This multi-year national study is the largest multisite clinical trial to examine face-to-face and internet-based therapy for children with anxiety. Researchers at the Center for Children and Families will evaluate treatment of anxiety in nearly 2,000 children and adolescents ages 3 to 18 across four regions of the United States. The total funding award is for more than $10 million across the four sites. Data collection and result analyses will be centralized at FIU with the Center for Children and Families serving as the main data and biostatical hub of the project.
Psychologists Jonathan Comer and Dana McMakin will lead the FIU research team. In collaboration with Nicklaus Children’s Hospital, researchers will compare the effectiveness of face-to-face versus online therapy; analyze the factors that determine which method of delivery works best for each patient and health care provider; and collaborate with patients, families and providers to implement those methods.
“Nicklaus Children’s is pleased to collaborate with FIU to explore methods of enhancing access to treatment for children with anxiety disorders,” said Sara Rivero-Conil, psychologist and clinical manager at Nicklaus Children’s Division of Psychology. “This protocol fulfills an organizational commitment to advancing outreach and research to meet the needs of children from our region and beyond.”
The study was selected for funding through PCORI’s Pragmatic Clinical Studies Initiative. This initiative is an effort to produce results broadly applicable to a diverse range of patients and care situations and that can be quickly implemented in clinical practice.
“Pediatric anxiety is a highly prevalent, but also highly treatable, condition,” said Comer, director of the Mental Health Interventions and Technology Program at FIU’s Center for Children and Families. “This study has great potential to meaningfully improve mental health care for a significant proportion of the population.”
Many clinical studies test whether a treatment works under ideal conditions in specialized research centers, but health care is rarely delivered in such idealized settings. Pragmatic clinical studies test a treatment’s effectiveness in “real-life” practice situations including hospitals and outpatient clinics allowing for a wider range of study participants and making findings more generally applicable.
The FIU study was selected through a highly competitive review process in which patients, caregivers and other stakeholders joined scientists to evaluate the proposals. In addition to FIU and Nicklaus Children’s Hospital, this multisite study includes Boston University and Boston Medical Center; the University of Washington and Seattle Children’s Hospital; Johns Hopkins University and Hospital; and Macquarie University in Sydney, Australia.
FIU’s award has been approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. For more information about PCORI’s funding, visit www.pcori.org.