Testing Delivery of Modalities in Community Health Settings: Developing Pathways to Health Equity

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Rhode Island
Bradley Hospital
RECRUITING
East Providence
Contact Information
Primary
Jennifer Freeman, PhD
jfreeman@brownhealth.org
401-432-1000
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2029-08-01
Participants
Target number of participants: 501
Treatments
Other: Flexible
Families and providers will collaboratively choose treatment delivery modality (in-person versus telehealth) on a session-by-session basis.
Other: In-person
Families will only attend sessions in-person. Sessions may occur at the family's home, in the community, or in the provider's office.
Other: Telehealth
Families will only attend sessions via a secure remote video platform.
Sponsors
Leads: Bradley Hospital
Collaborators: Patient-Centered Outcomes Research Institute

This content was sourced from clinicaltrials.gov