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Mental Health in Primary Care

Primary Purpose

Depression, Anxiety, Suicide, Drug Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eHealth Familias Unidas Mental Health
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression, Anxiety focused on measuring 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

Eligibility Criteria

12 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jessie Trice Community Health CenterRecruiting
  • Broward Community HealthRecruiting
  • Community Health of South Florida
  • Prime Care HealthRecruiting
  • Care ResourceRecruiting
  • Mailman for Child DevlopmentRecruiting
  • Pediatric Mobile ClinicRecruiting
  • UM Pediatric Mobile ClinicRecruiting
  • UM UHealth Pediatrics at the Professional Arts CenterRecruiting
  • Borinquean Medical CentersRecruiting
  • Belkys Bravo ClinicRecruiting
  • Nicklaus Children HospitalRecruiting
  • South Florida Pediatric PartnersRecruiting
  • Pediatric Consultants of Kendall, P.A.Recruiting
  • UHealth Pediatrics at KendallRecruiting
  • Banyan Health SystemsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eHealth Familias Unidas

Prevention as Usual Control

Arm Description

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.

In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
June 15, 2022
Last Updated
October 17, 2023
Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT05426057
Brief Title
Mental Health in Primary Care
Official Title
Scaling a Parenting Evidence Based Intervention (EBI) for Latinx Youth Mental Health in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, sexual risk behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
eHealth Familias Unidas
Arm Type
Experimental
Arm Description
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.
Arm Title
Prevention as Usual Control
Arm Type
No Intervention
Arm Description
In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral.
Intervention Type
Behavioral
Intervention Name(s)
eHealth Familias Unidas Mental Health
Intervention Description
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 Outcome Measure Information:
Title
Depression symptoms
Description
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.
Time Frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Title
Anxiety symptoms
Description
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.
Time Frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Title
Suicidality
Description
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.
Time Frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Title
Change in drug use
Description
Change in drug use will be reported as the number of days drug use was reported over the last 90 days.
Time Frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Title
Center for Epidemiologic Studies Depression Scale (CESD)
Description
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.
Time Frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Secondary Outcome Measure Information:
Title
Change in Family Functioning as assessed by the Parenting Practices Questionnaire
Description
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.
Time Frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Title
Change in Family Functioning as assessed by the Parent Relationship with Peer Group
Description
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.
Time Frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Title
Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale
Description
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.
Time Frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months
Title
Change in unprotected sexual behavior
Description
Change in unprotected sexual behavior will be reported as number of days of sex without a condom as reported over the last 90 days.
Time Frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillermo Prado, PhD
Phone
305-284-2002
Email
gprado@miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yannine Estrada, PhD
Phone
305-284-6191
Email
yestrada@miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Prado, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
C. Hendricks Brown, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessie Trice Community Health Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joycelyn Lawrence, MD
Email
JJLawrence@jtchs.org
Facility Name
Broward Community Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noella Dietz, PhD
Facility Name
Community Health of South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33023
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Pierre
Email
Jpierre@chisouthfl.org
Facility Name
Prime Care Health
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nerelys Cantillo
Email
Ncantillo@primecarefc.net
Facility Name
Care Resource
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Smith, PhD
Email
tsmith@careresource.org
Facility Name
Mailman for Child Devlopment
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luiza Mali, PhD
Email
lvm852@med.miami.edu
Facility Name
Pediatric Mobile Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Gwynn, PhD
Facility Name
UM Pediatric Mobile Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Gwynn, MD
Email
lgwynn@med.miami.edu
Facility Name
UM UHealth Pediatrics at the Professional Arts Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lourdes Q Forster, MD
Email
lforster@med.miami.edu
Facility Name
Borinquean Medical Centers
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego Shmuels, MD
Email
dshmuels@borinquenhealth.org
Facility Name
Belkys Bravo Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora Barandiaran
Email
nora@belkysbravomd.com
Facility Name
Nicklaus Children Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Tyrkala, PhD
Email
ana.tyrkala@nicklaushealth.org
Facility Name
South Florida Pediatric Partners
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Veloz, ARNP
Email
Drtania@comcast.net
Facility Name
Pediatric Consultants of Kendall, P.A.
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dietriss Treminio
Phone
305-223-3131
Email
marvinriosoff@gmail.com
Facility Name
UHealth Pediatrics at Kendall
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Torres, PhD
Email
n.sosa@med.miami.edu
Facility Name
Banyan Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Andrews, MBA
Email
KAndrews@banyanhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

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