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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2012 by University of California, Los Angeles
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Susanna Chang, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01708226
First received: October 11, 2012
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Obsessive Compulsive Disorder
Behavioral: Attention Modification Program
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Attention Training for Childhood Obsessive Compulsive Disorder: An Open Case Series

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Attention Bias Assessment Change from Pre-Treatment to Post-Treatment [ Time Frame: pre-treatment (week 0) and post-treatment (week 5) ] [ Designated as safety issue: No ]
    Computerized assessment of attention bias


Estimated Enrollment: 6
Study Start Date: November 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Attention Modification Program
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 Name: AMP

  Eligibility

Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708226

Contacts
Contact: Olivia E Johnson, BA 310-825-2064 OJohnson@mednet.ucla.edu

Locations
United States, California
University of California Los Angeles Not yet recruiting
Los Angeles, California, United States, 90024
Contact: Susanna Chang, PhD    310-206-1040    schang@mednet.ucla.edu   
Contact: Olivia Johnson, BA    310-825-2064      
Principal Investigator: Susanna Chang, PhD         
Sponsors and Collaborators
University of California, Los Angeles
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
  More Information

Additional Information:
No publications provided

Responsible Party: Susanna Chang, PhD, Assistant Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01708226     History of Changes
Other Study ID Numbers: IRB12-001459, 1R34MH095885-01A1
Study First Received: October 11, 2012
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
OCD
obsessive compulsive disorder
children

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 22, 2014