Randomized Controlled Trial of Standard ERP and OC-Go (OC-GoPhaseII)
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|ClinicalTrials.gov Identifier: NCT03601312|
Recruitment Status : Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder||Behavioral: Exposure and Response Prevention Behavioral: OC-Go||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||32 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
All participants will receive 12 weeks of exposure/response/prevention (ERP). Sessions 1 (psychoeducation/hierarchy creation) and 12 (relapse prevention & generalization training) will be identical across both randomization groups.
Treatment sequences for the randomization groups will be as follows:
OC-GO-FIRST - Sessions 2-6: ERP+OC-Go, Sessions 7-11: Standard ERP
STANDARD ERP-FIRST - Sessions 2-6: Standard ERP, Sessions 7-11: ERP+OC-Go
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||The outcomes assessor will not have information about the participant's treatment condition, so they will not know whether or not they are receiving treatment as usual (Standard ERP) or OC-Go augmented ERP.|
|Official Title:||OC-Go: Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2020|
Active Comparator: Treatment-As-Usual
Individuals receiving treatment as usual will be receiving exposure and response prevention (ERP), the standard of care for pediatric OCD.
Behavioral: Exposure and Response Prevention
Exposure and response prevention is an evidence-based behavioral treatment that primarily focuses on exposures, in which the child faces OCD-related fears in a methodical manner and acquires more adaptive coping strategies.
Individuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application.
OC-Go is a HIPAA-compliant web-based clinician portal and patient-side mobile application that allows clinicians to create and push tailored treatment assignments to patients on their mobile devices. Individuals receiving this intervention will receive exposure and response prevention with OC-Go.
- Homework compliance [ Time Frame: End of Week 14 ]Homework Compliance (%; range 0-100) = (Total homework assignments completed treatment weeks 2-11/Total homework assignments assigned weeks 2-11) * 100
- Clinical Global Impression - Improvement Scale (acute) [ Time Frame: End of Week 6 ]The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response.
- Clinical Global Impression - Improvement Scale (crossover) [ Time Frame: End of Week 14 ]The CGI-I is a single-item clinician-rated measure of global improvement. Scores range from 1 (very much improved) to 7 (very much worse), with scores of 1 or 2 (much improved) indicating positive treatment response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601312
|Contact: John C Piacentini, Ph.D.||email@example.com|
|Contact: Silvia Orellana, B.A.||firstname.lastname@example.org|
|United States, California|
|Univ. of California / Los Angeles / Semel Inst.||Not yet recruiting|
|Los Angeles, California, United States, 90024-1759|
|Contact: John C Piacentini, PhD 310-825-0122 email@example.com|
|Contact: Caitlin Choy, B.A. 310-825-0122 firstname.lastname@example.org|
|Principal Investigator:||John Piacentini, Ph.D.||University of California, Los Angeles|