RECRUITING

Improving Access to Child Anxiety Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparison of Patient-Centered Versus Provider-Centered Delivery of Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety and Obsessive Compulsive Disorder (OCD)

Quick Facts

Study Start:2018-07-01
Study Completion:2025-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03528109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * age 5-18 inclusive
  2. * primary or co-primary DSM-V diagnosis of anxiety or OCD
  3. * symptom duration of at least 3 months
  4. * outpatient care needed
  5. * presence of a stable parent, or guardian, who can participate in treatment
  1. * other primary or co-primary psychiatric disorder which requires initiation of other active current treatment
  2. * documented mental retardation
  3. * thought disorder or psychotic symptoms
  4. * conduct disorder
  5. * acute suicidality
  6. * concurrent psychotherapy
  7. * chronic medical illness that would preclude their active participation in treatment
  8. * treatment with psychotropic medication that is not stable

Contacts and Locations

Study Contact

Jennifer Freeman, PhD
CONTACT
4014321057
jfreeman@lifespan.org
Kate Sheehan, BS
CONTACT
401-432-1469
ksheehan5@lifespan.org

Principal Investigator

Jennifer Freeman, PhD
PRINCIPAL_INVESTIGATOR
Warren Alpert Medical School of Brown University

Study Locations (Sites)

Bradley Hospital
Riverside, Rhode Island, 02915
United States

Collaborators and Investigators

Sponsor: Bradley Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-01
Study Completion Date2025-02-01

Study Record Updates

Study Start Date2018-07-01
Study Completion Date2025-02-01

Terms related to this study

Additional Relevant MeSH Terms

  • 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