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Recruiting NCT04729504

Cultural Adaptation of a SSI for Youth Anxiety

No phase Interventional Anxiety Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adapted Project BRAVE.
Who it may be relevant to
Registry conditions: Anxiety Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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 measures

  • 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]
Secondary outcome measures (2)
  • Perceived Change in Problem-Solving, and Preparedness to Manage Distress [Time frame: 2 weeks]
  • Change in State Hope Scale Scores [Time frame: Baseline, 2 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT04729504 · 20210016

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