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

Официальное название

Feasibility and Preliminary Outcomes of the Brave Elephant Program: A Single-Arm Pretest-Posttest Study in Early Childhood Education Settings

Обзор

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.

Подробное описание

Aims and hypotheses: Given the relative novelty of this intervention, conducting a single-arm pre-post study of feasibility and preliminary outcomes is warranted. The aims of this single-arm trial will be to: (1) examine whether the Brave Elephant Program can be delivered with feasibility and fidelity and is acceptable for the targeted groups, and (2) investigate whether the intervention program is associated with pre-post improvements in primary (child) and secondary (teacher and interpersonal) outcomes, particularly among preschoolers who display high levels of baseline behavioral inhibition.

For the first aim, it is expected that intervention fidelity will be greater than or equal to 80%. Attendance of early childhood education professionals is expected to be greater than or equal to 90%, and adherence to between-sessions practice activities is expected to be at least 85%. Regarding acceptability, it is expected that early childhood education professionals, parents, and children will consider the intervention goals relevant, perceive the contents, activities, and materials as useful, report high levels of satisfaction, and suggest only minor modifications.

For the second aim, it is expected that preschool children will show a decrease in internalizing behaviors and an increase in emotion regulation and social competence from pre- to post-intervention. These improvements are anticipated to be more pronounced among children who display higher levels of anxious withdrawal at baseline. With respect to secondary outcomes, an improvement in the quality of teacher-child relationships, parent-teacher relationships and peer play is expected from pre- to post-intervention assessments, particularly for children with high behavioral inhibition. Additionally, it is expected that early childhood education professionals will report reductions in anxiety, depression and stress symptoms from pre- to post-intervention assessments.

Вмешательства

• Поведенческое 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

Первичные конечные точки

• Behavioral Inhibition Questionnaire (BIQ, Bishop et al., 2003; Fernandes et al., 2023) [Срок оценки: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)]
• Emotion Regulation Checklist (ERC, Shields & Cichetti, 1997; Fernandes et al., 2024) [Срок оценки: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)]
• Social Competence and Behavior Evaluation Scale-30 (SCBE-30, LaFreniere & Dumas, 1996; Fernandes et al., 2020) [Срок оценки: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)]

Вторичные конечные точки (4)

• Student-Teacher Relationship Scale-Short Form (STRS-SF, Pianta, 1992; Patrício et al., 2015) [Срок оценки: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)]
• Preschool Play Behavior Scale (PPBS, Coplan & Rubin, 1998; Monteiro et al., 2017) [Срок оценки: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)]
• Parent-Teacher Relationship Quality Scale-II (Vikers & Minke, 1995) [Срок оценки: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)]
• Depression Anxiety Stress Scales (DASS-21, Lovibond & Lovibond, 1995; Pais-Ribeiro et al., 2004) [Срок оценки: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)]

Критерии участия

Критерии включения

• Children's age between 3 and 6 years
• Parents' written informed consent for children's participation in the study.
• Children's informed assent to participate in the study.
• Parents' ability to read and understand Portuguese.
• Early childhood and care professionals' ability to read and understand Portuguese
• Early childhood and care professionals' full-time contract for the school year.

Критерии исключения

• Children's developmental disorders
• Children's, parents' and early education professionals' are enrolled in another psychological intervention.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Португалия · 1 центр

• Ispa - Instituto Universitário — Lisbon

Идентификаторы

NCT: NCT07567820 · I-063-11-2021 · 11405/CML/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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