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

5. května 2026 aktualizováno: ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida

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

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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

60

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Maryse Guedes
  • Telefonní číslo: +351 218 811 700
  • E-mail: mguedes@ispa.pt

Studijní místa

  • Portugalsko
      • Lisbon, Portugalsko, 1149-041
        • Ispa - Instituto Universitário
        • Kontakt:
          • Maryse Guedes
          • Telefonní číslo: +351 218 811 700
          • E-mail: mguedes@ispa.pt
        • Vrchní vyšetřovatel:
          • Maryse Guedes

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ano

Popis

Inclusion criteria:

  • 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.

Exclusion criteria:

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Behaviorální: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Behavioral Inhibition Questionnaire (BIQ, Bishop et al., 2003; Fernandes et al., 2023)
Časové okno: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
The BIQ consists of 30 items that assess parent perceptions of the child's BI, considering six contexts that reflect three domains: Social Novelty (14 items), which refers to the child's inhibited behaviors toward unfamiliar adults, unfamiliar peers, and performance situations in front of others; Situational Novelty (12 items), which refers to the child's inhibited behaviors during separation and at preschool and unfamiliar situations; and Physical Activities (four items), which refers to the child's inhibited behaviors when there is a minor possible risk of injury. For each item, parents were asked to report how frequently their children displayed inhibited behaviors, using a Likert scale ranging from 1 (Almost Never) to 7 (Almost Always). Higher total scores in the BIQ indicated higher levels of child BI.
Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Emotion Regulation Checklist (ERC, Shields & Cichetti, 1997; Fernandes et al., 2024)
Časové okno: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
This teacher and parent rating scale is one of the most widely used to assess emotion regulation of children in preschool and school-age children. The ERC consists of 24 itens, answered in a a 4-point Likert response (1=never, 2=sometimes, 3=often, 4=almost always). The ERC comprises two subscales: Emotion Regulation, that includes 8 items measuring adaptive regulation processes, such as socially appropriate emotional displays and empathy; and Emotional Lability/Negativity, that includes 15 items assessing mood lability, inflexibility, dysregulated negative affect, and inappropriate affective displays. Higher scores in the Emotion Regulation subscale indicate greater emotion regulation capacity, whereas higher scores in Emotional Lability/Negativity reflect greater emotional dysregulation.
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)
Časové okno: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
This 30-item rating scale assessed parent perceptions about the affective quality of the relationships that children aged 30-78 months establish with peers and significant adults in context. This rating scale has been widely used in different cultures and provides a standardized description of affect and behavior in context, discriminating behavioral-emotional problems and social adjustment. Items were answered using a 6-point Likert scale, ranging from 1 (never) to 6 (always). The SCBE-30 consists of three scales with 10 items each: Anger-Aggression, referring to externalizing behaviors; Anxiety-Withdrawal, encompassing internalizing behaviors; and Social Competence, assessing prosocial behaviors.
Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Student-Teacher Relationship Scale-Short Form (STRS-SF, Pianta, 1992; Patrício et al., 2015)
Časové okno: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
This teacher rating scale is composed of a total of 15 items, of which 7 items evaluate closeness and 8 items evaluate conflict in the student-teacher relationship. For each item the teacher rates the degree to which the item applies to his relationship with one individual student, from 1 (definitely does not apply) to 5 (definitely applies). The raw scores consist of the sum of item responses. Therefore, the closeness dimension can vary between 7 and 35 and the conflict dimension can vary between 8 and 40. The total score of the STRS consists on the sum of all the items (with the items of the conflict dimension inverted) and varies between 15 and 75.
Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Preschool Play Behavior Scale (PPBS, Coplan & Rubin, 1998; Monteiro et al., 2017)
Časové okno: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
