Clinical trial NCT04878302: Improving Symptom Trajectories of Tic Disorders and Co-occurring Diagnoses: The Role of Integrative Intensive Intervention
Official title: Improving Symptom Trajectories of Tic Disorders and Co-occurring Diagnoses: The Role of Integrative Intensive Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tic Disorder, Childhood
Comorbidities and Coexisting Conditions
Lead sponsor: Florida International University
Sponsor class: OTHER
First posted: 2021-05-07
Enrollment: 21
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible families will be randomly assigned to an immediate treatment group or a 1-month waitlist.
Primary purpose: TREATMENT

Brief summary: The purpose to the current study was to examine the efficacy of a telehealth, group-based, combined and intensive intervention for youth with tic disorders (TDs) and common co-occurring diagnoses. Families seeking treatment for TDs and common co-occurring diagnoses will be randomly assigned to receive treatment immediate (enrollment in the next group) or remain on a 1-month waitlist, and then receive treatment. Outcomes will be assessed across the treatment phase, immediately following treatment (post), as well as 1-month following the end of treatment.

Detailed description: Over 1,000,000 children in the U.S. have a tic disorder (TD). TDs can substantially impact daily child functioning across numerous domains leading to a significant public health impact of TDs. Additionally, an overwhelming majority of children with a TD have at least one co-occurring disorder. Over 60% also meet criteria for attention deficit/hyperactivity disorder (ADHD), half struggle with anxiety and at least a third have clinically elevated Obsessive Compulsive-spectrum symptoms.

Comprehensive Behavioral Intervention for Tics (CBIT) is a first-line treatment for youth with TDs. It has been shown to be effective in reducing the frequency, duration, and severity of tics in children and adolescents. Nonetheless, access to trained CBIT providers remains limited, and common comorbid conditions are not addressed in standard CBIT. Thus, there is a desperate need for interventions that can simultaneously increase CBIT access and incorporate treatment strategies for comorbidities.

Intensive, group-based interventions are well-established for the treatment of comorbid disorders and have been shown to be a cost-efficient modality for delivering multimodal interventions. Intensive formats provide the opportunity for families to gain access to treatment for a limited time without the extended burden often associated with weekly treatment sessions. Further, intensive group-based treatments can simultaneously treat comorbidities.

To address the critical need for increasing access to CBIT and simultaneously treating common comorbidities, a week-long group-based intensive intervention for children with TDs and common co-occurring diagnoses (Taming Tics Together) has been developed and will be evaluated. Participants will be randomly assigned to immediate treatment or a 1-month waitlist control. Assessments will take place pre-treatment, daily throughout the intervention, as well as at 1-month post treatment.

The primary aims of the current study are to evaluate symptom reduction in tic severity and co-occurring condition symptom severity. Importantly, the investigators seek to learn more about the effectiveness of an intensive-format for tics and co-occurring diagnoses, which may lead to mechanisms to improve access to care for families who often are not able to access effective treatment.

Eligibility criteria: Inclusion Criteria:

* Youth participants are between seven and 17 years old
* Meet diagnostic criteria for a primary or co-primary diagnosis of a Tic Disorder
* Are available to participate in all sessions
* Are comfortable in English
* Youth participants have at least borderline clinician symptoms of ADHD, oppositional defiant disorder (ODD), obsessive compulsive disorder (OCD) and/or an anxiety disorder.

Exclusion Criteria:

* Are identified as having a psychiatric condition that is more impairing and requiring treatment prior to a tic intervention.
* Meet criteria for Autism Spectrum Disorder.

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Change from pre-treatment to post, and 1-month following the end of treatment
Secondary outcomes:
measure: Revised Child Anxiety and Depression Scale (RCADS)
timeFrame: Change from pre-treatment to post and 1-month
measure: Disruptive Behavior Disorder Rating Scale (DBD-RS)
timeFrame: Change from pre-treatment to post and 1-month following the end of treatment.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
References:
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citation: Woods, D, Piacentini, J, Chang, S, Deckersbach, T, Ginsburg, G, Peterson, A, Scahill, L, Walkup, J, & Wilhelm, S. Managing Tourette Syndrome: A Behavioral Intervention for Children and Adults Therapist Guide. 2008; New York, NY: Oxford University Press.
citation: McGuire JF, Piacentini J, Storch EA, Murphy TK, Ricketts EJ, Woods DW, Walkup JW, Peterson AL, Wilhelm S, Lewin AB, McCracken JT, Leckman JF, Scahill L. A multicenter examination and strategic revisions of the Yale Global Tic Severity Scale. Neurology. 2018 May 8;90(19):e1711-e1719. doi: 10.1212/WNL.0000000000005474. Epub 2018 Apr 13.