Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

Disruptive Behaviors in Children With Tourette Syndrome: the Role of Social Cognition and Efficacy of a Parent Behavioral Training Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02882490
• Other study ID #: AEPNYA 2014-2016
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2016
• Last updated: August 24, 2016
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2016
• Source: Hospital Clinic of Barcelona
• Contact: Blanca Garcia-Delgar, MD
• Phone: +34 93 227 99 74
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Behavioral Problem
• Problem Behavior
• Syndrome
• Tourette Syndrome

Intervention

Behavioral:
• Parent Training

Other:
• Supportive Therapy

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	Spanish Association for Child and Adolescent Psychiatry (AEPNYA)

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Barkley, R. A. (1999). Defiant teen: A Clinician's Manual for Assessment and Parent Training. New York: Guilford Press.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Home Situations Questionnaire (HSQ)	Parent-rated scale with 16 items designed to assess behavioral non-compliance in regular home situations. Each item is rated on a 9-point Likert-type scale ranging from 1= "mild" to 9= "severe".	Change from baseline to week 10; 3 months follow up; 6 months follow up	No
Secondary	Alabama Parenting Questionnaire	42-item clinical-administered questionnaire designed to measure the following dimensions of parenting style: 1- Positive involvement with children, 2- Supervision and monitoring, 3- Use of positive discipline technique, 4- Consistency in the use of such discipline and 5- Use of corporal punishment. Each item is scored on a 5-point, Likert-type scale from 1="never" to 5 = "always".	Change from baseline to week 10; 3 months follow up; 6 months follow up	No
Secondary	Parent Stress Index-Short Form	Parent-rated scale with 36-items questionnaire designed to measure stress in parent-child relationship.	Change from baseline to week 10; 3 months follow up; 6 months follow up	No
Secondary	The Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOF)	Patient-reported scale with 27-items designed to measure health-related quality of life in children and adolescents with Tourette Syndrome.	Change from baseline to week 10; 3 months follow up; 6 months follow up	No
Secondary	Yale Global Tic Severity Scale (YGTSS)	Semi-structured interview to measure tic severity. After an initial inventory of current and lifetime motor and phonic tic types, current tic number, frequency, intensity, complexity and interference are rated on a 6-point scale. Maximum score is 100, resulting from three subscales: motor tic severity (maximum score 25), phonic tic severity (maximum score 25) and general impairment due to tics (maximum score 50).	Change from baseline to week 10; 3 months follow up; 6 months follow up	No