Improving Access to Child Anxiety Treatment

NCT03528109 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 379

Last updated 2022-08-03

No results posted yet for this study

Summary

There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth; patient-centered telehealth closed as of 5/1/21) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth (patient-centered telehealth closed as of 5/1/21), home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.

Conditions

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

Interventions

BEHAVIORAL

Exposure Therapy

A type of Cognitive Behavioral Therapy shown to be effective in the treatment of pediatric OCD and anxiety

Sponsors & Collaborators

  • Brown University

    collaborator OTHER
  • Patient-Centered Outcomes Research Institute

    collaborator OTHER
  • Bradley Hospital

    lead OTHER

Principal Investigators

  • Jennifer Freeman, PhD · Warren Alpert Medical School of Brown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2024-07-31
Completion
2025-02-01

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03528109 on ClinicalTrials.gov