Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 29, 2019
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how to help young children, specifically those aged 2 to 3 years old, who are experiencing anxiety, fear, or shyness. The researchers want to see if a special therapy called Cognitive Behavioral Therapy (CBT) can help reduce these feelings of anxiety in children and if these benefits last for a year after treatment. Since the COVID-19 pandemic, all sessions are now conducted online, making it easier for families to participate from home.
To be eligible for this study, children need to show higher-than-normal levels of fear or shyness. For example, if a 2-year-old scores significantly higher than other children on a behavior questionnaire, they might qualify. Parents must be comfortable speaking and understanding English, and children should have some knowledge of English too. However, children with certain conditions, like Autism Spectrum Disorder or severe behavioral issues, cannot participate. Families who join the study can expect to work closely with therapists and will be guided through the CBT process to help improve their child's anxiety.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • The child scores \>1 Standard Deviation (SD) above reported means for the Fear or Shyness scales on the Early Childhood Behavior Questionnaire (ECBQ) (if child is 21-35 months) or the child scores \>1SD above reported means for the Total Anxiety, Generalized Anxiety, Social Anxiety, Physical Injury Fears, or Separation Anxiety scales on the Preschool Anxiety Scale (PAS) (if child is 36-47 months) as completed by a parent
- • The parents are able to speak, understand, and read English
- • The child must have a working knowledge of English.
- Exclusion Criteria:
- • Autism Spectrum Disorder (ASD) or global developmental delay in the child
- • The child has disruptive behavior so severe as to interfere with participation in intervention sessions
- • The child has a different primary disorder for which CBT for anxiety is inappropriate (e.g. severe depression, depression in the mother, significant medical disorder).
About Massachusetts General Hospital
Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Patients applied
Trial Officials
Dina Hirshfeld-Becker, PhD
Principal Investigator
Massachusetts General Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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