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Clinical Trials/NCT04729504
NCT04729504RecruitingNot Applicable

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

University of Miami2 sites in 1 country2,000 target enrollmentStarted: March 8, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
2,000
Locations
2
Primary Endpoint
Change in anxiety as measured by the FASA

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Change in State Hope Scale Scores(Baseline, 2 weeks)
  • Perceived Change in Problem-Solving, and Preparedness to Manage Distress(2 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jill May Ehrenreich

Professor, Department of Psychology

University of Miami

Study Sites (2)

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