Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Spanish Association for Child and Adolescent Psychiatry (AEPNYA) | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized controlled trial to assess the efficacy of a parent training program to control disruptive behaviors in children with Tourette Syndrome.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parent training (PT) | Experimental | 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. |
|
| Supportive Therapy (ST) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Parent Training | Behavioral |
| ||
| Supportive Therapy |
| 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 |
| 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". |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Blanca Garcia-Delgar, MD | Contact | +34 93 227 99 74 |
| Name | Affiliation | Role |
|---|---|---|
| Astrid Morer, MD | Hospital Clinic of Barcelona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Recruiting | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12500082 | Background | 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. | |
| Background | Barkley, R. A. (1999). Defiant teen: A Clinician's Manual for Assessment and Parent Training. New York: Guilford Press. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D000066553 | Problem Behavior |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D002652 | Child Behavior |