Project Summary

PCORI has identified anxiety in young people as an important research topic. Patients, clinicians, and others want to learn: Which treatments, alone or in combination, work best to treat anxiety in children and young adults between 7 and 25 years of age? To address this issue, PCORI launched an initiative in 2019 on Treatment of Anxiety Disorders in Children, Adolescents, and/or Young Adults. The initiative funded this research project and one other.

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?

Youth with anxiety disorders may have intense, persistent feelings of worry or fear about doing routine activities. These feelings can get in the way of relationships or daily activities such as school. If left untreated, anxiety can continue to affect youth into adulthood.

One way to treat anxiety disorders is with cognitive behavioral therapy, or CBT. In CBT, patients learn to change patterns in their thinking and behavior. Another way to treat anxiety disorders is with antidepressant medicine. In past studies, using CBT and medicines together was more effective than using either treatment alone. But past studies tested CBT that had a limited number of sessions over a short time. Past studies also limited how much patients’ families were involved. These limits may have made the CBT less effective.

In this study, the research team is comparing two ways to treat anxiety disorders in youth. One way includes CBT that has more sessions over a longer timeframe. This way also involves patients’ families more than in past studies. The other way is using this same kind of CBT plus medicine.

Who can this research help?

Results may help young patients, families, and doctors who are considering ways to treat anxiety.

What is the research team doing?

The research team is enrolling 468 patients ages 7–17 with anxiety. Patients are attending primary care clinics in Chicago, Los Angeles, and Cincinnati. The team is assigning patients by chance to receive CBT alone or CBT with one of three antidepressant medicines that work to treat anxiety disorders.

Patients and their caregivers receive up to 20 CBT sessions with a community therapist over six months. During the CBT, patients learn to manage symptoms of anxiety and take part in routine activities that cause fear or worry. Caregivers learn about anxiety disorders and how they can help their child cope with symptoms.

All patients and caregivers are completing monthly online surveys during the six months of treatment, then every other month for six more months. The surveys ask about symptoms of the anxiety disorder and ability to function in school, at home, and with friends.

Patients, caregivers, community members, pediatricians, therapists, teachers, policy makers, and health insurers are helping to plan and conduct this study. They are helping to make sure that youth and their families can easily take part.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 468 children and adolescents ages 7–17 who were diagnosed with an anxiety disorder that was identified in pediatric primary care clinics in Chicago, Los Angeles, and Cincinnati, and their caregivers
Interventions/
Comparators
  • CBT
  • CBT plus a selective serotonin reuptake inhibitor  
Outcomes

Primary: anxiety disorder remission 6 months after the first treatment, anxiety disorder symptoms’ impact on children’s functioning 6 months after treatment

 Secondary: anxiety disorder remission 12 months after the first treatment, anxiety symptoms’ impact on children’s functioning 12 months after treatment 

Timeframe 6-month follow-up for primary outcomes

Project Information

John T. Walkup, MD
Ann & Robert H. Lurie Children's Hospital of Chicago
$6,241,250
Partners in Caring for Anxious Youth (PCAY)

Key Dates

November 2019
June 2025
2019

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