Skip to main content
Clinical Trials/NCT05426057
NCT05426057
Recruiting
N/A

Scaling a Parenting Evidence Based Intervention (EBI) for Latinx Youth Mental Health in Primary Care

University of Miami17 sites in 1 country468 target enrollmentApril 26, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression, Anxiety
Sponsor
University of Miami
Enrollment
468
Locations
17
Primary Endpoint
Depression symptoms
Status
Recruiting
Last Updated
8 months ago

Overview

Brief Summary

The goal of this study is to evaluate in an effectiveness-implementation type I hybrid trial, an enhanced version of eHealth Familias Unidas for reducing depressive, anxious symptoms and suicide behavior in Hispanic youth. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.

Registry
clinicaltrials.gov
Start Date
April 26, 2022
End Date
November 30, 2026
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guillermo Prado

Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Female and male adolescents, who self-identify as Hispanic (or Latino(a))
  • Adolescent between the ages of 12 - 16 years
  • Adolescent living with an adult primary caregiver who is willing to participate
  • Families must have broadband internet access on a device, including (but not limited to) a smartphone, iPad, tablet, computer at their home or other location (e.g., school, library, etc.)
  • Families screening positive on poor family communication (a score of less than 75 on the communication measure; see measures) or youth reporting elevated depressive or anxiety symptom scores (defined as 70 to 90 on the K-CAT) or a history of suicide behavior (ideation or attempts).

Exclusion Criteria

  • Families reporting plans to move out of the South Florida area during the study period.

Outcomes

Primary Outcomes

Depression symptoms

Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Change in depression symptom severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater depression symptom severity.

Center for Epidemiologic Studies Depression Scale (CESD)

Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Change in depression symptoms will be assessed with the CESD. Scores range from 0 to 60 with higher scores indicating the presence of more symptoms.

Anxiety symptoms

Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Change in anxiety symptom severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater anxiety symptom severity.

Suicidality

Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Change in suicidality severity will be measured using the Kiddie Computerized Adaptive Test (K-CAT®). K-CAT® measures severity on a scale of 0 to 100 with higher scores indicating greater suicidality symptom severity.

Change in drug use

Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months

Change in drug use will be reported as the number of days drug use was reported over the last 90 days.

Secondary Outcomes

  • Change in Family Functioning as assessed by the Parent Relationship with Peer Group(Baseline to 3 months, baseline to 6 months, baseline to 18 months)
  • Change in unprotected sexual behavior(Baseline to 3 months, baseline to 6 months, baseline to 18 months)
  • Change in Family Functioning as assessed by the Parenting Practices Questionnaire(Baseline to 3 months, baseline to 6 months, baseline to 18 months)
  • Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale(Baseline to 3 months, baseline to 6 months, baseline to 18 months)

Study Sites (17)

Loading locations...

Similar Trials