Obsessive Compulsive Disorder (OCD)NCT02160431
Neuropsychological Profiles of Pediatric Obsessive Compulsive Disorder (OCD)
A study testing CBT for pediatric OCD in people with Obsessive Compulsive Disorder (OCD), run by University of Texas at Austin at 1 site in United States.
Trial summary
The neuropsychological profiles of children treated with standard CBT for OCD are evaluated. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Obsessive Compulsive Disorder (OCD)
- What is being tested?
- CBT for pediatric OCD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 8-16 years old who have a primary diagnosis of Obsessive Compulsive Disorder
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Neuropsychological Profile of Youth With Obsessive Compulsive Disorder (OCD)
The neuropsychological profiles of children treated with standard CBT for OCD are evaluated.
Read the 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.
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Being tested
- CBT for pediatric OCD
- Keywords
- Children, OCD, CBT, Neuropsychological profiles
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for pediatric OCDBehavioural
Participants complete standard CBT for OCD as delivered in the POTS study .
| Study group | Role | What they receive |
|---|---|---|
| CBT for pediatric OCD | Experimental | Participants complete standard CBT for OCD Receives: Behavioral: CBT for pediatric OCD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Interview measure of the presence of OCD, related anxiety disorders and other psychological disorders of childhood.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Inadequate funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive Disorder (OCD)Studies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin D. Stark, University of Texas at Austin
- Investigators
- Kevin D. Stark, Ph.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160431
- Sponsor's protocol ID
- 2013-004-0024
- Status last verified
- May 2016
- First submitted
- 15 Jul 2013
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neuropsychological Profile of Youth With Obsessive Compulsive Disorder (OCD)
- ClinicalTrials.gov ID
- NCT02160431
- Acronym / sponsor ID
- 2013-004-0024
- Conditions
- Obsessive Compulsive Disorder (OCD)
- Keywords
- Children, OCD, CBT, Neuropsychological profiles
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT for pediatric OCD | Experimental | Behavioral: CBT for pediatric OCDParticipants complete standard CBT for OCD |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children 8-16 years old who have a primary diagnosis of Obsessive Compulsive Disorder
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT for pediatric OCDParticipants complete standard CBT for OCD as delivered in the POTS study . | Behavioural | CBT for pediatric OCD |
Primary outcome
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.
15 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study was stopped early (reason given: Inadequate funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin D. Stark, Ph.D. principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for pediatric OCD in people with Obsessive Compulsive Disorder (OCD), run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.