Project Summary

PCORI has identified the need for large studies that look at real-life questions facing diverse patients, caregivers, and clinicians. In 2014, PCORI launched the Pragmatic Clinical Studies initiative to support large-scale comparative effectiveness studies focusing on everyday care for a wide range of patients. The Pragmatic Clinical Studies initiative funded this research project and others.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

About 4.4 million youth ages 3 to 17 have an anxiety disorder. Youth with anxiety disorders may have unfounded fears, trouble separating from their parents, a hard time sleeping, or obsessive thoughts. They may also have physical symptoms like sweating, shortness of breath, or stomachaches. Cognitive behavioral therapy, or CBT, is one kind of treatment for anxiety disorders. In CBT, youth learn about their anxiety and strategies for overcoming it.

Most youth with anxiety disorders don’t get treatment. They may have a hard time getting to appointments or may avoid mental health treatment because they have negative beliefs about it. A lack of therapists may make it difficult for them to find treatment. Youth who are from minority backgrounds or from families with low incomes may have an especially hard time getting treatment.

In this study, the research team wants to know if offering CBT through an online program is similar to having in-person sessions with a therapist in improving anxiety symptoms. The research team also wants to know if the severity of anxiety, how far they live from a clinic, or other factors affect how youth do with online or in-person CBT.

Who can this research help?

This research can help youth and their doctors when considering treatment options for anxiety disorders. Health clinics can use the study’s results when considering services for youth with anxiety disorders.

What is the research team doing?

The research team is recruiting 1,856 youth ages 3 to 18 with anxiety disorders receiving care from clinics across the United States. The team is assigning youth to one of two groups by chance. The first group is receiving eight sessions of online CBT with phone support from a therapist every two weeks. The second group is receiving eight in-person CBT sessions with a therapist. Both groups complete the CBT in four months or less. Therapy in both groups is available in English or Spanish.

Youth or their parents are filling out surveys when they first start CBT and six weeks, three months, one year, and two years after treatment. The surveys ask questions about symptoms of fear, anxiety, and stress; behaviors to avoid fear; and how much anxiety interferes with their life.

Youth with anxiety disorders and their parents, mental health professionals, and other partners are working with the research team to help plan the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population Children ages 3–18 with elevated anxiety at the time of screening 
Interventions/
Comparators
  • Web-based CBT
  • In-person CBT
Outcomes

Primary: fear, anxiety, misery, hyper-arousal, somatic symptoms related to arousal, behavioral fear avoidance, life interference and impairment associated with anxiety 

Secondary: parents’ beliefs and attitudes about technology; therapist attitudes toward adoption of evidence-based practices; report of psychosocial problems by doctor; report of organizational readiness for change by staff; youth reports of depression, anxiety, stress, value of services received; barriers to treatment participation; technological ease and computer-based habits; youth program attendance and homework compliance; beliefs about child anxiety

Timeframe Up to 2-year follow-up for primary outcomes 

Project Information

Donna Pincus
Boston Medical Center Corporation
$6,099,553
KIDS FACE FEARS: Face-to-face vs. Computer-Enhanced Formats Pragmatic Study of Anxiety

Key Dates

April 2018
March 2024
2018

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022