Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

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

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

Study Overview

• Status: Unknown
• Conditions: Tourette Syndrome; Behavioral Problem
• Intervention / Treatment: Behavioral: Parent Training; Other: Supportive Therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Blanca Garcia-Delgar, MD; Phone Number: +34 93 227 99 74

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic
    • Contact: Blanca Garcia-Delgar, MD; Phone Number: +34 93 227 99 74

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 14 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Parent training (PT); The PT arm receives a 10-week therapist-guided behavioral group treatment. The treatment is based on existing literature for training parents in child behavior management skills (Barkley 1999). Parents attend weekly sessions, which last 90 minutes and are held at the Hospital Clinic of Barcelona. Parents are given homework assignments to complete between sessions.	Behavioral: Parent Training
EXPERIMENTAL: Supportive Therapy (ST); The ST arm receives a 10-week supportive group treatment. Parents are invited to discuss relevant problems that have occurred during the previous week. A therapist moderate the discussion but does not provide information about the behavioral techniques included in the PT group. Parents attend weekly sessions, which last 90 minutes and are held at the Hospital Clinic of Barcelona. Parents are given homework assignments to complete between sessions.	Other: Supportive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Collaborators: Spanish Association for Child and Adolescent Psychiatry (AEPNYA)
• Investigators: Study Director: Astrid Morer, MD, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ANTICIPATED): June 1, 2017
• Study Completion (ANTICIPATED): June 1, 2017

Study Registration Dates

• First Submitted: August 22, 2016
• First Submitted That Met QC Criteria: August 24, 2016
• First Posted (ESTIMATE): August 29, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): August 29, 2016
• Last Update Submitted That Met QC Criteria: August 24, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Tourette syndrome
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Problem Behavior; Tourette Syndrome
• Other Study ID Numbers: AEPNYA 2014-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO