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Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Hospital Clinic of Barcelona
Sponsor:
Collaborator:
Spanish Association for Child and Adolescent Psychiatry (AEPNYA)
Information provided by (Responsible Party):
Blanca Garcia-Delgar, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT02882490
First received: August 22, 2016
Last updated: August 24, 2016
Last verified: August 2016
  Purpose
This is a randomized controlled trial to assess the efficacy of a parent training program to control disruptive behaviors in children with Tourette Syndrome.

Condition Intervention
Tourette Syndrome
Behavioral Problem
Behavioral: Parent Training
Other: Supportive Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Disruptive Behaviors in Children With Tourette Syndrome: the Role of Social Cognition and Efficacy of a Parent Behavioral Training Program

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Home Situations Questionnaire (HSQ) [ Time Frame: Change from baseline to week 10; 3 months follow up; 6 months follow up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline to week 10; 3 months follow up; 6 months follow up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline to week 10; 3 months follow up; 6 months follow up ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change from baseline to week 10; 3 months follow up; 6 months follow up ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change from baseline to week 10; 3 months follow up; 6 months follow up ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 42
Study Start Date: June 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   8 Years to 14 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02882490

Contacts
Contact: Blanca Garcia-Delgar, MD +34 93 227 99 74

Locations
Spain
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Contact: Blanca Garcia-Delgar, MD    +34 93 227 99 74      
Sponsors and Collaborators
Hospital Clinic of Barcelona
Spanish Association for Child and Adolescent Psychiatry (AEPNYA)
Investigators
Study Director: Astrid Morer, MD Hospital Clinic of Barcelona
  More Information

Publications:
Responsible Party: Blanca Garcia-Delgar, M.D., Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02882490     History of Changes
Other Study ID Numbers: AEPNYA 2014-2016 
Study First Received: August 22, 2016
Last Updated: August 24, 2016
Health Authority: Spain: Ethics Committee
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Hospital Clinic of Barcelona:
Tourette syndrome

Additional relevant MeSH terms:
Tourette Syndrome
Problem Behavior
Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Behavioral Symptoms
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2016