Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
333

Summary

Conditions
  • Anxiety Disorders
  • Agoraphobia
  • Anxiety
  • Generalized Anxiety
  • Separation Anxiety
  • Social Anxiety
  • Generalized Anxiety Disorder
  • Obsessive Compulsive Disorder
  • OCD
  • Panic Disorder
  • Pediatric Disorder
  • Phobia
  • Social Anxiety Disorder
  • Selective Mutism
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 5 years and 18 years
Gender
Both males and females

Description

Anxiety disorders are a significant public health problem that cause suffering for youth and their families, derail normal childhood development, and when left untreated persist into adulthood with high societal costs. Cognitive Behavioral Treatment (CBT) including exposure therapy is the treatment ...

Anxiety disorders are a significant public health problem that cause suffering for youth and their families, derail normal childhood development, and when left untreated persist into adulthood with high societal costs. Cognitive Behavioral Treatment (CBT) including exposure therapy is the treatment of choice, yet multiple barriers limit access to care. Even for families with access to care, traditional provider-centered (office based) treatment presents challenges and can limit effectiveness for many youth and families. Home- and Community-based exposure therapy is efficacious for patients who previously did not improve with provider-centered services, and input from family stakeholders suggests that treatment in these settings is an optimal match for their needs. Patient-centered models involving home visits and provider teams have consistently demonstrated increased treatment accessibility and engagement. However, there has been no comprehensive comparison of exposure delivered by patient-centered teams using home visits versus by provider-centered office visits alone for childhood anxiety. The absence of comparative effectiveness research (CER) data impedes targeted use of patient centered versus traditional outpatient treatment and would better allocate limited resources, provide the best quality care, and help patients and families make educated decisions about their treatment choices. Telehealth has strong evidence for effectiveness for youth with anxiety and OCD when delivered by a licensed provider, with treatment responder rates ranging from 73-82% (Carpenter, et al., 2018; Comer et al., 2017; Storch et al., 2011). Although traditional telehealth treatments can address barriers associated with in-person treatment, it has yet to be leveraged to increase service capacity. The overall goal of this proposal is to compare two models of service delivery, patient-centered delivery (utilizing novel deployment of personnel both in-home and via telehealth, patient-centered telehealth closed as of 5/1/21) vs. traditional provider-centered delivery, of CBT in youth ages 5-18 receiving exposure therapy for anxiety. A total of 379 children will be treated, with 166 (or 167) children randomly assigned to provider-centered, 166 (or 167) assigned to patient-centered in-home, and 46 assigned to patient-centered telehealth treatment conditions. The patient-centered telehealth condition was added in 2020 in response the COVID-19 global pandemic and closed when the recruitment goal was reached in May 2021. Telehealth treatment models are a necessary health system adaptation in the current health crisis, but also may improve access to care post pandemic. We hope including telehealth as a comparator in our service delivery compared effectiveness trial will be highly informative and relevant for the future mental healthcare landscape. A trained independent evaluator (IE) blind to condition will measure patient and family treatment engagement, anxiety symptoms/severity, and functional impairment at baseline, during active treatment at weeks 6, 12, 18, and 24, and 3- and 6-month follow-up after acute treatment. The primary aims are to compare the relative effectiveness of patient-centered vs. provider-centered treatment for: 1) improving family treatment engagement/satisfaction, 2) reducing anxiety symptoms, and 3) reducing associated disability (quality of life and functional impairment). Secondary outcomes are to understand moderators of treatment response including: severity of illness, caregiver burden/family accommodation, and barriers to treatment access and to explore group differences in time course of response, durability of treatment gains, provider volume/capacity and efficiency in patient centered versus provider centered treatment.

Tracking Information

NCT #
NCT03528109
Collaborators
  • Brown University
  • Patient-Centered Outcomes Research Institute
Investigators
Principal Investigator: Jennifer Freeman, PhD Warren Alpert Medical School of Brown University