Mental Health in Primary Care

August 14, 2026 updated by: Guillermo Prado, University of Miami

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
468

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33136
        • Recruiting
        • Pediatric Mobile Clinic
        • Contact:
          • Lisa Gwynn, PhD
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33136
        • Recruiting
        • UM UHealth Pediatrics at the Professional Arts Center
        • Contact:
      • Miami, Florida, United States, 33137
      • Miami, Florida, United States, 33176
      • Miami, Florida, United States, 33021
        • Withdrawn
        • Broward Community Health
      • Miami, Florida, United States, 33189
        • Withdrawn
        • Banyan Health Systems
      • Miami, Florida, United States, 33010
        • Completed
        • Jessie Trice Community Health Center
      • Miami, Florida, United States, 33023
        • Completed
        • Community Health of South Florida
      • Miami, Florida, United States, 33125
        • Completed
        • Medlife Clinical Research
      • Miami, Florida, United States, 33134
        • Completed
        • Prime Care Health
      • Miami, Florida, United States, 33135
        • Completed
        • Care Resource
      • Miami, Florida, United States, 33145
        • Completed
        • Belkys Bravo Clinic
      • Miami, Florida, United States, 33155
        • Completed
        • Nicklaus Children Hospital
      • Miami, Florida, United States, 33173
        • Completed
        • South Florida Pediatric Partners
      • Miami, Florida, United States, 33175
        • Completed
        • Pediatric Consultants of Kendall, P.A.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Female and male adolescents, who self-identify as Hispanic (or Latino(a))
  2. Adolescent between the ages of 12 - 16 years
  3. Adolescent living with an adult primary caregiver who is willing to participate
  4. 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.)
  5. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: eHealth Familias Unidas
Participants in this group will receive eHealth Familias Unidas-Mental Health. The intervention consists of nine video parent group sessions, one video adolescent session, and four family sessions (parents participate in a total of 13 sessions, adolescents participate in a total of five sessions) that will be delivered by a facilitator to the parent-child dyad via web-conferencing software across 13 weeks.
Behavioral: eHealth Familias Unidas Mental Health
eHealth Familias Unidas is a program designed to target mental health and suicide ideation and behavior. It focuses on promoting mental health by strengthening family and interpersonal protective factors. The program is provided online over a total of 13 sessions: 9 video parent group sessions, each lasting 20-40 minutes in Spanish and 4 web family sessions lasting 45 minutes in either Spanish or English, depending on participant language preference. The video parent group sessions consist of: 1) culturally syntonic telenovela/soap opera series, 2) videotaped parent group discussions, 3) interactive exercises. Web family sessions will be conducted by a trained pediatric staff member.
No Intervention: Prevention as Usual Control
In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
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.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
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.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
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.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
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.
Baseline to 3 months, baseline to 6 months, baseline to 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Family Functioning as assessed by the Parenting Practices Questionnaire
Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in family functioning will be reported using nine items from the Parenting Practices Questionnaire . Response range varies based on questions, but most response items range from 0 to 4 with higher values indicating better parenting. Scores range from 0 to 36.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in Family Functioning as assessed by the Parent Relationship with Peer Group
Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in family functioning will be reported using the Parent Relationship with Peer Group. The Parent Relationship with Peer Group is a six item measure with response items ranging from 0 to 24. Higher scores indicate better outcomes.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale
Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in family functioning will be reported using the Parent-Adolescent Communication Scale. The Parent-Adolescent Communication Scale is a twenty-item questionnaire with a total score ranging from 20 to 100 with higher scores indicating better communication.
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in unprotected sexual behavior
Time Frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in unprotected sexual behavior will be reported as number of days of sex without a condom as reported over the last 90 days.
Baseline to 3 months, baseline to 6 months, baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Guillermo Prado, PhD, University of Miami
  • Principal Investigator: C. Hendricks Brown, PhD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 26, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 15, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20210286
  • 1R01MH124718-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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