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Neuropsychological Profiles of Pediatric Obsessive Compulsive Disorder (OCD)

Primary Purpose

Obsessive Compulsive Disorder (OCD)

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT for pediatric OCD
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive Compulsive Disorder (OCD) focused on measuring Children, OCD, CBT, Neuropsychological profiles

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children 8-16 years old who have a primary diagnosis of Obsessive Compulsive Disorder

Exclusion Criteria:

  • Risk of suicidal or homicidal behavior
  • Presence of another psychological disorder as the primary disorder
  • Psychotic disorder, bipolar disorder, Pervasive Developmental Disorder, Thought Disorder, Uncontrolled ADHD, Eating Disorder, Substance Use Disorders, School refusal behavior characterized by missing more than 25% of days in most recent term, does not speak English, youth does not have at least one parent who speaks English

Sites / Locations

  • Texas Child Study Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CBT for pediatric OCD

Arm Description

Participants complete standard CBT for OCD

Outcomes

Primary Outcome Measures

Children's Yale Brown Obsessive Compulsive Scale measures change in severity of OCD symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Measures presence and severity of obsessions and compulsions.

Secondary Outcome Measures

Anxiety Disorders Interview Schedule-Diagnostic and Statistical Manual-IV measures change in severity of OCD symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Interview measure of the presence of OCD, related anxiety disorders and other psychological disorders of childhood.
Clinical Global Impression Severity and Improvement Scales measures change in severity of OCD and co-morbid disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Measure of the severity of the disorders and their improvement as a result of treatment
Global Assessment Scale for Children measures change in overall functioning from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Assesses the overall general functioning of youth under the age of 18.
Child Obsessive-Compulsive Inventory measures change in severity of OCD symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Assessment of presence of obsessive compulsive symptoms over the past week.
Behavior Rating Inventory of Executive Function measures change in executive functioning from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Neuropsychological measure of executive functioning
Multidimensional Anxiety Scale for Children measures change in severity of anxiety symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Measure of the presence and severity of anxiety symptoms.
Child Behavior Checklist measures change in severity internalizing and externalizing symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Broadband measure of child's psychological functioning.
Screen for Child Anxiety and Related Emotional Disorders measures change in severity of anxiety and other disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Measure of the presence and severity of a wide range of emotional disorders.
Brief Symptom Interview measures change in severity of parental psychopathology from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Measure of parental psychopathology
Family Accommodation Scale measures change in parental accommodation from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Measure of the degree to which parents accommodate to their child's OCD.
Test of Everyday Attention-Children's Version measures change in attention from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Neuropsychological measure of the participant's selective, divided, sustained and switching attention
Wisconsin Card Sorting Test Revised and Expanded measures change in executive functioning from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Neuropsychological measure of executive functioning
Delis-Kaplan Executive Function System measures change in executive functioning from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Neuropsychological test of a variety of verbal and nonverbal executive functions.
Children's Color Trails Test measures change in cognitive flexibility from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Neuropsychological test of cognitive flexibility
The Conners' Continuous Performance Test II Version 5measures change in continuous attention from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Neuropsychological measure of continuous attention.

