Mental Health in Primary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-16
SponsorUniversity of Miami
About this trial
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
This trial accepts healthy volunteersQualifiers
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.)
Disqualifiers
Families reporting plans to move out of the South Florida area during the study period.
Trial design
Design model
Parallel
Treatments tested in this trial
eHealth Familias Unidas Mental Health
BehavioraleHealth 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.
Treatment groups
468 Participants
are divided into 2 treatment groupsGroup A: eHealth Familias UnidasExperimental treatment 1 intervention
Group B: Prevention as Usual ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months2
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.
Time frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months3
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.
Time frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months4
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.
Time frame
Baseline to 3 months, baseline to 6 months, baseline to 18 monthsSecondary outcomes
1
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.
Time frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months2
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.
Time frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months3
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.
Time frame
Baseline to 3 months, baseline to 6 months, baseline to 18 months4
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.
Time frame
Baseline to 3 months, baseline to 6 months, baseline to 18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Miami
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov