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Neuropsychological Profiles of Pediatric Obsessive Compulsive Disorder (OCD)

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ClinicalTrials.gov Identifier: NCT02160431
Recruitment Status : Terminated (Inadequate funding)
First Posted : June 10, 2014
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Kevin D. Stark, University of Texas at Austin

Brief Summary:
The neuropsychological profiles of children treated with standard CBT for OCD are evaluated.

Condition or disease Intervention/treatment Phase
Obsessive Compulsive Disorder (OCD) Behavioral: CBT for pediatric OCD Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Neuropsychological Profile of Youth With Obsessive Compulsive Disorder (OCD)
Study Start Date : July 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CBT for pediatric OCD
Participants complete standard CBT for OCD
Behavioral: CBT for pediatric OCD
Participants complete standard CBT for OCD as delivered in the POTS study .




Primary Outcome Measures :
  1. 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. [ 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) ]
    Measures presence and severity of obsessions and compulsions.


Secondary Outcome Measures :
  1. 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. [ Time Frame: Baseline (one week prior to starting treatment) ]
    Interview measure of the presence of OCD, related anxiety disorders and other psychological disorders of childhood.

  2. 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. [ 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) ]
    Measure of the severity of the disorders and their improvement as a result of treatment

  3. 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. [ 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) ]
    Assesses the overall general functioning of youth under the age of 18.

  4. 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. [ 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) ]
    Assessment of presence of obsessive compulsive symptoms over the past week.

  5. 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. [ 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) ]
    Neuropsychological measure of executive functioning

  6. 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. [ 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) ]
    Measure of the presence and severity of anxiety symptoms.

  7. 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. [ 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) ]
    Broadband measure of child's psychological functioning.

  8. 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. [ 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) ]
    Measure of the presence and severity of a wide range of emotional disorders.

  9. 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. [ 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) ]
    Measure of parental psychopathology

  10. 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. [ 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) ]
    Measure of the degree to which parents accommodate to their child's OCD.

  11. 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. [ 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) ]
    Neuropsychological measure of the participant's selective, divided, sustained and switching attention

  12. 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. [ 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) ]
    Neuropsychological measure of executive functioning

  13. 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. [ 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) ]
    Neuropsychological test of a variety of verbal and nonverbal executive functions.

  14. 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. [ 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) ]
    Neuropsychological test of cognitive flexibility

  15. 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. [ 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) ]
    Neuropsychological measure of continuous attention.


Other Outcome Measures:
  1. Perception of Therapeutic Relationship measures quality of therapeutic relationship at post-treatment and at one year and two year follow-up assessments. [ 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) ]
    Measure of the participant's perception of the therapeutic relationship

  2. Satisfaction Questionnaire measures satisfaction with treatment at post-treatment and at one year and two year follow-up assessments. [ 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) ]
    Measures the patient's satisfaction with treatment.



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Ages Eligible for Study:   8 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160431


Locations
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United States, Texas
Texas Child Study Center
Austin, Texas, United States, 78731
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Kevin D. Stark, Ph.D. University of Texas
Additional Information:
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Responsible Party: Kevin D. Stark, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT02160431    
Other Study ID Numbers: 2013-004-0024
First Posted: June 10, 2014    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016
Keywords provided by Kevin D. Stark, University of Texas at Austin:
Children
OCD
CBT
Neuropsychological profiles
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders