Florida International University
Miami, Florida, 33199, United States
NCT Number: NCT04878302
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.
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Notify Me7 year–17 year
All sexes
Interventional
Not applicable
Miami, Florida, 33199, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Families assigned to the immediate treatment group will receive the telehealth-based Taming Tics Together protocol(created using well-established, evidence-based treatment protocols), which includes group (parent/caregiver-only, child/teen-only) and individualized one-to-one sessions to address tics and co-occurring diagnoses.
Time frame: Change from pre-treatment to post, and 1-month following the end of treatment
Yale Global Tic Severity Scale (Leckman et al., 1989). The Yale Global Tic Severity Scale is a clinician-administered assessment evaluating tic history, as well as tics present over the past 7-10 days. The Yale Global Tic Severity Scale has been used in several randomized controlled trials and has exhibited excellent internal consistency (i.e., McGuire et al., 2018). Motor and vocal tics are rated based on their number, frequency, intensity, complexity and interference (each rated on a scale from 0-5), and impairment (rated on a scale from 0-50). The Total Tic Severity Score evaluates overall motor and vocal tic severity (range 0-50), and the Total Yale Global Tic Severity Scale Score evaluates the total tic severity score in additional to impairment, with a range of scores from 0 to 100. Higher scores indicate increased severity.
Time frame: Change from pre-treatment to post and 1-month
Revised Child Anxiety and Depression Scale (RCADS; Chorpita et al., 2000). The RCADS is a 47-item self-report measure to evaluate several internalizing domains. Items are rated on a scale from 0 (never) to 3 (always). The RCADS has demonstrated high internal consistency (Chorpita, Moffit, & Gray, 2005)).
Time frame: Change from pre-treatment to post and 1-month following the end of treatment.
Disruptive Behavior Disorder Rating Scale (DBD-RS; Pelham et al.,1992). The DBD-RS is a 45-item parent rating scale to assess for disruptive behaviors, specifically, ADHD, oppositional defiant disorder, and conduct disorder. Informants complete the rating scale using a four-point Likert scale (zero = not at all; one = just a little; two = pretty much; three = very much). The DBD-RS has demonstrated high internal consistency (Pelletier et al., 2006).
Florida International University
Other
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