Clinical trial NCT02882490: Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome
Official title: Disruptive Behaviors in Children With Tourette Syndrome: the Role of Social Cognition and Efficacy of a Parent Behavioral Training Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tourette Syndrome
Behavioral Problem
Keywords: Tourette syndrome
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Spanish Association for Child and Adolescent Psychiatry (AEPNYA)
First posted: 2016-08-29
Enrollment: 42
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial to assess the efficacy of a parent training program to control disruptive behaviors in children with Tourette Syndrome.

Detailed description: Disruptive behaviors occur in 80% of children with Tourette Syndrome, and can be more disabling than the tics themselves.

The aim of this study is to assess the efficacy of a parent training program to control disruptive behaviors in children with Tourette Syndrome. In addition, social cognition will be examined in all the participants to analyze its relationship with the severity of disruptive behavior and the treatment response.

42 children with Tourette Syndrome and moderate disruptive behaviors will be randomly assigned to a 10-week Parent Training Program or a 10-week Supportive Therapy. Clinical response will be evaluated after the intervention period, and three and six months later.

Eligibility criteria: Inclusion Criteria:

* Fulfill DSM-5 diagnostic criteria for Tourette's Disorder
* Moderate disruptive behaviors (Home Situations Questionnaire score \>3)

Exclusion Criteria:

* Lifetime history of global learning disability, autism spectrum disorder, psychosis, bipolar disorder or organic brain disorder.
* Previous parent training with qualified therapist within the last 12 months prior to assessment
* Simultaneous individual treatment for disruptive behaviors.
* Initiation or adjustment of any psychotropic medication within the last 6 weeks prior to assessment

Primary outcomes:
measure: Home Situations Questionnaire (HSQ)
timeFrame: Change from baseline to week 10; 3 months follow up; 6 months follow up
Secondary outcomes:
measure: Alabama Parenting Questionnaire
timeFrame: Change from baseline to week 10; 3 months follow up; 6 months follow up
measure: Parent Stress Index-Short Form
timeFrame: Change from baseline to week 10; 3 months follow up; 6 months follow up
measure: The Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOF)
timeFrame: Change from baseline to week 10; 3 months follow up; 6 months follow up
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Change from baseline to week 10; 3 months follow up; 6 months follow up
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Astrid Morer, MD
role: STUDY_DIRECTOR
References:
citation: Sukhodolsky DG, Scahill L, Zhang H, Peterson BS, King RA, Lombroso PJ, Katsovich L, Findley D, Leckman JF. Disruptive behavior in children with Tourette's syndrome: association with ADHD comorbidity, tic severity, and functional impairment. J Am Acad Child Adolesc Psychiatry. 2003 Jan;42(1):98-105. doi: 10.1097/00004583-200301000-00016.
citation: Barkley, R. A. (1999). Defiant teen: A Clinician's Manual for Assessment and Parent Training. New York: Guilford Press.