Neuropsychological Profiles of Pediatric Obsessive Compulsive Disorder (OCD)

Study Overview
=================
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.

Official Title
-----------------
Investigating the Neuropsychological Profile of Youth With Obsessive Compulsive Disorder (OCD)

Conditions
-----------------
Obsessive Compulsive Disorder (OCD)

Intervention / Treatment
-----------------
* Behavioral: CBT for pediatric OCD


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT for pediatric OCD<br>Participants complete standard CBT for OCD | Behavioral: CBT for pediatric OCD<br>* Participants complete standard CBT for OCD as delivered in the POTS study .<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline (one week prior to starting treatment) | 
| 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 | 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) | 
| 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. | 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) | 
| 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. | 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) | 
| 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 | 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) | 
| 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. | 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) | 
| 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. | 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) | 
| 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. | 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) | 
| 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 | 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) | 
| 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. | 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) | 
| 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 | 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) | 
| 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 | 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) | 
| 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. | 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) | 
| 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 | 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) | 
| 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. | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children, OCD, CBT, Neuropsychological profiles