Clinical trial NCT03528109: Improving Access to Child Anxiety Treatment
Official title: Comparison of Patient-Centered Versus Provider-Centered Delivery of Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety and Obsessive Compulsive Disorder (OCD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Bradley Hospital
Sponsor class: OTHER
Collaborators: name: Brown University
name: Patient-Centered Outcomes Research Institute
First posted: 2018-05-17
Enrollment: 379
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* age 5-18 inclusive
* primary or co-primary DSM-V diagnosis of anxiety or OCD
* symptom duration of at least 3 months
* outpatient care needed
* presence of a stable parent, or guardian, who can participate in treatment

Exclusion Criteria:

* other primary or co-primary psychiatric disorder which requires initiation of other active current treatment
* documented mental retardation
* thought disorder or psychotic symptoms
* conduct disorder
* acute suicidality
* concurrent psychotherapy
* chronic medical illness that would preclude their active participation in treatment
* treatment with psychotropic medication that is not stable

Primary outcomes:
measure: Children's Yale-Brown Obsessive-Compulsive Scale
timeFrame: In-treatment and follow-up (6-12 months)
measure: Pediatric Anxiety Rating Scale
timeFrame: In-treatment and follow-up (6-12 months)
Secondary outcomes:
measure: Client Satisfaction Questionnaire-8
timeFrame: In-treatment and follow-up (6-12 months)
measure: Clinical Global Impression Scales
timeFrame: In-treatment and follow-up (6-12 months)
measure: Child Sheehan Disability Scale
timeFrame: In-treatment and follow-up (6-12 months)
measure: Homework Compliance Form
timeFrame: Up to 6 months
measure: Exposure Guide
timeFrame: Up to 6 months
measure: Therapeutic Alliance Scales for Caregivers and Parents (TASCP)
timeFrame: Up to 6 months
measure: Therapeutic Alliance Scales for Children-Revised (TASC-r)
timeFrame: Up to 6 months
measure: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)
timeFrame: In-treatment and follow-up (6-12 months)
measure: Top Problems Assessment (TPA)
timeFrame: In-treatment and follow-up (6-12 months)
measure: Caregiver Strain Questionnaire (CSQ)
timeFrame: In-treatment and follow-up (6-12 months)
measure: Barriers to Treatment Questionnaire - Parent Version (BTQ-P)
timeFrame: In-treatment and follow-up (6-12 months)
measure: Pediatric Accommodation Scale-Parent Report (PAS-PR)
timeFrame: In-treatment and follow-up (6-12 months)
measure: Randomization Debrief
timeFrame: Administered at baseline
measure: Treatment Expectancy
timeFrame: Administered at baseline
measure: The Social Responsiveness Scale, Second Edition (SRS-2)
timeFrame: Administered at baseline and at discharge (up to 6-months)
measure: Affective Reactivity Index - Parent Version (ARI-P)
timeFrame: In-treatment and follow-up (6-12 months)
measure: Affective Reactivity Index - Self Report (ARI-S)
timeFrame: In-treatment and follow-up (6-12 months)
measure: Distress Intolerance Index
timeFrame: In-treatment and follow-up (6-12 months)
measure: Parent Accommodation Scale (PAS)
timeFrame: In-treatment and follow-up (6-12 months)
measure: Feedback Forms - Caregiver and Child Versions
timeFrame: Administered only at discharge, up to 6-months into study
measure: End of Treatment Form
timeFrame: Administered only at discharge, up to 6-months into study
measure: Sharing Study Findings
timeFrame: Administered only at discharge, up to 6-months into study
measure: Treatment Attendance
timeFrame: Up to 6 months
measure: Reasons for Treatment Discontinuation form
timeFrame: Administered only at discharge, up to 6-months into study
Other outcomes:
Locations:
city: Riverside
country: United States
facility: Bradley Hospital
state: Rhode Island
Study officials:
affiliation: Warren Alpert Medical School of Brown University
name: Jennifer Freeman, PhD
role: PRINCIPAL_INVESTIGATOR
References: