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

NCT01708226 | Completed Phase 1 DMC

• 2 other identifiers: IRB12-0014591R34MH095885-01A1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive Compulsive Disorder

Keywords

OCD; obsessive compulsive disorder; children

Outcome Measures

Primary Outcomes (1)

• Children's Yale-Brown Obsessive Compulsive Scale Change From Pre-Treatment to Post-Treatment

  pre-treatment (week 0) and post-treatment (week 5)

Secondary Outcomes (2)

• 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

  pre-treatment (week 0) and post-treatment (week 5)

Study Arms (1)

Attention Modification Program

EXPERIMENTAL

Attention Modification Program

Behavioral: Attention Modification Program

Interventions

Attention Modification Program BEHAVIORAL

Computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief.

Also known as: AMP

Attention Modification Program

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Adenosine Monophosphate

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 16, 2012
• Study Start: November 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: August 1, 2016
• Last Updated: January 16, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)