Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series (AMPOCD)

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.

Study Overview

• Status: Completed
• Conditions: Obsessive Compulsive Disorder
• Intervention / Treatment: Behavioral: Attention Modification Program

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • University of California Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Attention Modification Program	Behavioral: Attention Modification Program; Computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief.; Other Names: AMP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment	pre-treatment (week 0) and post-treatment (week 5)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Global Impression-Severity (CGI-S) and Improvement (CGI-I) Scales Change From Pre-Treatment to Post-Treatment		pre-treatment (week 0) and post-treatment (week 5)
Attention Bias Assessment Change from Pre-Treatment to Post-Treatment	Computerized assessment of attention bias	pre-treatment (week 0) and post-treatment (week 5)

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Susanna Chang, PhD, University of California, Los Angeles; Principal Investigator: John Piacentini, PhD, University of California, Los Angeles; Principal Investigator: James McCraken, MD, University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 11, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): January 16, 2017
• Last Update Submitted That Met QC Criteria: January 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: OCD; children; obsessive compulsive disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Personality Disorders; Anxiety Disorders; Disease; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
• Other Study ID Numbers: IRB12-001459; 1R34MH095885-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No