Status:
ACTIVE_NOT_RECRUITING
Addressing Anxiety in 2-3-Year-Olds: A Pilot Intervention Study
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Anxiety Disorder of Childhood
Fear
Eligibility:
All Genders
21-47 years
Phase:
NA
Brief Summary
The purpose of this study is to test the feasibility and efficacy of intervening with 2-year-old children with elevated temperamental Fear and/or Shyness or 3-year-old children with elevated anxiety a...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04039243
Start Date
September 27 2019
End Date
January 1 2026
Last Update
August 29 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114