Depression, AnxietyNCT05426057
Mental Health in Primary Care
A study testing eHealth Familias Unidas Mental Health in people with Depression, Anxiety and Suicide, run by University of Miami at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Suicide, Drug Use
- What is being tested?
- eHealth Familias Unidas Mental Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 468 participants
- Where
- 17 sitesUnited States
- Study dates
- 26 Apr 2022to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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).
Who cannot join
- Families reporting plans to move out of the South Florida area during the study period.
Trial locations and contacts
17 sites in 1 country. Contact the study team or a site near you to ask about taking part.
17 sites in 1 country
United States17 sites, 6 recruiting
- Completed
Jessie Trice Community Health Center
Miami, Florida, 33010
- Withdrawn
Broward Community Health
Miami, Florida, 33021
- Completed
Community Health of South Florida
Miami, Florida, 33023
- Completed
Medlife Clinical Research
Miami, Florida, 33125
- Completed
Prime Care Health
Miami, Florida, 33134
- Completed
Care Resource
Miami, Florida, 33135
- Recruiting
Mailman for Child Devlopment
Miami, Florida, 33136
Luiza Mali, PhD, lvm852@med.miami.edu
- Recruiting
Pediatric Mobile Clinic
Miami, Florida, 33136
Lisa Gwynn, PhD
- Recruiting
UM Pediatric Mobile Clinic
Miami, Florida, 33136
Lisa Gwynn, MD, lgwynn@med.miami.edu
- Recruiting
UM UHealth Pediatrics at the Professional Arts Center
Miami, Florida, 33136
Lourdes Q Forster, MD, lforster@med.miami.edu
- Recruiting
Borinquean Medical Centers
Miami, Florida, 33137
Diego Shmuels, MD, dshmuels@borinquenhealth.org
- Completed
Belkys Bravo Clinic
Miami, Florida, 33145
- Completed
Nicklaus Children Hospital
Miami, Florida, 33155
- Completed
South Florida Pediatric Partners
Miami, Florida, 33173
- Completed
Pediatric Consultants of Kendall, P.A.
Miami, Florida, 33175
- Recruiting
UHealth Pediatrics at Kendall
Miami, Florida, 33176
Nicole Torres, PhD, n.sosa@med.miami.edu
- Withdrawn
Banyan Health Systems
Miami, Florida, 33189
About this study
Official title: 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.
- Conditions
- Depression, Anxiety, Suicide, Drug Use
- Being tested
- eHealth Familias Unidas Mental Health
- Keywords
- effectiveness-implementation type 1 hybrid trial, Latinx mental health in primary care, Latinx adolescent, eHealth intervention, Familias Unidas, intervention sustainment, parent-centered, family functioning, sexual risk behavior
- Medical subject headings
- Depression, Anxiety Disorders, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealth Familias Unidas Mental HealthBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| eHealth Familias Unidas | Experimental | 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. Receives: Behavioral: eHealth Familias Unidas Mental Health |
| Prevention as Usual Control | No intervention | In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms
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.
Measured: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Anxiety symptoms
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.
Measured: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Suicidality
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.
Measured: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in drug use
Change in drug use will be reported as the number of days drug use was reported over the last 90 days.
Measured: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Center for Epidemiologic Studies Depression Scale (CESD)
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.
Measured: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Secondary outcomes (4)
Change in Family Functioning as assessed by the Parenting Practices Questionnaire
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.
Measured: 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
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.
Measured: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale
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.
Measured: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Change in unprotected sexual behavior
Change in unprotected sexual behavior will be reported as number of days of sex without a condom as reported over the last 90 days.
Measured: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start26 Apr 2022
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Guillermo Prado, University of Miami
- Investigators
- Guillermo Prado, PhD, Principal investigator, University of MiamiC. Hendricks Brown, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426057
- Sponsor's protocol ID
- 20210286
- Other IDs
- 1R01MH124718-01A1
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2022
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Estrada Y, Lozano A, Boga D, Tapia MI, Perrino T, Velazquez MR, Forster L, Torres N, Morales CV, Gwynn L, Beardslee WR, Brown CH, Prado G. eHealth Familias Unidas Mental Health: Protocol for an effectiveness-implementation hybrid Type 1 trial to scale a mental health preventive intervention for Hispanic youth in primary care settings. PLoS One. 2023 Apr 18;18(4):e0283987. doi: 10.1371/journal.pone.0283987. eCollection 2023.
PubMed 37071612
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling a Parenting Evidence Based Intervention (EBI) for Latinx Youth Mental Health in Primary Care
- ClinicalTrials.gov ID
- NCT05426057
- Acronym / sponsor ID
- 20210286
- Conditions
- Depression, Anxiety, Suicide, Drug Use
- Keywords
- effectiveness-implementation type 1 hybrid trial, Latinx mental health in primary care, Latinx adolescent, eHealth intervention, Familias Unidas, intervention sustainment, parent-centered, family functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eHealth Familias Unidas | Experimental | Behavioral: eHealth Familias Unidas Mental HealthParticipants 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. |
| Prevention as Usual Control | No intervention | –In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- Families reporting plans to move out of the South Florida area during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealth Familias Unidas Mental HealtheHealth 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. | Behavioural | eHealth Familias Unidas |
Primary outcome
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.
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.
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.
4 secondary outcomes
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 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 as assessed by the Parent-Adolescent Communication Scale
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 37071612Estrada Y, Lozano A, Boga D, Tapia MI, Perrino T, Velazquez MR, Forster L, Torres N, Morales CV, Gwynn L, Beardslee WR, Brown CH, Prado G. eHealth Familias Unidas Mental Health: Protocol for an effectiveness-implementation hybrid Type 1 trial to scale a mental health preventive intervention for Hispanic youth in primary care settings. PLoS One. 2023 Apr 18;18(4):e0283987. doi: 10.1371/journal.pone.0283987. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo Prado, PhD principal investigator
University of Miami
C. Hendricks Brown, PhD principal investigator
Northwestern University
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth Familias Unidas Mental Health in people with Depression, Anxiety and Suicide, run by University of Miami at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Prado, PhD (305-284-2002, gprado@miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptoms (time frame: Baseline to 3 months, baseline to 6 months, baseline to 18 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05426057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.