Piacentini et al in 2010, a CBT for ADHD in adolescents protocol recently developed by Dr. Susan Sprich et al, and Dr. Eric Storch's "Living with Tics" protocol. Techniques from other studies, which combined and adapted protocols will be incorporated as well.

The treatment will be divided into three phases: Evaluation/Psychoeducation, Basic Intervention, and Relapse Prevention, with a total of 12 sessions.

Prior to beginning the treatment, to make sure the subject qualifies, parent(s) and subject will be asked to come in to complete a baseline assessment component.

Evaluation/Psychoeducation (Sessions 1-2): The first 1-2 sessions will focus on assessing the subject's tics and ADHD symptoms, and assessing the impact of tics and ADHD on the subjects' lives. Psychoeducation about tics/Tourette Syndrome and ADHD, and the CBIT and CBT models will be provided. The therapist will create a hierarchy with the patient regarding which tics are most bothersome and what other symptoms/stressors are most impactful on everyday life. Planning and organizing skills and the idea of function-based interventions will also be introduced. Participants will be encouraged to bring their parent(s) to these initial assessment sessions to familiarize the parent(s) with the treatment methods and allow them to ask questions about tics and ADHD and/or the intervention. If appropriate, parents will be involved in the treatment or homework procedures, but this will vary depending on the comfort level and potential benefit as assessed for each child.

Basic Interventions (Session 3 to Session 10): Beginning in Session 3, basic CBIT, cognitive and behavioral methods will be taught during office sessions and assigned as homework throughout the treatment. In addition to including modules that will specifically target ADHD symptoms (such as those on organization and planning and distractibility), modules in general will be designed to target an ADHD population. Modules will include a combination of activity schedules, positive reinforcements to promote on-task behavior, short "brain breaks" in between activities, repetition of key concepts, and the use of visual aides during the sessions and between sessions at home. Handouts describing the topics covered will also be provided to the parent/patient at the conclusion of each session. Relaxation techniques will be incorporated. Some adapted modules from "Living with Tics" will be included depending on the patients' identified difficulties.

Relapse Prevention (Sessions 11-12): The final sessions, each spaced two weeks after the last session, will focus on relapse prevention. The purpose of the spaced sessions in to allow the patient to get more practice and learn to be their own therapist in between meetings. Residual problems and fears about ending treatment will be addressed, and unrealistically optimistic or pessimistic thoughts about treatment termination will be challenged. Patients will learn to anticipate possible symptom recurrence and its relationship to stress, mood, and other factors; counter negative thoughts about setbacks; and handle lapses and setbacks. Parents will also be encouraged to attend the last session(s) if the child/adolescent or clinician feels it would be appropriate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 10, 2019
• Est. primary completion date: April 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

1. Have a DSM-5-based diagnosis of Tourette Syndrome or Persistent Motor or Vocal Tic Disorder

2. 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.

3. Tic disorder is the most problematic psychiatric disorder and the primary reason for seeking treatment

4. 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

5. Be male or female and between 10-17 years of age at the start of the treatment, inclusive

6. 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

7. Be English speaking

Exclusion Criteria:

1. 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

2. 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)).

3. Current illness (tics or otherwise) so severe that an immediate psychopharmacological evaluation is warranted

4. Any clinical features requiring a higher level of care than outpatient (as determined by evaluator).

5. 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.

6. 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).

7. Four or more sessions of previous CBT treatment similar to the current treatment (CBIT and/or CBT for ADHD) within the last five years

8. 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.

Related Conditions & MeSH terms

• ADHD
• Tourette Syndrome

Intervention

Behavioral:
• Modified Comprehensive Behavioral Intervention for Tics
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.
• Comprehensive Behavioral Intervention for Tics
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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

