Testing Delivery Modalities of Team-Based CBT for Pediatric Anxiety in Community Health Settings. (IMPACT-RI)

Testing Delivery Modalities of Team-Based Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety in Community Health Settings: Developing Pathways to Health Equity

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., social worker) who also provides weekly supervision for the exposure coach. 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.

Study Overview

• Status: Recruiting
• Conditions: OCD; Generalized Anxiety Disorder; Anxiety; Social Anxiety; Social Anxiety Disorder; Panic Disorder; Phobia; Agoraphobia; Anxiety Disorder; Selective Mutism; Generalized Anxiety; Separation Anxiety; Obsessive Compulsive Disorder (OCD); Pediatric Disorders; Pediatric Anxiety Disorders
• Intervention / Treatment: Behavioral: Team-delivered, exposure-based CBT

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. Youth from historically marginalized groups face even greater barriers to accessing high-quality care, including limited availability and inconvenience of services, transportation difficulties, lower mental health literacy, and experiences of stigmatization and discrimination. Systematic reviews consistently show comparable outcomes for in-person vs. telehealth treatment for anxiety yet results highlight the lack of rigorous comparative research in understanding which patient subgroups are more likely to benefit from different delivery modalities, making the process of selecting among them more confusing than ever for families. In the wake of the COVID-19 pandemic, using a flexible service modality (i.e., custom mix of telehealth and in-person sessions) has also become common practice. The question of how best to improve access to high quality care is particularly relevant in community health settings (e.g., Certified Community Behavioral Health Centers (CCBHCs) and Federally Qualified Health Centers (FQHCs)) that serve a high proportion of vulnerable youth due to the staggering and longstanding failure to include these youth in clinical trials and the clear need to tailor treatment to better address barriers to access, quality, and clinical improvement. The overall goal of this proposal is to compare three modalities for delivering outpatient exposure-based CBT in youth ages 5-18 using existing care teams in CCBHC/FQHC ("safety net") settings: in-person (traditional face-to-face sessions only, occurring in the office and home/community) vs. telehealth (only occurring remotely via web-based video conference) vs. flexible (tailored mix of telehealth and/or in-person sessions). A total of 501 children with anxiety and/or OCD will be treated, with 167 children randomly assigned to each of the treatment conditions. A trained independent evaluator (IE) masked to condition will measure patient and family treatment engagement, anxiety symptoms/severity, and functional impairment at baseline, during active treatment at weeks 8, 16, and 24, and 3- and 6-month follow-up after acute treatment. The primary aims are to compare the relative effectiveness of in-person vs. telehealth vs. flexible CBT for: reducing anxiety-related functional impairment, improving family treatment engagement, improving family satisfaction, reducing barriers to treatment access, and maintaining treatment quality. Secondary outcomes are to understand predictors of pre- to post-treatment change in functional impairment including severity of illness, caregiver burden, and family accommodation and to explore group differences in time course of response and durability of treatment gains. Longer-term goals include establishing a service delivery model that can be scaled nationally in similar practice settings. Primary outcomes are driven by real world needs of patients and families and selected in collaboration with stakeholders. The approach for all aims will involve regression of the outcome variable on treatment group (flexible vs in-person or telehealth), randomization stratification factors (minoritized race/ethnicity, site), a small number of pre-specified covariates that are hypothesized to be strongly associated with the outcome (age, poverty), and baseline value of the outcome, as appropriate. This is the ANCOVA approach to analysis in randomized controlled trials. Missing data will be handled with multiple imputation using chained equations. In secondary analyses, we will evaluate the potential impact of missing data and assumptions regarding the relationship of missing data mechanisms and treatment effect estimates using sensitivity analyses.

• Study Type: Interventional
• Enrollment (Estimated): 501
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Freeman, PhD; Phone Number: 401-432-1000; Email: jfreeman@brownhealth.org

Study Locations

• United States
  • Rhode Island
    • East Providence, Rhode Island, United States, 02915
      • Recruiting
      • Bradley Hospital
      • Contact: Jennifer Freeman, PhD; Phone Number: 4014321057; Email: jfreeman@brownhealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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
• Acute suicidality
• Concurrent psychotherapy
• Chronic medical illness that would preclude their active participation in treatment
• Treatment with psychotropic medication that is not stable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Flexible; 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; Patient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy
Other: In-person; 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; Patient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy
Other: Telehealth; Families will only attend sessions via a secure remote video platform.	Behavioral: Team-delivered, exposure-based CBT; Patient sees licensed provider 1x/month and non-licensed provider 3x/month for exposure-based cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Top Problems Assessment- Caregiver report	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)- caregiver report	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End of Treatment Form	This form captures whether the patient ended treatment before or at 6 months, as well as the reasons for discontinuation (e.g., scheduling, transportation, financial, treatment fit, symptoms) that apply. This form also gathers information about whether referrals were provided to the family upon study discharge.	Administered only at discharge, up to 6-months into study
Reasons for Treatment Discontinuation form	This is a case record form that documents any change in patient status (e.g., drop-out and premature termination) and the reasons for such changes.	Administered only at discharge, up to 6-months into study
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.
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)
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)
Caregiver Strain Questionnaire (CSQ)	The CSQ assesses parent perceptions of the extent to which caring for a child with emotional problems affects several domains, including family life and relationships, demands on time, financial strain, disruption of social life, worry, guilt, and fatigue. This is a 21-item self-report measure that calls for parents to rate the extent of strain for each item using a 0 ("not at all") to 4 ("very much") scale.	Baseline, Week 8, Week 16 and follow-up (6 & 12 months)
Homework Compliance	Providers will rate the quality and quantity of homework between sessions	Every session- up to 24 weeks of acute treatment
Youth Top Problems Assessment	The TPA is designed to independently solicit from youth 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)
Youth 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)

Collaborators and Investigators

• Sponsor: Bradley Hospital
• Collaborators: Patient-Centered Outcomes Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: April 3, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Actual): July 31, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: cognitive behavioral therapy; exposure therapy; anxiety treatment; ERP; exposure and response prevention therapy; pediatric anxiety treatment
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Language Disorders; Speech Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Phobia, Social; Anxiety Disorders; Obsessive-Compulsive Disorder; Panic Disorder; Agoraphobia; Anxiety, Separation; Phobic Disorders; Mutism; Generalized Anxiety Disorder
• Other Study ID Numbers: BPS2023C233953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No