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Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

Primary Purpose

Tourette Syndrome, Behavioral Problem

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Parent Training
Supportive Therapy
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette syndrome

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Parent training (PT)

Supportive Therapy (ST)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

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".
Parent Stress Index-Short Form
Parent-rated scale with 36-items questionnaire designed to measure stress in parent-child relationship.
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.
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).

Full Information

First Posted
August 22, 2016
Last Updated
August 24, 2016
Sponsor
Hospital Clinic of Barcelona
Collaborators
Spanish Association for Child and Adolescent Psychiatry (AEPNYA)
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1. Study Identification

Unique Protocol Identification Number
NCT02882490
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
Spanish Association for Child and Adolescent Psychiatry (AEPNYA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Behavioral Problem
Keywords
Tourette syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parent training (PT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Supportive Therapy (ST)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Parent Training
Intervention Type
Other
Intervention Name(s)
Supportive Therapy
Primary Outcome Measure Information:
Title
Home Situations Questionnaire (HSQ)
Description
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".
Time Frame
Change from baseline to week 10; 3 months follow up; 6 months follow up
Secondary Outcome Measure Information:
Title
Alabama Parenting Questionnaire
Description
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".
Time Frame
Change from baseline to week 10; 3 months follow up; 6 months follow up
Title
Parent Stress Index-Short Form
Description
Parent-rated scale with 36-items questionnaire designed to measure stress in parent-child relationship.
Time Frame
Change from baseline to week 10; 3 months follow up; 6 months follow up
Title
The Gilles de la Tourette Syndrome-Quality of Life Scale (GTS-QOF)
Description
Patient-reported scale with 27-items designed to measure health-related quality of life in children and adolescents with Tourette Syndrome.
Time Frame
Change from baseline to week 10; 3 months follow up; 6 months follow up
Title
Yale Global Tic Severity Scale (YGTSS)
Description
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).
Time Frame
Change from baseline to week 10; 3 months follow up; 6 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Blanca Garcia-Delgar, MD
Phone
+34 93 227 99 74
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Astrid Morer, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanca Garcia-Delgar, MD
Phone
+34 93 227 99 74

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12500082
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.
Results Reference
background
Citation
Barkley, R. A. (1999). Defiant teen: A Clinician's Manual for Assessment and Parent Training. New York: Guilford Press.
Results Reference
background

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Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

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