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NCT Number: NCT05426057

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Drug Use Mental Disorders Self-Injurious Behavior Suicide

Age range

12 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banyan Health Systems, Miami, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

eHealth Familias Unidas Mental Health

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillermo Prado, PhD

CONTACT

[email protected]

305-284-2002

Yannine Estrada, PhD

CONTACT

[email protected]

305-284-6191

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jun 21, 2022
Registry last updated
Aug 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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