501 Participants Needed

Cognitive Behavioral Therapy for Pediatric Anxiety

(IMPACT-RI Trial)

JF
Overseen ByJennifer Freeman, PhD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Bradley Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for children aged 5-18 with a primary or co-primary diagnosis of anxiety or OCD, who have had symptoms for at least 3 months and need outpatient care. They must have a stable parent or guardian to participate in treatment.

Inclusion Criteria

I need care that does not require hospital admission.
I have a stable guardian to support me during treatment.
I am between the ages of 5 and 18.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • Team-delivered, exposure-based CBT
Trial Overview The study tests Cognitive Behavioral Therapy (CBT) delivery methods for pediatric anxiety and OCD: in-person, telehealth, and flexible (a mix). It involves weekly sessions with an exposure coach and monthly visits with a licensed provider.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: TelehealthExperimental Treatment1 Intervention
Group II: In-personExperimental Treatment1 Intervention
Group III: FlexibleExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bradley Hospital

Lead Sponsor

Trials
22
Recruited
1,900+

Patient-Centered Outcomes Research Institute

Collaborator

Trials
592
Recruited
27,110,000+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security