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Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings.

Study acronym: IMPACT-RI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 8 → 2 primary endpoints
See other at-risk trials from Bradley Hospital

Record History

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  1. Notable Primary endpoint(s) modified
    • Secondary endpoints: 12 to 10
    • Study description expanded, about 418 words
    • Study title expanded, about 2 words
    v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Primary endpoints revised (8)
    • Study sites: 0 to 1
    • Secondary endpoints: 10 to 12
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
3,263 trials monitored
See 159 trials at risk
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., social worker) who also provides weekly supervision for the exposure coach. 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.
Trial Details
NCT Number NCT06934525
Lead Sponsor Bradley Hospital
Collaborators: Patient-Centered Outcomes Research Institute
Conditions
(from sponsor)
Obsessive Compulsive Disorder (OCD), Pediatric Anxiety Disorders, Anxiety Disorder, Anxiety, OCD, Phobia, Agoraphobia, Generalized Anxiety +7 more
Related terms Agoraphobia, Anxiety Disorders, Anxiety, Separation, Generalized Anxiety Disorder, Mutism, Obsessive-Compulsive Disorder, Panic Disorder, Phobia, Social, Phobic Disorders
Enrollment 501 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov