Improving Symptom Trajectories of Tic Disorders and Co-occurring Diagnoses: The Role of Integrative Intensive Intervention

NCT04878302 | Completed

• 1 other identifier: IRB-20-0562
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Tic Disorder, Childhood; Comorbidities and Coexisting Conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Revised Child Anxiety and Depression Scale (RCADS)

  Change from pre-treatment to post and 1-month

• Disruptive Behavior Disorder Rating Scale (DBD-RS)

  Change from pre-treatment to post and 1-month following the end of treatment.

Study Arms (2)

Experimental: Taming Tics Together Protocol

EXPERIMENTAL

Families will participate in the 5-day telehealth-based intensive intervention and will receive three treatment formats which will provide CBIT and co-occurring diagnosis treatment: 1. Child/teen-only groups 2. Individual one-to-one sessions 3. Parent/caregiver-only groups

Behavioral: Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training)

1-Month Waitlist Control

NO INTERVENTION

Families in the 1-month waitlist control group will participate in the initial intake assessment, then receive no treatment for a 1-month period. Following the 1-month period, families will participate in an assessment, then will be offered a place in a Taming Tics Together group

Interventions

Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training) BEHAVIORAL

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.

Experimental: Taming Tics Together Protocol

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florida International University: lead

Study Sites (1)

Florida International University

Miami, Florida, 33199, United States

Location

Related Publications (7)

• 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. doi: 10.1097/00004583-198907000-00015.

  PMID: 2768151 BACKGROUND

• 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. doi: 10.1097/00004583-199203000-00006.

  PMID: 1564021 BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1016/j.brat.2004.02.004.

  PMID: 15680928 BACKGROUND

• 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. doi: 10.1016/s0005-7967(99)00130-8.

  PMID: 10937431 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 29653992 BACKGROUND

MeSH Terms

Conditions

Tic Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Independent evaluators assessing outcomes are kept unaware of the specific treatment condition and pre-treatment assessment scores.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible families will be randomly assigned to an immediate treatment group or a 1-month waitlist.

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: March 26, 2021
• Primary Completion: September 29, 2021
• Study Completion: October 31, 2021
• Last Updated: July 15, 2022

Record last verified: 2022-07

Locations

US (1)