Mental Health in Primary Care
- Conditions
- SuicideDepression, AnxietyDrug Use
- Interventions
- Behavioral: eHealth Familias Unidas Mental Health
- Registration Number
- NCT05426057
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 468
- 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).
- Families reporting plans to move out of the South Florida area during the study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description eHealth Familias Unidas eHealth Familias Unidas Mental Health 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.
- Primary Outcome Measures
Name Time Method Depression symptoms 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.
Center for Epidemiologic Studies Depression Scale (CESD) 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.
Anxiety symptoms 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 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 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.
- Secondary Outcome Measures
Name Time Method Change in Family Functioning as assessed by the Parent Relationship with Peer Group 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.
Change in unprotected sexual behavior 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.
Change in Family Functioning as assessed by the Parenting Practices Questionnaire 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.
Change in Family Functioning as assessed by the Parent-Adolescent Communication Scale 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.
Trial Locations
- Locations (17)
Jessie Trice Community Health Center
🇺🇸Miami, Florida, United States
Medlife Clinical Research
🇺🇸Miami, Florida, United States
Pediatric Mobile Clinic
🇺🇸Miami, Florida, United States
UM Pediatric Mobile Clinic
🇺🇸Miami, Florida, United States
UM UHealth Pediatrics at the Professional Arts Center
🇺🇸Miami, Florida, United States
Broward Community Health
🇺🇸Miami, Florida, United States
Community Health of South Florida
🇺🇸Miami, Florida, United States
Prime Care Health
🇺🇸Miami, Florida, United States
Care Resource
🇺🇸Miami, Florida, United States
Mailman for Child Devlopment
🇺🇸Miami, Florida, United States
Borinquean Medical Centers
🇺🇸Miami, Florida, United States
Belkys Bravo Clinic
🇺🇸Miami, Florida, United States
Nicklaus Children Hospital
🇺🇸Miami, Florida, United States
South Florida Pediatric Partners
🇺🇸Miami, Florida, United States
Pediatric Consultants of Kendall, P.A.
🇺🇸Miami, Florida, United States
UHealth Pediatrics at Kendall
🇺🇸Miami, Florida, United States
Banyan Health Systems
🇺🇸Miami, Florida, United States