Depression, Anxiety, Drug Use, Suicide
Conditions
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
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.
Interventions
BEHAVIORALeHealth 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.
Sponsors
University of Miami
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 16 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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. |
Countries
United States
Contacts
CONTACTGuillermo Prado, PhD
CONTACTYannine Estrada, PhD
PRINCIPAL_INVESTIGATORGuillermo Prado, PhD
University of Miami
PRINCIPAL_INVESTIGATORC. Hendricks Brown, PhD
Northwestern University
Outcome results
None listed