Tourette SyndromeNCT02882490
Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome
A study testing Parent Training and Supportive Therapy in people with Tourette Syndrome and Behavioral Problem, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Tourette Syndrome, Behavioral Problem
- What is being tested?
- Parent Training and Supportive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Fulfill DSM-5 diagnostic criteria for Tourette's Disorder
- Moderate disruptive behaviors (Home Situations Questionnaire score >3)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Blanca Garcia-Delgar, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic
Barcelona, 08036
Blanca Garcia-Delgar, MD, +34 93 227 99 74
About this study
Official title: Disruptive Behaviors in Children With Tourette Syndrome: the Role of Social Cognition and Efficacy of a Parent Behavioral Training Program
This is a randomized controlled trial to assess the efficacy of a parent training program to control disruptive behaviors in children with Tourette Syndrome.
Read the 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.
- Conditions
- Tourette Syndrome, Behavioral Problem
- Being tested
- Parent Training, Supportive Therapy
- Keywords
- Tourette syndrome
- Medical subject headings
- Tourette Syndrome, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent TrainingBehavioural
Supportive TherapyOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Parent Training |
| 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. Receives: Other: Supportive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Change from baseline to week 10; 3 months follow up; 6 months follow up
Secondary outcomes (4)
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".
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Change from baseline to week 10; 3 months follow up; 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJun 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Association for Child and Adolescent Psychiatry (AEPNYA)
- Responsible party
- Principal investigator, Blanca Garcia-Delgar, Hospital Clinic of Barcelona
- Investigators
- Astrid Morer, MD, Study director, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882490
- Sponsor's protocol ID
- AEPNYA 2014-2016
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 12500082Barkley, R. A. (1999). Defiant teen: A Clinician's Manual for Assessment and Parent Training. New York: Guilford Press.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disruptive Behaviors in Children With Tourette Syndrome: the Role of Social Cognition and Efficacy of a Parent Behavioral Training Program
- ClinicalTrials.gov ID
- NCT02882490
- Acronym / sponsor ID
- AEPNYA 2014-2016
- Conditions
- Tourette Syndrome, Behavioral Problem
- Keywords
- Tourette syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- Spanish Association for Child and Adolescent Psychiatry (AEPNYA)
- Study start
- Jun 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent training (PT) | Experimental | Behavioral: Parent TrainingThe 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 | Other: Supportive TherapyThe 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Fulfill DSM-5 diagnostic criteria for Tourette's Disorder
- Moderate disruptive behaviors (Home Situations Questionnaire score >3)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent Training | Behavioural | Parent training (PT) |
| Supportive Therapy | Other | Supportive Therapy (ST) |
Primary outcome
Home Situations Questionnaire (HSQ)
Time frame: 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".
4 secondary outcomes
Alabama Parenting Questionnaire
Time frame: Change from baseline to week 10; 3 months follow up; 6 months follow up
Parent Stress Index-Short Form
Time frame: 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)
Time frame: Change from baseline to week 10; 3 months follow up; 6 months follow up
Yale Global Tic Severity Scale (YGTSS)
Time frame: Change from baseline to week 10; 3 months follow up; 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Background: PubMed 12500082Sukhodolsky 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.
- BackgroundBarkley, R. A. (1999). Defiant teen: A Clinician's Manual for Assessment and Parent Training. New York: Guilford Press.
- Individual participant dataSharing planned: No
Related trials for Tourette Syndrome
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Exploring the Role of Neuroactive Steroids in Tourette Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blanca Garcia-Delgar, MD contact
Astrid Morer, MD study director
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent Training and Supportive Therapy in people with Tourette Syndrome and Behavioral Problem, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Blanca Garcia-Delgar, MD (+34 93 227 99 74), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Home Situations Questionnaire (HSQ) (time frame: Change from baseline to week 10; 3 months follow up; 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02882490, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2016.