Improving Access to Child Anxiety Treatment

NCT03528109 | Unknown DMC

• 1 other identifier: IHS-2017C1-6400
• Study Type: interventional
• Target: 379
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Children's Yale-Brown Obsessive-Compulsive Scale

  The CY-BOCS is a measure of obsessive compulsive symptoms and severity. The Obsession Rating Scale measures 5 domains of obsessional severity on a scale from 0 (no impairment) to 4 (extreme impairment.) The Compulsion Rating Scale measures 5 domains of compulsion severity on a scale from 0 (no impairment) to 5 (extreme impairment.) The total range of OCD severity is reported on a scale from 0-40, with a higher score indicating greater severity.

  In-treatment and follow-up (6-12 months)

• Pediatric Anxiety Rating Scale

  The PARS is a measure of anxiety symptoms and severity. The Anxiety Severity Items are 7 questions meant to assess the frequency of anxiety symptoms and associated impairment. Items are measured on a scale from 0 (none) to 5 (extreme).The total range of anxiety severity is reported on a scale from 0-35, with a higher score indicating greater severity.

  In-treatment and follow-up (6-12 months)

Secondary Outcomes (24)

• Client Satisfaction Questionnaire-8

  In-treatment and follow-up (6-12 months)

• Clinical Global Impression Scales

  In-treatment and follow-up (6-12 months)

• Child Sheehan Disability Scale

  In-treatment and follow-up (6-12 months)

• Homework Compliance Form

  Up to 6 months

• Exposure Guide

  Up to 6 months

Study Arms (3)

patient-centered home CBT

EXPERIMENTAL

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)

Behavioral: Exposure Therapy

Provider-centered

ACTIVE COMPARATOR

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

Behavioral: Exposure Therapy

patient-centered telehealth CBT

EXPERIMENTAL

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.

Behavioral: Exposure Therapy

Interventions

Exposure Therapy BEHAVIORAL

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

Also known as: Exposure-Focused Cognitive Behavioral Therapy (CBT), ExRP

Provider-centered; patient-centered home CBT; patient-centered telehealth CBT

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bradley Hospital: lead
• Brown University: collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Bradley Hospital

Riverside, Rhode Island, 02915, United States

RECRUITING

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Anxiety Disorders; Phobic Disorders; Agoraphobia; Generalized Anxiety Disorder; Mutism; Anxiety, Separation; Phobia, Social; Panic Disorder

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Mental Disorders; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jennifer Freeman, PhD

  Warren Alpert Medical School of Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Freeman, PhD

CONTACT

4014321057; jfreeman@lifespan.org

Kate Sheehan, BS

CONTACT

401-432-1469; ksheehan5@lifespan.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2018
• First Posted: May 17, 2018
• Study Start: July 1, 2018
• Primary Completion: July 31, 2024
• Study Completion: February 1, 2025
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)