Using Personalized Assessments in the Treatment of Childhood OCD

NCT06407648 | Recruiting

• 1 other identifier: IRB00406231
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obsessive-Compulsive Disorder

Keywords

children; adolescents; exposure with response prevention; cognitive behavioral therapy; ERP; CBT

Outcome Measures

Primary Outcomes (1)

• Children's Yale-Brown Obsessive-Compulsive Scale Second Edition (CY-BOCS-II) Total Severity Score

  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

Study Arms (2)

Personalized Assessments

EXPERIMENTAL

12 sessions of exposure with response prevention (ERP) that is guided by personalized assessments.

Other: Personalized Assessments

Standard of Care

ACTIVE COMPARATOR

12 sessions of exposure with response prevention (ERP) that is guided using standard practice.

Other: Standard of Care

Interventions

Personalized Assessments OTHER

Personalized CBT will use individualized OCD symptom networks to guide CBT strategies to target central symptom nodes in contemporaneous networks.

Personalized Assessments

Standard of Care OTHER

The standard CBT condition will use standard-of-care approaches to guide CBT strategies to target OCD symptoms.

Standard of Care

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Joseph F. McGuire, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Chang

CONTACT

443-300-8836; coach@jhmi.edu

Lauren Browning

CONTACT

443-300-8836; coach@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized parallel clinical trial

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: April 3, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)