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

NCT06934525 | Recruiting DMC

• 1 other identifier: BPS2023C233953
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test how the delivery of Cognitive Behavioral Therapy (CBT) for pediatric anxiety and OCD via different methods might increase its availability and effectiveness. CBT involves teaching the patient skills to enable them to gradually come into contact with feared situations. This process of gradually approaching feared situations is called exposure. Although CBT with exposure has the best evidence for treating anxiety disorders, not all children have equal access or respond the same way to CBT. As part of this study, patients will receive weekly CBT treatment sessions involving a combination of weekly visits with an exposure coach and one visit a month with a licensed provider (e.g., psychologist, social worker). This treatment will be delivered using one of three methods: 1) in-person (face-to-face sessions, occurring in the office and the home/community), or 2) telehealth (entirely remote sessions via web-based video conference), or 3) flexible (individualized mix of in-person and/or telehealth sessions). Eligible participants will be randomly assigned to one of these three methods. Results of this study will help determine which treatment method works best for whom. Treatment as described above will occur as part of care at partnering community care sites in Rhode Island. Providers from the following partnering community care sites will make up patient treatment teams: Blackstone Valley Community Health Care, Family Services of Rhode Island, Gateway Healthcare, Newport Mental Health, and Thrive Behavioral Health. The research study is being conducted by the Pediatric Anxiety Research Center at Brown University Health. The research team will conduct the study assessments that patients will be asked to participate in as study participants. Patients will be asked to complete assessments prior to starting treatment, at two time points during treatment, at the end of treatment, and at two timepoints 3 and 6 months following the end of treatment. Participants will be compensated for their time completing research assessments.

Conditions

Obsessive Compulsive Disorder (OCD); Pediatric Anxiety Disorders; Generalized Anxiety Disorder; Anxiety Disorder; Anxiety; OCD; Phobia; Agoraphobia; Generalized Anxiety; Selective Mutism; Separation Anxiety; Social Anxiety; Social Anxiety Disorder; Panic Disorder; Pediatric Disorders

Keywords

exposure therapy; cognitive behavioral therapy; anxiety treatment; exposure and response prevention therapy; ERP; pediatric anxiety treatment

Outcome Measures

Primary Outcomes (8)

• Children's Yale-Brown Obsessive-Compulsive Scale Second Edition: (CY-BOCS II)

  The CY-BOCS II is a measure of obsessive-compulsive symptoms and their severity. The Obsession Rating Scale assesses five domains of obsessional severity, each scored from 0 (no impairment) to 5 (extreme impairment). The Compulsion Rating Scale assesses five domains of compulsion severity using the same 0-5 scale. The total OCD severity score ranges from 0 to 50, with higher scores indicating greater symptom severity.

  Baseline, Week 8, Week 16 and follow-up (6 & 12 months)

• Client Satisfaction Questionnaire-Revised (CSQ-8-R)

  The CSQ-8-R measures consumer satisfaction with mental health services; satisfaction is measured using 8 items on a scale from 1 (Poor) to 4 (Excellent). Total satisfaction ranges from 8-32, with a high score indicating greater satisfaction.

  Week 8, Week 16 and follow-up (6 & 12 months)

• Exposure Guide

  The Exposure Guide is an empirically-supported exposure therapy fidelity/quality tool completed by study therapists. It measures exposure quality, including: therapist use of specific strategies that predict clinical improvement, exposure completion, exposure difficulty, therapeutic learning, barriers to completion, and engagement.

  Weekly at Week 1 through 24.

• Pediatric Anxiety Rating Scale (PARS)

  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.

  Baseline, Week 8, Week 16 and follow-up (6 & 12 months)

• Clinical Global Impression Scales

  The CGI is a clinician-rated measures of global severity and improvement. The Severity of illness scale reports the severity of current symptoms on a scale from 1 (not at all ill) to 7 (among the most extremely ill patients.) The Global Improvement Scale tracks improvement since treatment initiation on a scale from 1 (very much improved) to 7 (very much worse). The highest possible score on either scale is 7, indicating extreme severity or worse treatment outcome.

  Baseline, Week 8, Week 16 and follow-up (6 & 12 months)

• Top Problems Assessment

  The TPA is designed to independently solicit from youth and parents the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).

  Baseline, Week 8, Week 16 and follow-up (6 & 12 months)

• Child Sheehan Disability Scale (CSDS)

  The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.

  Baseline, Week 8, Week 16 and follow-up (6 & 12 months)

• Barriers to Treatment Questionnaire - Parent Version (BTQ-P)

  The BTQ-P is a 28-item measure adapted from the BTQ to assess parent perceptions of barriers to accessing treatment for their child's anxiety. The measure is completed at the outset of treatment and assesses such domains as logistic and financial barriers, stigma, and aspects of treatment. Items are rated on a 0 ("not at all true") to 2 ("mostly true") scale.

  Baseline, Week 8, Week 16 and follow-up (6 & 12 months)

Secondary Outcomes (12)

• Homework Compliance Form

  Weekly at Week 1 though 24

• Demographics

  Baseline

• Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and related Neuropsychiatric Disorders (DIAMOND-Kid)

  Baseline

• Caregiver Strain Questionnaire (CSQ)

  Baseline, Week 8, Week 16 and follow-up (6 & 12 months)

• Reasons for Treatment Discontinuation form

  Administered only at discharge, up to 6-months into study

Study Arms (3)

Flexible

OTHER

Families and providers will collaboratively choose treatment delivery modality (in-person versus telehealth) on a session-by-session basis.

Behavioral: Team-delivered, exposure-based CBT

In-person

OTHER

Families will only attend sessions in-person. Sessions may occur at the family's home, in the community, or in the provider's office.

Behavioral: Team-delivered, exposure-based CBT

Telehealth

OTHER

Families will only attend sessions via a secure remote video platform.

Behavioral: Team-delivered, exposure-based CBT

Interventions

Team-delivered, exposure-based CBT BEHAVIORAL

Patient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy

Flexible; In-person; Telehealth

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
• 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
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Bradley Hospital

East Providence, 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

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

Central Study Contacts

Jennifer Freeman, PhD

CONTACT

401-432-1000; jfreeman@brownhealth.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: April 3, 2025
• First Posted: April 18, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 8, 2025

Record last verified: 2025-04

Locations

US (1)