Randomized Controlled Trial of Standard ERP and OC-Go

Study Overview
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Brief Summary
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Phase II of this study will examine the efficacy of the OC-Go application via a randomized controlled trial comparing standard exposure and response prevention (ERP) treatment for pediatric obsessive compulsive disorder (OCD) to exposure/response prevention (ERP) augmented with OC-Go. A cross-over design will be implemented for these 12 sessions of treatment, in which participants that were randomized to standard ERP will receive OC-Go augmented ERP for the second half of treatment, and vice versa. Efficacy will be investigated in a sample of 32 children with OCD.

Detailed Description
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This project seeks to refine and assess OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application designed to increase patient adherence to evidence-based treatment (EBT) for OCD, a common and impairing condition, and provider ability to effectively implement EBTs. OC-Go allows clinicians to create and push tailored assignments to patients on their mobile devices with an optimized user interface that includes patient accountability and support features. Accordingly, patients can be guided to do assignments by themselves between sessions with increased fidelity over the course of treatment. Once therapy assignments are created and shared to a crowd-sourced and curated public library, any clinician can assign any task to any patient for homework or in-session use with one touch. Use of OC-Go is expected to increase patient engagement, compliance, treatment efficiency, dissemination of EBTs, and therapist confidence and expertise.

Official Title
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OC-Go: Facilitating Fidelity and Dissemination of Evidence Based Treatment for Childhood OCD Via an Interactive Crowd-sourced Patient-provider Tool

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: Exposure and Response Prevention
* Behavioral: OC-Go


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 9-17 years old Primary diagnosis of OCD based on diagnostic interview (ADIS) CGI-Severity score > 3 Exclusion Criteria: Anti-OCD medication/unstable dose (with changes expected during the study) Significant and interfering comorbid psychiatric, psychosocial, neurological, or medical condition (e.g., acute suicidality, low IQ, etc.) precluding the child's ability to complete all study procedures

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment-As-Usual<br>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<br>* 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.<br>|
| Experimental: OC-Go<br>Individuals in the OC-Go group will be receiving exposure and response prevention (ERP) augmented by the OC-Go application. | Behavioral: OC-Go<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homework compliance | Homework Compliance (%; range 0-100) = (Total homework assignments completed treatment weeks 2-11/Total homework assignments assigned weeks 2-11) * 100 | End of Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression - Improvement Scale (acute) | 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. | End of Week 6 | 
| Clinical Global Impression - Improvement Scale (crossover) | 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. | End of Week 14 |