Mental Health in Primary Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Depression, Anxiety, Suicide, Drug Use

Intervention / Treatment
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* Behavioral: eHealth Familias Unidas Mental Health


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: eHealth Familias Unidas<br>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. | Behavioral: eHealth Familias Unidas Mental Health<br>* 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.<br>|
| No Intervention: Prevention as Usual Control<br>In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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effectiveness-implementation type 1 hybrid trial, Latinx adolescent, eHealth intervention, Familias Unidas, intervention sustainment, parent-centered, family functioning, sexual risk behavior, Latinx mental health in primary care