Clinical trial NCT06934525: Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings
Official title: Testing Delivery of Modalities in Community Health Settings: Developing Pathways to Health Equity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Keywords: exposure therapy
cognitive behavioral therapy
anxiety treatment
exposure and response prevention therapy
ERP
pediatric anxiety treatment
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2025-04-18
Enrollment: 501
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

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

Primary outcomes:
measure: Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
timeFrame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
measure: Client Satisfaction Questionnaire-Revised (CSQ-8-R)
timeFrame: Week 8, Week 16 and follow-up (6 & 12 months)
measure: Exposure Guide
timeFrame: Weekly at Week 1 through 24.
measure: Pediatric Anxiety Rating Scale (PARS)
timeFrame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
measure: Clinical Global Impression Scales
timeFrame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
measure: Top Problems Assessment
timeFrame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
measure: Child Sheehan Disability Scale (CSDS)
timeFrame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
measure: Barriers to Treatment Questionnaire - Parent Version (BTQ-P)
timeFrame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Secondary outcomes:
measure: Homework Compliance Form
timeFrame: Weekly at Week 1 though 24
measure: Demographics
timeFrame: Baseline
measure: Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Neuropsychiatric Disorders (DIAMOND-Kid)
timeFrame: Baseline
measure: Caregiver Strain Questionnaire (CSQ)
timeFrame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
measure: Reasons for Treatment Discontinuation form
timeFrame: Administered only at discharge, up to 6-months into study
measure: Pediatric Accommodation Scale-Parent Report (PAS-PR)
timeFrame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
measure: Ask Suicide Screening Questions (ASQ)
timeFrame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
measure: The Cultural Formulation Interview (CFI)
timeFrame: Baseline
measure: Everyday Discrimination Scale (EDS)
timeFrame: Baseline
measure: Pediatric ACEs and Related Life Events Screener (PEARLS)
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References: