Improving Access to Child Anxiety Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

379 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2025-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Implementing Team-Based Treatment for Pediatric Anxiety in Community Mental Health Settings

NCT06934525

Obsessive Compulsive Disorder (OCD) Pediatric Anxiety Disorders Anxiety Disorder +12 more

RECRUITING NA

Quality Assessment in Exposure Therapy

NCT03182101

Obsessive-Compulsive Disorder in Children

UNKNOWN NA

Family Based Treatment of Early Childhood Obsessive Compulsive Disorder

NCT00055068

Obsessive-Compulsive Disorder

COMPLETED PHASE3

Behavior Therapy for Children and Adolescents With Obsessive-Compulsive Disorder (OCD)

NCT00000386

Obsessive-Compulsive Disorder

COMPLETED PHASE3

CBT for Pediatric OCD: Community Training Pilot

NCT02202915

Obsessive Compulsive Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

patient-centered home CBT

60 minute office-based exposure therapy with a PhD psychologist once per month and a 90 minute community-based CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week)

Group Type EXPERIMENTAL

Exposure Therapy

Intervention Type BEHAVIORAL

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

Provider-centered

60 minute office-based exposure therapy with a PhD psychologist four times per month (once per week)

Group Type ACTIVE_COMPARATOR

Exposure Therapy

Intervention Type BEHAVIORAL

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

patient-centered telehealth CBT

60 minute telehealth exposure therapy with a PhD psychologist once per month and a 90 minute telehealth CBT with a mobile exposure coach three times per month for a total of four visits per month (once per week). Patient-centered telehealth was closed when the recruitment goal was met in May 2021.

Group Type EXPERIMENTAL

Exposure Therapy

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exposure Therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exposure-Focused Cognitive Behavioral Therapy (CBT), ExRP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No