Recruiting

Cultural Adaptation

Sponsor:

University of Miami

Code:

NCT04729504

Conditions

Anxiety Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Adapted Project BRAVE

Study Details

Brief summary:

The overarching objective of this protocol is to (1) adapt and (2) disseminate an evidence-based, brief (approximately 30 minute) single session intervention (SSI) to better reflect the cultural and linguistic diversity of Latin, Haitian, and Haitian-American individuals via a fully online platform.

Conditions

Anxiety Disorders

Study ID

NCT04729504

Start date

Mar 8, 2021

Status verified date

Dec, 2025

Completion date

Dec 21, 2026

Anticipated

Primary completion date

Dec 21, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Be caregivers (e.g. biological or adoptive parent, or legal guardian) of a child age 4-10.
2. Affirm that they have read the consent language and study overview on REDCap by checking a box.

Exclusion Criteria:

\- Not meet all of the inclusion criteria.

Study Design

Enrollment

2000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Adapted Project BRAVE Group

Participants in this group will receive a single session intervention of a culturally and linguistically adapted Project BRAVE.

Interventions

Adapted Project BRAVE

A culturally and linguistically adapted Project BRAVE is web-based single session intervention that is about 30 minutes in length. The session is designed to focus on targeting child anxiety symptoms in the multilingual and diverse families in Miami-Dade.

Primary outcome measure

  • Change in anxiety as measured by GAD-2 [ Time Frame: Baseline, 2 weeks ]
  • Change in anxiety as measured by the FASA [ Time Frame: Baseline, 2 weeks ]
  • Program Feedback Scale (PFS) Scores [ Time Frame: 2 weeks ]

Central Contacts and Locations

Central contacts

Hannah Grassie, BA

305-284-2712hlg54@miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Hannah Grassie

305-284-2712hlg54@miami.edu

Principal Investigator:

Jill Ehrenreich-May

More Information

Sponsor

University of Miami

Last update posted

Dec 18, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2025-12-18.