Full Information

First Posted
July 15, 2013
Last Updated
May 10, 2016
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT02160431
Brief Title
Neuropsychological Profiles of Pediatric Obsessive Compulsive Disorder (OCD)
Official Title
Investigating the Neuropsychological Profile of Youth With Obsessive Compulsive Disorder (OCD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Terminated
Why Stopped
Inadequate funding
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The neuropsychological profiles of children treated with standard CBT for OCD are evaluated.
Detailed Description
The neuropsychological profiles of children treated with standard CBT for the treatment of OCD will be compared at pre-treatment and post-treatment. Children between the ages of 8 and 16 years who have a primary diagnosis of OCD will be participants. Treatment will last 12 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder (OCD)
Keywords
Children, OCD, CBT, Neuropsychological profiles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT for pediatric OCD
Arm Type
Experimental
Arm Description
Participants complete standard CBT for OCD
Intervention Type
Behavioral
Intervention Name(s)
CBT for pediatric OCD
Intervention Description
Participants complete standard CBT for OCD as delivered in the POTS study .
Primary Outcome Measure Information:
Title
Children's Yale Brown Obsessive Compulsive Scale measures change in severity of OCD symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Measures presence and severity of obsessions and compulsions.
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Secondary Outcome Measure Information:
Title
Anxiety Disorders Interview Schedule-Diagnostic and Statistical Manual-IV measures change in severity of OCD symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Interview measure of the presence of OCD, related anxiety disorders and other psychological disorders of childhood.
Time Frame
Baseline (one week prior to starting treatment)
Title
Clinical Global Impression Severity and Improvement Scales measures change in severity of OCD and co-morbid disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Measure of the severity of the disorders and their improvement as a result of treatment
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Global Assessment Scale for Children measures change in overall functioning from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Assesses the overall general functioning of youth under the age of 18.
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Child Obsessive-Compulsive Inventory measures change in severity of OCD symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Assessment of presence of obsessive compulsive symptoms over the past week.
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Behavior Rating Inventory of Executive Function measures change in executive functioning from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Neuropsychological measure of executive functioning
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Multidimensional Anxiety Scale for Children measures change in severity of anxiety symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Measure of the presence and severity of anxiety symptoms.
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Child Behavior Checklist measures change in severity internalizing and externalizing symptoms from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Broadband measure of child's psychological functioning.
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Screen for Child Anxiety and Related Emotional Disorders measures change in severity of anxiety and other disorders from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Measure of the presence and severity of a wide range of emotional disorders.
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Brief Symptom Interview measures change in severity of parental psychopathology from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Measure of parental psychopathology
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Family Accommodation Scale measures change in parental accommodation from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Measure of the degree to which parents accommodate to their child's OCD.
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Test of Everyday Attention-Children's Version measures change in attention from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Neuropsychological measure of the participant's selective, divided, sustained and switching attention
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Wisconsin Card Sorting Test Revised and Expanded measures change in executive functioning from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Neuropsychological measure of executive functioning
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Delis-Kaplan Executive Function System measures change in executive functioning from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Neuropsychological test of a variety of verbal and nonverbal executive functions.
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Children's Color Trails Test measures change in cognitive flexibility from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Neuropsychological test of cognitive flexibility
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
The Conners' Continuous Performance Test II Version 5measures change in continuous attention from baseline to post-treatment and assesses maintenance of treatment effects at one year and two year follow-up assessments.
Description
Neuropsychological measure of continuous attention.
Time Frame
Baseline (one week prior to start of treatment, post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Other Pre-specified Outcome Measures:
Title
Perception of Therapeutic Relationship measures quality of therapeutic relationship at post-treatment and at one year and two year follow-up assessments.
Description
Measure of the participant's perception of the therapeutic relationship
Time Frame
Post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)
Title
Satisfaction Questionnaire measures satisfaction with treatment at post-treatment and at one year and two year follow-up assessments.
Description
Measures the patient's satisfaction with treatment.
Time Frame
Post treatment (within one week of completing treatment) and follow-ups (six months, and at one year intervals for up to two years following treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children 8-16 years old who have a primary diagnosis of Obsessive Compulsive Disorder Exclusion Criteria: Risk of suicidal or homicidal behavior Presence of another psychological disorder as the primary disorder Psychotic disorder, bipolar disorder, Pervasive Developmental Disorder, Thought Disorder, Uncontrolled ADHD, Eating Disorder, Substance Use Disorders, School refusal behavior characterized by missing more than 25% of days in most recent term, does not speak English, youth does not have at least one parent who speaks English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin D. Stark, Ph.D.
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Child Study Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.dellchildrens.net/services_and_programs/texas_child_study_center__mental_health_services/
Description
Texas Child Study Center

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Neuropsychological Profiles of Pediatric Obsessive Compulsive Disorder (OCD)

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