Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

Sponsor
Hospital Clinic of Barcelona (Other)
Overall Status
Unknown status
CT.gov ID
NCT02882490
Collaborator
Spanish Association for Child and Adolescent Psychiatry (AEPNYA) (Other)
42
1
2
36
1.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Parent Training
  • Other: Supportive Therapy
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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
Study Start Date :
Jun 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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".

  2. 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.

  3. 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.

  4. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 14 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinic Barcelona Spain 08036

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Blanca Garcia-Delgar, M.D., Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT02882490
Other Study ID Numbers:
  • AEPNYA 2014-2016
First Posted:
Aug 29, 2016
Last Update Posted:
Aug 29, 2016
Last Verified:
Aug 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Blanca Garcia-Delgar, M.D., Hospital Clinic of Barcelona
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 29, 2016