Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings (IMPACT-RI)

Bradley Hospital

Status: Begins enrollment in 4 months

Conditions: Social Anxiety; Selective Mutism; Anxiety Disorder; Obsessive Compulsive Disorder (OCD); Anxiety; Separation Anxiety; OCD; Panic Disorder; Pediatric Anxiety Disorders; Pediatric Disorders; Generalized Anxiety Disorder; Social Anxiety Disorder; Agoraphobia; Generalized Anxiety; Phobia

Treatments: Behavioral: Team-delivered, exposure-based CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT06934525

BPS2023C233953

Details and patient eligibility

About

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.

Full description

The goal of this study is to increase equitable access to high quality care for all youth with anxiety and their families by comparing treatment modalities to determine which is best for whom in a comprehensive, state-wide approach (Rhode Island; RI) involving collaboration with a robust partner network offering a wide range of relevant experiences and expertise. To deliver care, the study team is partnering with Certified Community Behavioral Health Centers and a Federally Qualified Health Center representing a large proportion of historically marginalized youth across RI. Study results will inform the optimal delivery modality for enabling organizations to provide high-quality care that is more accessible, coordinated, and efficient, and that would ultimately improve patient centered outcomes. Using a Hybrid Type 1 effectiveness-implementation design will also allow us to assess contextual factors affecting widespread implementation and sustainment of each delivery modality.

Enrollment: 501 estimated patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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501 participants in 3 patient groups

Flexible

Other group

Description:

Families and providers will collaboratively choose treatment delivery modality (in-person versus telehealth) on a session-by-session basis.

Treatment:

Behavioral: Team-delivered, exposure-based CBT

In-person

Other group

Description:

Families will only attend sessions in-person. Sessions may occur at the family's home, in the community, or in the provider's office.

Treatment:

Behavioral: Team-delivered, exposure-based CBT

Telehealth

Other group

Description:

Families will only attend sessions via a secure remote video platform.

Treatment:

Behavioral: Team-delivered, exposure-based CBT