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

Obsessive Compulsive Disorder Clinical Trial

— AMPOCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708226
• Other study ID #: IRB12-001459
• Secondary ID: 1R34MH095885-01A
• Status: Completed
• Phase: Phase 1
• First received: October 11, 2012
• Last updated: January 13, 2017
• Start date: November 2012
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: August 2016
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Compulsive Behavior
• Disease
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment		pre-treatment (week 0) and post-treatment (week 5)
Secondary	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)
Secondary	Attention Bias Assessment Change from Pre-Treatment to Post-Treatment	Computerized assessment of attention bias	pre-treatment (week 0) and post-treatment (week 5)

External Links

•   Link to the UCLA Child OCD, Anxiety, and Tic Disorders Program webpage that includes descriptions of research studies and contact information.