AnxietyBrave_ElephantNCT07567820
Feasibility and Preliminary Outcomes of the Brave Elephant Program: A Single-Arm Pretest-Posttest Study
A study testing Brave Elephant Program in people with Anxiety, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Brave Elephant Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Children's developmental disorders
- Children's, parents' and early education professionals' are enrolled in another psychological intervention.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Ispa - Instituto Universitário
Lisbon, 1149-041
Maryse Guedes, +351 218 811 700, mguedes@ispa.pt
Maryse Guedes
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Anxiety
- Being tested
- Brave Elephant Program
- Keywords
- Behavioral inhibition, Preschool age, Teacher-child relationship, Peer play, Teacher-parent relationship, Teacher mental health
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brave Elephant ProgramBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Brave Elephant Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Preschool Play Behavior Scale (PPBS, Coplan & Rubin, 1998; Monteiro et al., 2017)
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.
Measured: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Parent-Teacher Relationship Quality Scale-II (Vikers & Minke, 1995)
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.
Measured: 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)
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.
Measured: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567820
- Sponsor's protocol ID
- I-063-11-2021
- Other IDs
- 11405/CML/2025
- Acronym
- Brave_Elephant
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Outcomes of the Brave Elephant Program: A Single-Arm Pretest-Posttest Study in Early Childhood Education Settings
- ClinicalTrials.gov ID
- NCT07567820
- Acronym / sponsor ID
- Brave_Elephant / I-063-11-2021
- Conditions
- Anxiety
- Keywords
- Behavioral inhibition, Preschool age, Teacher-child relationship, Peer play, Teacher-parent relationship, Teacher mental health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da VidaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brave Elephant Program | Experimental | Behavioral: Brave Elephant ProgramThe Brave Elephant Program is a multicomponent intervention delivered over 18 weeks targeting early childhood education professionals, preschool children and their parents. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Children's developmental disorders
- Children's, parents' and early education professionals' are enrolled in another psychological intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brave Elephant ProgramThe 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. | Behavioural | Brave Elephant Program |
Primary outcome
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)
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.
Emotion Regulation Checklist (ERC, Shields & Cichetti, 1997; Fernandes et al., 2024)
Time frame: 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.
Social Competence and Behavior Evaluation Scale-30 (SCBE-30, LaFreniere & Dumas, 1996; Fernandes et al., 2020)
Time frame: 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.
4 secondary outcomes
Student-Teacher Relationship Scale-Short Form (STRS-SF, Pianta, 1992; Patrício et al., 2015)
Time frame: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Preschool Play Behavior Scale (PPBS, Coplan & Rubin, 1998; Monteiro et al., 2017)
Time frame: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Parent-Teacher Relationship Quality Scale-II (Vikers & Minke, 1995)
Time frame: 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)
Time frame: Baseline (T1, Week 0) and immediately post-intervention (T2, Week 18)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brave Elephant Program in people with Anxiety, run by ISPA - Instituto Universitario de Ciencias Psicologicas, Sociais e da Vida at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryse Guedes (+351 218 811 700, mguedes@ispa.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.