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NCT Number: NCT04729504

Cultural Adaptation of a SSI for Youth Anxiety

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.

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Key information

Conditions

Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Hannah Grassie

CONTACT

[email protected]

305-284-2712

Jill Ehrenreich-May

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Be caregivers (e.g. biological or adoptive parent, or legal guardian) of a child age 4-10.
  • 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.

Treatment and study plan

Adapted Project BRAVE

Behavioral

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 outcomes

  1. Change in anxiety as measured by GAD-2

    Time frame: Baseline, 2 weeks

    Generalized Anxiety Disorder 2-item (GAD-2) Scale has a total score ranging from 0 to 6 with a score of 3 being the cut-off for identifying possible cases and in which further diagnostic evaluation for generalized anxiety disorder is warranted.

  2. Change in anxiety as measured by the FASA

    Time frame: Baseline, 2 weeks

    Family Accommodation Scale - Anxiety (FASA) is a 9-item scale of measuring caregiver accommodation behaviors (modification of routines, facilitating avoidance, etc.) in light of youth anxiety. It has a total score ranging from 0 to 36 with the higher score indicating more frequent parental accommodation.

  3. Program Feedback Scale (PFS) Scores

    Time frame: 2 weeks

    The PFS is a reliable, valid measure of the perceived acceptability of single-session interventions. It asks participants to rate acceptability and feasibility of an SSI they just completed. It has a total score ranging from 0 to 28 with the higher score indicating perceived acceptability and feasibility of the program.

Secondary outcomes

  1. Perceived Change in Problem-Solving, and Preparedness to Manage Distress

    Time frame: 2 weeks

    Two questions (Schleider et al., 2020) will be used to assess change in ability to solve problems, and ability to manage distress. Participants will be asked, "to what extent are you able to solve the problems [with your child's anxiety] facing right now?", and "how prepared do you feel to manage [your child with] distressing situations?" It has a total score ranging from 2 to 10, with a higher score indicating better ability to solve problems, and to manage distress.

  2. Change in State Hope Scale Scores

    Time frame: Baseline, 2 weeks

    State Hope Scale is a 6-item self-report scale designed to evaluate hope in adolescents and adults, including two reliable subscales: agency and pathways. It has a total score ranging from 6 to 48 with the higher scores representing higher hope levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Grassie, BA

CONTACT

[email protected]

305-284-2712

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Cultural Adaptation and Dissemination of a Single-Session Intervention (SSI) Targeting Caregivers of Youth With Anxiety

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 28, 2021
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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