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

NCT07567820 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-08

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

Brave Elephant Program

The Brave Elephant Program is implemented across three parallel components. The professional component is delivered by two trained psychologists through psychoeducational workshops and individualized classroom coaching sessions. This component focuses on understanding behavioral inhibition, promoting positive relationships, emotional regulation, social engagement and social problem-solving. The child component is delivered by early education professionals in the classroom through age-appropriate didactic activities (e.g., modeling/role-play, mindfulness activities, and supervised free play with adults and peers to enhance socioemotional competence. The family component is also delivered by early education professionals, by sharing the materials and activities that are implemented in the classroom with parents to promote skill generalization across contexts.

Sponsors & Collaborators

  • ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-07-31
Completion
2027-09-30

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07567820 on ClinicalTrials.gov