Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings
NCT06934525 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 501
Last updated 2026-05-14
Summary
The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., psychologist, social worker). This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom.
Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health.
The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.
Conditions
- Obsessive Compulsive Disorder (OCD)
- Pediatric Anxiety Disorders
- Anxiety Disorder
- Anxiety
- OCD
- Phobia
- Agoraphobia
- Generalized Anxiety
- Generalized Anxiety Disorder
- Selective Mutism
- Separation Anxiety
- Social Anxiety
- Social Anxiety Disorder
- Panic Disorder
- Pediatric Disorders
Interventions
- BEHAVIORAL
-
Team-delivered, exposure-based CBT
Patient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy
Sponsors & Collaborators
-
Patient-Centered Outcomes Research Institute
collaborator OTHER -
Bradley Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 5 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-01
- Primary Completion
- 2029-02-01
- Completion
- 2029-08-01
Countries
- United States
Study Locations
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