Parent Behavioral Training for Disruptive Behaviors in Tourette Syndrome

NCT ID: NCT02882490

Last Updated: 2016-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-06-30

Brief Summary

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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

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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

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Tourette Syndrome Behavioral Problem

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Parent Training

Intervention Type BEHAVIORAL

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.

Group Type EXPERIMENTAL

Supportive Therapy

Intervention Type OTHER

Interventions

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Parent Training

Intervention Type BEHAVIORAL

Supportive Therapy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Spanish Association for Child and Adolescent Psychiatry (AEPNYA)

UNKNOWN

Sponsor Role collaborator

Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Blanca Garcia-Delgar

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Astrid Morer, MD

Role: STUDY_DIRECTOR

Hospital Clinic of Barcelona

Locations

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Hospital Clinic

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Blanca Garcia-Delgar, MD

Role: CONTACT

+34 93 227 99 74

Facility Contacts

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Blanca Garcia-Delgar, MD

Role: primary

+34 93 227 99 74

References

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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.

Reference Type BACKGROUND
PMID: 12500082 (View on PubMed)

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

Reference Type BACKGROUND

Other Identifiers

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AEPNYA 2014-2016

Identifier Type: -

Identifier Source: org_study_id

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