NCT06934525 Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings
| NCT ID | NCT06934525 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bradley Hospital |
| Condition | Obsessive Compulsive Disorder (OCD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 501 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2029-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 501 participants in total. It began in 2025-11-01 with a primary completion date of 2029-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Age 5-18 inclusive * Primary or co-primary DSM-V diagnosis of anxiety or OCD * Symptom duration of at least 3 months * Outpatient care needed * Presence of a stable parent, or guardian, who can participate in treatment Exclusion Criteria: * Other primary or co-primary psychiatric disorder which requires initiation of other active current treatment * Acute suicidality * Concurrent psychotherapy * Chronic medical illness that would preclude their active participation in treatment * Treatment with psychotropic medication that is not stable
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06934525 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 18 Years, studying Obsessive Compulsive Disorder (OCD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06934525 currently recruiting?
Yes, NCT06934525 is actively recruiting participants. Contact the research team at jfreeman@brownhealth.org for enrollment information.
Where is the NCT06934525 trial being conducted?
This trial is being conducted at East Providence, United States.
Who is sponsoring the NCT06934525 clinical trial?
NCT06934525 is sponsored by Bradley Hospital. The trial plans to enroll 501 participants.