Comorbidities and Coexisting Conditions Clinical Trial
Official title:
Improving Symptom Trajectories of Tic Disorders and Co-occurring Diagnoses: The Role of Integrative Intensive Intervention
Verified date | July 2022 |
Source | Florida International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 21 |
Est. completion date | October 31, 2021 |
Est. primary completion date | September 29, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Florida International University | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida International University |
United States,
Chorpita BF, Moffitt CE, Gray J. Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample. Behav Res Ther. 2005 Mar;43(3):309-22. — View Citation
Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. — View Citation
Leckman JF, Riddle MA, Hardin MT, Ort SI, Swartz KL, Stevenson J, Cohen DJ. The Yale Global Tic Severity Scale: initial testing of a clinician-rated scale of tic severity. J Am Acad Child Adolesc Psychiatry. 1989 Jul;28(4):566-73. — View 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. — View Citation
Pelham WE Jr, Gnagy EM, Greenslade KE, Milich R. Teacher ratings of DSM-III-R symptoms for the disruptive behavior disorders. J Am Acad Child Adolesc Psychiatry. 1992 Mar;31(2):210-8. Erratum in: J Am Acad Child Adolesc Psychiatry 1992 Nov;31(6):1177. — View Citation
Pelletier, J, Collett, B, Gimpel, G, & Crowley S. Assessment of Disruptive Behaviors in Preschoolers: Psychometric Properties of the Disruptive Behavior Disorders Rating Scale and School Situations Questionnaire. Journal of Psychoeducational Assessment. 2006; 24(1): 3-18.
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Yale Global Tic Severity Scale (YGTSS) | 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. | Change from pre-treatment to post, and 1-month following the end of treatment | |
Secondary | Revised Child Anxiety and Depression Scale (RCADS) | 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)). | Change from pre-treatment to post and 1-month | |
Secondary | Disruptive Behavior Disorder Rating Scale (DBD-RS) | 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). | Change from pre-treatment to post and 1-month following the end of treatment. |
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