NCT02160431

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2013

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
21 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

Same day

First QC Date

July 15, 2013

Last Update Submit

May 10, 2016

Conditions

Keywords

ChildrenOCDCBTNeuropsychological profiles

Outcome Measures

Primary Outcomes (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.

    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 Outcomes (15)

  • 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.

    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.

    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.

    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.

    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.

    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)

  • +10 more secondary outcomes

Other Outcomes (2)

  • Perception of Therapeutic Relationship measures quality of therapeutic relationship at post-treatment and at one year and two year follow-up assessments.

    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)

  • Satisfaction Questionnaire measures satisfaction with treatment at post-treatment and at one year and two year follow-up assessments.

    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)

Study Arms (1)

CBT for pediatric OCD

EXPERIMENTAL

Participants complete standard CBT for OCD

Behavioral: CBT for pediatric OCD

Interventions

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

CBT for pediatric OCD

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Child Study Center

Austin, Texas, 78731, United States

Location

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Kevin D. Stark, Ph.D.

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 15, 2013

First Posted

June 10, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations