Clinical Trial

Feasibility and Preliminary Outcomes of the Brave Elephant Program: A Single-Arm Pretest-Posttest Study

Study acronym: Brave_Elephant
Not Yet Recruiting
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Summary
Anxiety disorders are highly prevalent in childhood and have increased following the COVID-19 pandemic. Behavioral inhibition in early childhood is a well-established risk factor for later anxiety. School-based preventive interventions that target both classroom environments and individual child characteristics may help reduce early risk and improve socioemotional development. Interventions delivered in preschool settings that address the needs of behaviorally inhibited children, while also supporting professional development, may improve the quality of interactions within the classroom and with families, and promote positive developmental outcomes. The Brave Elephant Program is an evidence-based intervention grounded in a bioecological developmental framework. It aims to empower early childhood education professionals to promote socioemotional competence and resilience in all children, while addressing the specific needs of behaviorally inhibited preschoolers and enhancing educators' professional development. This study will evaluate the feasibility, acceptability, and preliminary outcomes of the program using a single-arm pretest-posttest design.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-28.
Trial Details
NCT Number NCT07567820
Lead Sponsor ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Conditions Anxiety
Enrollment 60 participants
Start Date 2026-09
Primary Completion 2027-07 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-08