Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series (AMPOCD)
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Attention Modification Program
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring OCD, obsessive compulsive disorder, children
Eligibility Criteria
Inclusion Criteria:
- Youth ages 8 - 17
- Primary DSM-IV diagnosis of OCD as determined by Anxiety Disorders Interview Schedule (ADIS-IV) Child/Parent version
- Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) score > 15
- Medication free or on stable medication for six weeks prior to study entry
- Informed parental consent and child assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.
Exclusion Criteria:
- DSM-IV depressive disorder, bipolar disorder, PTSD, substance abuse/dependence, conduct disorder, PDD, schizophrenia, or mental retardation
- Concurrent psychosocial treatment for OCD
- IQ < 80
- Youngsters with other comorbid disorders (e.g., anxiety, ADHD, ODD, tic disorder) will be eligible as long as these disorders are secondary to OCD in terms of severity and impairment and do not require immediate treatment initiation.
Sites / Locations
- University of California Los Angeles
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Attention Modification Program
Arm Description
Attention Modification Program
Outcomes
Primary Outcome Measures
Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment
Secondary Outcome Measures
Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment
Attention Bias Assessment Change from Pre-Treatment to Post-Treatment
Computerized assessment of attention bias
Full Information
NCT ID
NCT01708226
First Posted
October 11, 2012
Last Updated
January 13, 2017
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01708226
Brief Title
Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series
Acronym
AMPOCD
Official Title
Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Pediatric Obsessive Compulsive Disorder (OCD) is a chronic, impairing condition that accrues significant concurrent and long-term risk to affected youth. Although empirically supported psychosocial and pharmacological treatments for OCD exist, many children and their families are not able to adequately access these treatments or derive only partial benefit from them. Such findings highlight the importance of developing more effective treatment options which have the potential to be widely accessible to OCD youth.
The investigators are proposing to test a computerized attention modification program, AMP, in six youth with OCD in an open case series to gather information regarding protocol acceptability, feasibility and preliminary efficacy. This phase includes the development and refinement of stimuli selection procedures, behavior avoidance task, EEG protocol, and AMP parameters for use with children.
Following ascertainment of study eligibility, participants will undergo a baseline assessment consisting of a clinical interview, neurocognitive assessments, EEG, attention bias assessment, and self report questionnaires. Study participants will then receive 12 sessions of AMP treatment over the course of three weeks. All youngsters and their families will be reassessed at treatment endpoint (week 4). Participation will take a total of about 24 hours over the course of six weeks. Participants who are treatment responders may be asked to return approximately 3 months after completing treatment for a follow-up assessment.
Preliminary hypotheses: 1) AMP will be acceptable to youth and families and feasible to administer; 2) Youth receiving AMP will demonstrate decreases in threat bias and OCD symptom severity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
OCD, obsessive compulsive disorder, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Attention Modification Program
Arm Type
Experimental
Arm Description
Attention Modification Program
Intervention Type
Behavioral
Intervention Name(s)
Attention Modification Program
Other Intervention Name(s)
AMP
Intervention Description
Computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief.
Primary Outcome Measure Information:
Title
Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment
Time Frame
pre-treatment (week 0) and post-treatment (week 5)
Secondary Outcome Measure Information:
Title
Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment
Time Frame
pre-treatment (week 0) and post-treatment (week 5)
Title
Attention Bias Assessment Change from Pre-Treatment to Post-Treatment
Description
Computerized assessment of attention bias
Time Frame
pre-treatment (week 0) and post-treatment (week 5)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Youth ages 8 - 17
Primary DSM-IV diagnosis of OCD as determined by Anxiety Disorders Interview Schedule (ADIS-IV) Child/Parent version
Child Yale-Brown Obsessive Compulsive Scale (CYBOCS) score > 15
Medication free or on stable medication for six weeks prior to study entry
Informed parental consent and child assent. Parents must agree to their child's participation in this protocol. Parents will be asked to fill out self-report questionnaires and participate in assessments that will provide us with more information about their child, however parents are not considered "participants" within this protocol, as all treatment is targeted toward their child.
Exclusion Criteria:
DSM-IV depressive disorder, bipolar disorder, PTSD, substance abuse/dependence, conduct disorder, PDD, schizophrenia, or mental retardation
Concurrent psychosocial treatment for OCD
IQ < 80
Youngsters with other comorbid disorders (e.g., anxiety, ADHD, ODD, tic disorder) will be eligible as long as these disorders are secondary to OCD in terms of severity and impairment and do not require immediate treatment initiation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanna Chang, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Piacentini, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
James McCraken, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series
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