Scaling a Parenting Evidence Based Intervention (EBI) for Latinx Youth Mental Health in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 468
- 试验地点
- 33
- 主要终点
- Depression symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •Families reporting plans to move out of the South Florida area during the study period.
研究组 & 干预措施
Prevention as Usual Control
In this condition, participants will not receive an intervention, only the standard of care services which may include information and referral.
eHealth Familias Unidas
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.
干预措施: eHealth Familias Unidas Mental Health (Behavioral)
结局指标
主要结局
Depression symptoms
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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 unprotected sexual behavior(Baseline to 3 months, baseline to 6 months, baseline to 18 months)
- 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 as assessed by the Parent-Adolescent Communication Scale(Baseline to 3 months, baseline to 6 months, baseline to 18 months)
研究者
Guillermo Prado
Professor
University of Miami