This 18-item teacher rating scale, answered using a 5-point Likert scale (1 = never to 5 = very frequently), describes the behaviors of preschool-aged children, which can be observed in a free-play context with peers. The PPBS comprises three dimensions that refer to different types of non-social behavior: (1) Reticent Behavior, consisting of four items referring to behaviors such as observing peers without interacting or being unoccupied; (2) Solitary-Passive Behavior, consisting of four items related to constructive and exploratory solitary behaviors; and (3) Solitary-Active Behavior, consisting of two items referring to dramatic solitary behaviors. Additionally, there are two dimensions that capture a broader range of play behaviors: (4) Social Play, consisting of six items related to group play, socio-dramatic play, and conversations with peers; and (5) Rough-and-Tumble Play, consisting of two items involving physical play behaviors, such as playful fighting.
Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Parent-Teacher Relationship Quality Scale-II (Vikers & Minke, 1995)
Časové okno: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
This 24-item teacher and parent rating scale assesses parent-teacher joining (representing parent-teacher affiliation, support, dependability, availability, shared expectations, and beliefs) and communication (representing the need to express oneself to the other). Items are rated on a 5-point scale (1 = strongly disagree to 5 = strongly agree). Higher scores reflect more positive/collaborative parent-teacher relations.
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)
Časové okno: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
This 21-item self-report questionnaire intends to assess negative affective states in adults. The DASS-21 is organized into three subscales, each comprising seven items: Depression; Anxiety, and Stress. Respondents are asked to answer each of the presented items, considering the past week, using a 4-point Likert scale (1 = did not apply to me at all to 4 = applied to me most of the time). Scores for each scale are calculated by summing the responses to the seven items. Higher scores on each scale correspond to more negative affective states.
Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Enrollment rate
Časové okno: During recruitment period (up to study start, Week 0)
Enrollment rate will be measured as the proportion of eligible individuals contacted who consent to participate during the recruitment period (prior to Week 0).
During recruitment period (up to study start, Week 0)
Retention rate
Časové okno: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Retention rate will be measured as the proportion of participants who completed the post-intervention assessment (Week 18) among those assessed at baseline (Week 0).
Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Intervention Adherence
Časové okno: Throughout the intervention period (Week 1 to Week 18)
Intervention adherence will be measured by the mean number of sessions attended by early education professionals (range: 0 to 18 sessions).
Throughout the intervention period (Week 1 to Week 18)
Practice Activities Adherence
Časové okno: Throughout the intervention period (Week 1 to Week 18)
Practice activities' adherence will be measured by the mean number of between-session practice activities completed (range: 0 to 18 activities)
Throughout the intervention period (Week 1 to Week 18)
Weekly Satisfaction Questionnaire
Časové okno: Throughout the intervention period (Week 1 to Week 18)
Mean weekly satisfaction scores will be calculated from repeated weekly questionnaires completed by early childhood education professionals during the intervention period (Week 1 to Week 18).
Throughout the intervention period (Week 1 to Week 18)
Fidelity Outcome Measure
Časové okno: Throughout the intervention period (Week 1 to Week 18)
Intervention fidelity will be measured as the percentage of session content and activities implemented as intended, based on intervener-rated checklists.
Throughout the intervention period (Week 1 to Week 18)
Final Satisfaction Questionnaire
Časové okno: Immediately post-intervention (T2, Week 18)
Mean final satisfaction scores will be calculated from the final satisfaction questionnaire completed by early childhood education professionals at Week 18.
Immediately post-intervention (T2, Week 18)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

1. července 2027

Dokončení studie (Odhadovaný)

1. září 2027

Termíny zápisu do studia

První předloženo

21. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

28. dubna 2026

První zveřejněno (Aktuální)

5. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

5. května 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • I-063-11-2021
  • 11405/CML/2025 (Jiné číslo grantu/financování: Câmara Municipal de Lisboa)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Intellectual Property Data (IPD) might not be shared due to concerns about confidentiality and legal restrictions. Sharing it could risk exposing proprietary or sensitive information, including details that may affect participants' privacy.

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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