Clinical trial NCT05426057: 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
Overall status: RECRUITING
Phase: NA
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
sexual risk behavior
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-06-21
Enrollment: 468
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Depression symptoms
timeFrame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
measure: Anxiety symptoms
timeFrame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
measure: Suicidality
timeFrame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
measure: Change in drug use
timeFrame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
measure: Center for Epidemiologic Studies Depression Scale (CESD)
timeFrame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Secondary outcomes:
measure: Change in Family Functioning as assessed by the Parenting Practices Questionnaire
timeFrame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
measure: Change in Family Functioning as assessed by the Parent Relationship with Peer Group
timeFrame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
measure: Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale
timeFrame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
measure: Change in unprotected sexual behavior
timeFrame: Baseline to 3 months, baseline to 6 months, baseline to 18 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jessie Trice Community Health Center
state: Florida
city: Miami
country: United States
facility: Broward Community Health
state: Florida
city: Miami
country: United States
facility: Community Health of South Florida
state: Florida
city: Miami
country: United States
facility: Medlife Clinical Research
state: Florida
city: Miami
country: United States
facility: Prime Care Health
state: Florida
city: Miami
country: United States
facility: Care Resource
state: Florida
city: Miami
country: United States
facility: Mailman for Child Devlopment
state: Florida
city: Miami
country: United States
facility: Pediatric Mobile Clinic
state: Florida
city: Miami
country: United States
facility: UM Pediatric Mobile Clinic
state: Florida
city: Miami
country: United States
facility: UM UHealth Pediatrics at the Professional Arts Center
state: Florida
city: Miami
country: United States
facility: Borinquean Medical Centers
state: Florida
city: Miami
country: United States
facility: Belkys Bravo Clinic
state: Florida
city: Miami
country: United States
facility: Nicklaus Children Hospital
state: Florida
city: Miami
country: United States
facility: South Florida Pediatric Partners
state: Florida
city: Miami
country: United States
facility: Pediatric Consultants of Kendall, P.A.
state: Florida
city: Miami
country: United States
facility: UHealth Pediatrics at Kendall
state: Florida
city: Miami
country: United States
facility: Banyan Health Systems
state: Florida
Study officials:
affiliation: University of Miami
name: Guillermo Prado, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: C. Hendricks Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: