Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Tourette Syndrome, Behavioral Problem

Intervention / Treatment
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* Behavioral: Parent Training
* Other: Supportive Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parent training (PT)<br>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<br> <br> |
| Experimental: Supportive Therapy (ST)<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tourette syndrome