Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

NCT02882490 | Unknown

• 1 other identifier: AEPNYA 2014-2016
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome; Behavioral Problem

Keywords

Tourette syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Alabama Parenting Questionnaire

  Change from baseline to week 10; 3 months follow up; 6 months follow up

• Parent Stress Index-Short Form

  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)

  Change from baseline to week 10; 3 months follow up; 6 months follow up

• Yale Global Tic Severity Scale (YGTSS)

  Change from baseline to week 10; 3 months follow up; 6 months follow up

Study Arms (2)

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.

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.

Other: Supportive Therapy

Interventions

Parent Training BEHAVIORAL

Parent training (PT)

Supportive Therapy OTHER

Supportive Therapy (ST)

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Fulfill DSM-5 diagnostic criteria for Tourette's Disorder
• Moderate disruptive behaviors (Home Situations Questionnaire score \>3)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• Spanish Association for Child and Adolescent Psychiatry (AEPNYA): collaborator

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 12500082 BACKGROUND

• Barkley, R. A. (1999). Defiant teen: A Clinician's Manual for Assessment and Parent Training. New York: Guilford Press.

  BACKGROUND

MeSH Terms

Conditions

Tourette Syndrome; Problem Behavior

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Child Behavior

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Astrid Morer, MD

  Hospital Clinic of Barcelona

  STUDY DIRECTOR

Central Study Contacts

Blanca Garcia-Delgar, MD

CONTACT

+34 93 227 99 74

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: August 29, 2016
• Study Start: June 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 29, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)