Mental Health in Primary Care

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05426057
• Other study ID #: 20210286
• Secondary ID: 1R01MH124718-01A
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: October 2023
• Source: University of Miami
• Contact: Guillermo Prado, PhD
• Phone: 305-284-2002
• Email: gprado[@]miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The study will use a randomized rollout design with 18 pediatric primary care clinics in the South Florida area.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 468
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression, Anxiety
• Drug Use
• Suicide

Intervention

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.

Locations

Country	Name	City	State
United States	Banyan Health Systems	Miami	Florida
United States	Belkys Bravo Clinic	Miami	Florida
United States	Borinquean Medical Centers	Miami	Florida
United States	Broward Community Health	Miami	Florida
United States	Care Resource	Miami	Florida
United States	Community Health of South Florida	Miami	Florida
United States	Jessie Trice Community Health Center	Miami	Florida
United States	Mailman for Child Devlopment	Miami	Florida
United States	Nicklaus Children Hospital	Miami	Florida
United States	Pediatric Consultants of Kendall, P.A.	Miami	Florida
United States	Pediatric Mobile Clinic	Miami	Florida
United States	Prime Care Health	Miami	Florida
United States	South Florida Pediatric Partners	Miami	Florida
United States	UHealth Pediatrics at Kendall	Miami	Florida
United States	UM Pediatric Mobile Clinic	Miami	Florida
United States	UM UHealth Pediatrics at the Professional Arts Center	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Primary	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.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Primary	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.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Primary	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.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Primary	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.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Secondary	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.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Secondary	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.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Secondary	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.	Baseline to 3 months, baseline to 6 months, baseline to 18 months
Secondary	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.	Baseline to 3 months, baseline to 6 months, baseline to 18 months