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* Note: There are 52 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Children's Yale-Brown Obsessive Compulsive Scale	Assesses severity of obsessive-compulsive symptoms in the last week	Change from baseline to mid-point (6 weeks)
Other	Children's Yale-Brown Obsessive Compulsive Scale	Assesses severity of obsessive-compulsive symptoms in the last week	Change from baseline to end-point (14 weeks)
Other	Children's Yale-Brown Obsessive Compulsive Scale	Assesses severity of obsessive-compulsive symptoms in the last week	Change from baseline to 3months following end-point (26 weeks)
Other	Children's Depression Inventory	Assesses depressive symptoms in children	Change from baseline to mid-point (6 weeks)
Other	Children's Depression Inventory	Assesses depressive symptoms in children	Change from baseline to end-point (14 weeks)
Other	Children's Depression Inventory	Assesses depressive symptoms in children	Change from baseline to 3months following end-point (26 weeks)
Other	Emotion Regulation Questionnaire	Measures emotion regulation strategies	Change from baseline to mid-point (6 weeks)
Other	Emotion Regulation Questionnaire	Measures emotion regulation strategies	Change from baseline to end-point (14 weeks)
Other	Emotion Regulation Questionnaire	Measures emotion regulation strategies	Change from baseline to 3months following end-point (26 weeks)
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	1 week
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	2 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	3 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	4 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	5 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	6 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	7 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	8 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	9 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	10 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	12 weeks
Other	Concomitant Medication and Therapy Questionnaire	Tracks whether there are any concurrent therapy and/or medication changes	14 weeks
Other	The Caregiver Strain Questionnaire	Assesses the extent to which the subject's condition has negatively affected the family	Change from baseline to mid-point (6 weeks)
Other	The Caregiver Strain Questionnaire	Assesses the extent to which the subject's condition has negatively affected the family	Change from baseline to end-point (14 weeks)
Other	The Caregiver Strain Questionnaire	Assesses the extent to which the subject's condition has negatively affected the family	Change from baseline to 3months following end-point (26 weeks)
Other	Child Tourette's Syndrome Impairment Scale	Assesses the impact that tics have on school, home, and social activities	Change from baseline to mid-point (6 weeks)
Other	Child Tourette's Syndrome Impairment Scale	Assesses the impact that tics have on school, home, and social activities	Change from baseline to end-point (14 weeks)
Other	Child Tourette's Syndrome Impairment Scale	Assesses the impact that tics have on school, home, and social activities	Change from baseline to 3months following end-point (26 weeks)
Primary	Patient Satisfaction Questionnaire	Scale that measures the subject's satisfaction with the treatment	26 weeks
Primary	Expectancy Therapy Evaluation Form	Rates subject's expectations about effectiveness of the treatment	Baseline
Primary	Satisfaction Scale for Module 1	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	1 week
Primary	Expectancy Therapy Evaluation Form	Rates subject's expectations about effectiveness of the treatment	6 weeks
Primary	Satisfaction Scale for Module 2	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	2 weeks
Primary	Satisfaction Scale for Module 3	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	3 weeks
Primary	Satisfaction Scale for Module 4	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	4 weeks
Primary	Satisfaction Scale for Module 5	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	5 weeks
Primary	Satisfaction Scale for Module 6	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	6 weeks
Primary	Satisfaction Scale for Module 7	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	7 weeks
Primary	Satisfaction Scale for Module 8	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	8 weeks
Primary	Satisfaction Scale for Module 9	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	9 weeks
Primary	Satisfaction Scale for Module 10	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	10 weeks
Primary	Satisfaction Scale for Module 11	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	12 weeks
Primary	Satisfaction Scale for Module 12	Brief Likert scale/multiple choice questions assessing the satisfaction/effectiveness of each session.	14 weeks
Primary	Patient Satisfaction Questionnaire	Scale that measures the patient's satisfaction with the treatment	6 weeks
Primary	Patient Satisfaction Questionnaire	Scale that measures the patient's satisfaction with the treatment	14 weeks
Secondary	Yale Global Tic Severity Scale	Measures tic symptom severity and impairment	Change from baseline to mid-point (6 weeks)
Secondary	Yale Global Tic Severity Scale	Measures tic symptom severity and impairment	Change from baseline to end-point (14 weeks)
Secondary	Yale Global Tic Severity Scale	Measures tic symptom severity and impairment	Change from baseline to 3months following end-point (26 weeks)
Secondary	Vanderbilt Assessment Scale - ADHD	Measures DSM-IV ADHD and other externalizing behaviors	Change from baseline to mid-point (6 weeks)
Secondary	Vanderbilt Assessment Scale - ADHD	Measures DSM-IV ADHD and other externalizing behaviors	Change from baseline to end-point (14 weeks)
Secondary	Vanderbilt Assessment Scale - ADHD	Measures DSM-IV ADHD and other externalizing behaviors	Change from baseline to 3months following end-point (26 weeks)
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to one week
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to one week
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to two weeks
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to two weeks
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to three weeks
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to three weeks
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to four weeks
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to four weeks
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to five weeks
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to five weeks
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to six weeks (mid-point)
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to six weeks (mid-point)
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to seven weeks
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to seven weeks
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to eight weeks
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to eight weeks
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to nine weeks
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to nine weeks
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to ten weeks
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to ten weeks
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to twelve weeks (session 11)
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to twelve weeks (session 11)
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to fourteen weeks (session 12)
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to fourteen weeks (session 12)
Secondary	Clinical Global Impression - Improvement Scale	Measures improvement on a Likert scale	Change from baseline to 3months after end-point (26 weeks)
Secondary	Clinical Global Impression - Severity Scale	Measures severity of illness on a Likert scale	Change from baseline to 3months after end-point (26 weeks)
Secondary	Pediatric Quality of Life Inventory (PedsQL)-Child Version	Assesses pediatric population subject's quality of life on a scale of 0-100, with higher scores indicating a better quality of life.	Change from baseline to mid-point (6 weeks)
Secondary	Pediatric Quality of Life Inventory (PedsQL)-Child Version	Assesses pediatric population subject's quality of life on a scale of 0-100, with higher scores indicating a better quality of life.	Change from baseline to end-point (14 weeks)
Secondary	Pediatric Quality of Life Inventory (PedsQL)-Child Version	Assesses pediatric population subject's quality of life on a scale of 0-100, with higher scores indicating a better quality of life.	Change from baseline to 3months following end-point (26 weeks)
Secondary	Parent Tic Questionnaire (PTQ)	Measures severity of specific motor and vocal tics in terms of their frequency and intensity on a scale of 1-4, with higher scores indicating greater frequency and intensity.	Mid-point (6 weeks)
Secondary	Parent Tic Questionnaire (PTQ)	Measures severity of specific motor and vocal tics in terms of their frequency and intensity on a scale of 1-4, with higher scores indicating greater frequency and intensity.	End-point (14 weeks)
Secondary	Parent Tic Questionnaire (PTQ)	Measures severity of specific motor and vocal tics in terms of their frequency and intensity on a scale of 1-4, with higher scores indicating greater frequency and intensity.	3months following end-point (26 weeks)
Secondary	ADHD - Self-report	Self-report of ADHD symptoms	Change from baseline to mid-point (6 weeks)
Secondary	ADHD - Self-report	Self-report of ADHD symptoms	Change from baseline to end-point (14 weeks)
Secondary	ADHD - Self-report	Self-report of ADHD symptoms	Change from baseline to 3months following end-point (26 weeks)