Using Personalized Assessments in the Treatment of Childhood OCD

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Other: Personalized Assessments; Other: Standard of Care

• Registration Number: NCT06407648
• Lead Sponsor: Johns Hopkins University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-03
• Status Verified: 2024-05
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-09
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. be 8-17 years of age;
2. meet diagnostic criteria for a primary diagnosis of OCD on a structured clinical interview;
3. have moderate OCD severity as evidenced by a CY-BOCS total score of ≥16;
4. medication free and/or on a stable dose of medication 8 weeks prior to study participation;
5. be English speaking.

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Exclusion Criteria

1. the presence of psychotic disorder, bipolar disorder, or autism spectrum disorders;
2. significant suicidal ideation that warrants medical intervention;
3. concurrent psychotherapy for OCD;
4. inability to complete scales, or attend visits.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized Assessments	Personalized Assessments	12 sessions of exposure with response prevention (ERP) that is guided by personalized assessments.
Standard of Care	Standard of Care	12 sessions of exposure with response prevention (ERP) that is guided using standard practice.

Primary Outcome Measures

Name	Time	Method
Children's Yale-Brown Obsessive-Compulsive Scale Second Edition (CY-BOCS-II) Total Severity Score	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.

Trial Locations

Locations (1)

Johns Hopkins University School of Medicine; 🇺🇸 Baltimore, Maryland, United States