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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02160431
Other study ID # 2013-004-0024
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 15, 2013
Last updated June 29, 2014
Start date July 2014
Est. completion date July 2016

Study information

Verified date June 2014
Source University of Texas at Austin
Contact Kevin D. Stark, Ph.D.
Phone 512-324-3315
Email kstark@austin.utexas.edu
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 25
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 16 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
CBT for pediatric OCD
Participants complete standard CBT for OCD as delivered in the POTS study .

Locations

Country Name City State
United States Texas Child Study Center Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Perception of Therapeutic Relationship measures quality of therapeutic relationship at post-treatment and at one year and two year follow-up assessments. Measure of the participant's perception of the therapeutic relationship 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) No
Other Satisfaction Questionnaire measures satisfaction with treatment at post-treatment and at one year and two year follow-up assessments. Measures the patient's satisfaction with 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) No
Primary 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) No
Secondary 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) Yes
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
Secondary 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) No
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