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?

More than one in five youth have anxiety, which can negatively affect school performance and relationships with friends and family. Both therapy and medicine are effective treatments for anxiety. But questions remain about which treatment to start with. Also, for some patients, therapy or medicine may not work well at first. When this happens, doctors don’t know the best way to respond. For example, if medicine doesn’t relieve a patient’s symptoms, doctors could increase the dose or add therapy.

In this study, the research team is comparing different ways to treat anxiety in youth. One way is cognitive behavioral therapy, or CBT. CBT is a type of talk therapy. In CBT, patients learn to change patterns in their thinking to improve how they feel. The other way is fluoxetine, a medicine to treat anxiety.

The research team wants to learn if it is more effective to start treatment with CBT or medicine. For patients who need to adjust their treatment plans, the team wants to see if it’s more effective for doctors to increase the dose of the first treatment or use a combined treatment approach. Also, the team is looking to see if outcomes differ based on whether patients receive one treatment continuously or change treatments during the study.

Who can this research help?

Results may help youth, caregivers, and doctors when considering ways to treat anxiety among youth.

What is the research team doing?

The research team is enrolling 404 youth ages 8–17 who have an anxiety disorder. The team is assigning youth by chance to receive either CBT or medicine for 12 weeks. After 12 weeks, the team is assigning youth who are still having anxiety symptoms to one of two groups by chance. In the first group, the treatment dose increases, with youth who first received medicine receiving a higher dose and youth who first received CBT receiving CBT more often. In the second group, youth receive both CBT and medicine.

The research team is surveying youth and caregivers to assess anxiety symptoms at the start of the study and again 3, 6, and 12 months later.

Youth, caregivers, and clinicians are helping to plan and conduct this study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population 404 youth ages 8–17 with an anxiety disorder

Weeks 1–12:

  • CBT alone
  • Fluoxetine alone

Weeks 13–24 (if the initial treatment in stage 1 fails to fully improve anxiety symptoms):

  • Intensification of initial treatment
  • A combination of CBT and fluoxetine

Primary: youth anxiety symptom severity

Secondary: youth-rated functional impairment due to anxiety; caregiver-rated anxiety symptom severity and functional impairment of youth

Timeframe 12-month follow-up for primary outcome

Project Information

Bradley S. Peterson, MD
Children's Hospital Los Angeles
A Sequential Multiple Assignment Randomized Trial (SMART) Assessing Medication and CBT Sequencing Strategies in the Treatment of Predominantly Ethnic Minority, Underserved Youth with Anxiety Disorders

Key Dates

November 2019
September 2025

Study Registration Information


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: September 26, 2023