Measuring What Matters: Development and Implementation of a Core Outcome Set (COS) for Child and Adolescent Anxiety Disorders

Anxiety disorders are one of the most prevalent mental health disorders in children and adolescents. No core outcome set (COS) exists for clinical trials of child and adolescent anxiety disorders, despite their high prevalence and significant morbidity and mortality. The aim of this study is to develop an evidence- and consensus-based COS for child and adolescent anxiety clinical trials by following COS development methodology recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) Initiative. Innovative adaptations to engage patients and caregivers will be employed thereby ensuring that patient-centric outcomes that matter to patients themselves are incorporated into the COS.


Principal investigators: Dr. Suneeta Monga
Co-investigators: Dr. Nancy Butcher, Dr. Martin Offringa, Dr. Peter Szatmari, Dr. Darren Courtney, Dr. Kristin Cleverley, Dr. Alexa Bagnell, Dr. Paul Arnold, Dr. Elizabeth Potter, Dr. Karolin Krause, Dr. Scott Patten, Dr. Gina Dimitropoulos, Dr. Evelyn Stewart, Dr. Leslie Campbell
Contributors: Riddhi Desai
Affiliations: The Hospital for Sick Children

Further Study Information

Current Stage: Ongoing
Date: October 2020 - April 2024
Funding source(s): To be confirmed

Health Area

Disease Category: Mental health

Disease Name: Anxiety

Target Population

Age Range: 4 - 18

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Epidemiologists
- Ethicists
- Governmental agencies
- Journal editors
- Methodologists
- Regulatory agency representatives
- Researchers
- Service providers
- Statisticians

Study Type

- COS for clinical trials or clinical research


- Consensus meeting
- Delphi process
- Focus group(s)
- Interview
- Survey
- Systematic review

Development of this COS will follow Core Outcome Set-STAndards for Development (COS-STAD) guidelines. To identify existing knowledge about outcomes in child and adolescent anxiety disorders and establish the need for a COS, a systematic scoping review will be conducted. Once outcomes are mapped to an outcome-related framework (e.g., OMERACT filter 2.0), a Delphi process will be conducted to determine which outcomes are core or essential to retain for final discussion at a face-to-face consensus meeting and patient/caregiver interviews. At these final discussions, outcomes will be selected to include in the final COS.