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

Phase 1

Completed

• Conditions: Obsessive Compulsive Disorder
• Interventions: Behavioral: Attention Modification Program

• Registration Number: NCT01708226
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-15
• Study First Posted: 2012-10-16
• Study Start: 2012-11
• Primary Completion: 2013-11
• Study Completion: 2016-08
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-13
• Last Update Posted: 2017-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Attention Modification Program	Attention Modification Program	Attention Modification Program

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Attention Bias Assessment Change from Pre-Treatment to Post-Treatment	pre-treatment (week 0) and post-treatment (week 5)	Computerized assessment of attention bias
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)

Trial Locations

Locations (1)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States