Behavioral Problem, Tourette Syndrome
Conditions
Keywords
Tourette syndrome
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.
Interventions
BEHAVIORALParent Training
OTHERSupportive Therapy
Sponsors
Spanish Association for Child and Adolescent Psychiatry (AEPNYA)
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Home Situations Questionnaire (HSQ) | Change from baseline to week 10; 3 months follow up; 6 months follow up | 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
| Measure | Time frame | Description |
|---|---|---|
| Alabama Parenting Questionnaire | Change from baseline to week 10; 3 months follow up; 6 months follow up | 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 | Change from baseline to week 10; 3 months follow up; 6 months follow up | 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) | Change from baseline to week 10; 3 months follow up; 6 months follow up | 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) | Change from baseline to week 10; 3 months follow up; 6 months follow up | 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). |
Countries
Spain
Contacts
Primary ContactBlanca Garcia-Delgar, MD
Outcome results
None listed