- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407648
Using Personalized Assessments in the Treatment of Childhood OCD
May 7, 2026 updated by: Johns Hopkins University
The primary purpose of this study is to learn whether personalized assessment of obsessive-compulsive disorder (OCD) symptoms in childhood OCD using mobile health technology are feasible and acceptable for youth and parents.
The investigators will also examine whether personalized cognitive-behavioral therapy (CBT) that is informed by personalized OCD assessments yields better clinical outcomes when compared to standard CBT for youth with OCD
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexandra Chang
- Phone Number: 443-300-8836
- Email: coach@jhmi.edu
Study Contact Backup
- Name: Lauren Browning
- Phone Number: 443-300-8836
- Email: coach@jhmi.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins University School of Medicine
-
Contact:
- Joseph McGuire, PhD
- Phone Number: 443-287-7157
- Email: coach@jhmi.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- be 8-17 years of age;
- meet diagnostic criteria for a primary diagnosis of OCD on a structured clinical interview;
- have moderate OCD severity as evidenced by a CY-BOCS total score of ≥16;
- medication free and/or on a stable dose of medication 8 weeks prior to study participation;
- be English speaking.
Exclusion Criteria:
- the presence of psychotic disorder, bipolar disorder, or autism spectrum disorders;
- significant suicidal ideation that warrants medical intervention;
- concurrent psychotherapy for OCD;
- inability to complete scales, or attend visits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Personalized Assessments
12 sessions of exposure with response prevention (ERP) that is guided by personalized assessments.
|
Personalized CBT will use individualized OCD symptom networks to guide CBT strategies to target central symptom nodes in contemporaneous networks.
|
|
Active Comparator: Standard of Care
12 sessions of exposure with response prevention (ERP) that is guided using standard practice.
|
The standard CBT condition will use standard-of-care approaches to guide CBT strategies to target OCD symptoms.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Children's Yale-Brown Obsessive-Compulsive Scale Second Edition (CY-BOCS-II) Total Severity Score
Time Frame: Screen, Baseline (Week 0), Week 4, Week 8, and Week 12
|
A clinician-rated measure of OCD symptom severity in the past week.
This 10-item measure is rated on a 0 to 5 scale with a total score ranging from 0 to 50.
A higher total score is reflective of greater OCD symptom severity.
|
Screen, Baseline (Week 0), Week 4, Week 8, and Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph F. McGuire, PhD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 3, 2024
Primary Completion (Estimated)
July 30, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
May 6, 2024
First Submitted That Met QC Criteria
May 6, 2024
First Posted (Actual)
May 9, 2024
Study Record Updates
Last Update Posted (Actual)
May 11, 2026
Last Update Submitted That Met QC Criteria
May 7, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00406231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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