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

Sponsor
ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
Study ID
NCT07567820
Status
Not Yet Recruiting

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Conditions

  • Anxiety

Eligibility Criteria

Sex
ALL
Age
3 Years - 6 Years
Healthy Volunteers
Accepted

Interventions

  • Brave Elephant Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

First listed
May 5, 2026
Start date
Sep 30, 2026
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Brave Elephant Program
    The Brave Elephant Program is a multicomponent intervention delivered over 18 weeks targeting early childhood education professionals, preschool children and their parents.

Primary Outcome Measure

Behavioral Inhibition Questionnaire (BIQ, Bishop et al., 2003; Fernandes et al., 2023) [ Time Frame: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18) ]

Central Contacts

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