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

NCT07567820 | Not Yet Recruiting

• 2 other identifiers: I-063-11-202111405/CML/2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Anxiety

Keywords

Behavioral inhibition; Preschool age; Teacher-child relationship; Peer play; Teacher-parent relationship; Teacher mental health

Outcome Measures

Primary Outcomes (3)

• Behavioral Inhibition Questionnaire (BIQ, Bishop et al., 2003; Fernandes et al., 2023)

  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)

  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)

  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)

Secondary Outcomes (4)

• Student-Teacher Relationship Scale-Short Form (STRS-SF, Pianta, 1992; Patrício et al., 2015)

  Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)

• Preschool Play Behavior Scale (PPBS, Coplan & Rubin, 1998; Monteiro et al., 2017)

  Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)

• Parent-Teacher Relationship Quality Scale-II (Vikers & Minke, 1995)

  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)

  Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)

Other Outcomes (7)

• Enrollment rate

  During recruitment period (up to study start, Week 0)

• Retention rate

  Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)

• Intervention Adherence

  Throughout the intervention period (Week 1 to Week 18)

Study Arms (1)

Brave Elephant Program

EXPERIMENTAL

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

Behavioral: Brave Elephant Program

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.

Brave Elephant Program

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Ispa - Instituto Universitário

Lisbon, 1149-041, Portugal

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Maryse Guedes

CONTACT

+351 218 811 700; mguedes@ispa.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)