Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings

Part of paid clinical trials in East Providence, Rhode Island.

Sponsor
Bradley Hospital
Study ID
NCT06934525
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
5 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Team-delivered, exposure-based CBT — BEHAVIORAL
    Patient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
May 2026
Primary completion
Feb 1, 2029
Completion
Aug 1, 2029

Study Design

Enrollment
501 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Children's Yale-Brown Obsessive-Compulsive Scale Second Edition: (CY-BOCS II) [ Time Frame: Baseline, Week 8, Week 16 and follow-up (6 & 12 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Bradley HospitalEast ProvidenceRhode Island02915
Jennifer Freeman, PhD
[email protected]
4014321057

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