跳至主要内容
临床试验/NCT05676281
NCT05676281已完成不适用

Healing Experiences of Adversity Among Latinos (HEALthy4You)

University of California, San Diego4 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年12月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
4
主要终点
Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months)

研究概览

简要总结

Healing Experiences of Adversity Among Latinos (HEALthy4You) is a project funded by the California Initiative for the Advancement of Precision Medicine ("Advancing a Precision Population Health Approach to ACEs to Reduce Health Disparities"). The long-term goal of this project is to develop community-centered, culturally Appropriate, precision Interventions that can be delivered within Federally Qualified Healthcare Centers (FQHCs) for Latino Families, to reduce Adverse Child Events (ACES) risks and treat childhood obesity. UCSD in conjunction with Family Health Centers of San Diego (FHCSD) will conduct a 2x2 factorial trial with four groups meant to determine what combination of intervention components influence family protective factors (a key marker for reduced risk of the deleterious effects of systemic and family/individual stressors that are a critical part of ACEs) and childhood obesity.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Currently a patient at Family Health Centers of San Diego
  • Age 5-11 years old
  • BMI ≥ 85th percentile to 99.9th percentile
  • Social determination or risk for ACE determined as being a patient receiving care at an FQHC (confirmed via provider)
  • Parent or guardian (including non-biological parent or relative) willing to participate
  • Self-identification as Hispanic or Latino
  • 18 years or older
  • English or Spanish speaking
  • Willingness to commit to 6 months of the program

排除标准

  • Serious Developmental Disability (parent or child)
  • Serious Mental Health Illness (parent or child)

研究组 & 干预措施

Healthy Together (includes Streetwyze) (Control/Standardized Care)

Other

Control - standardized Healthy Together program: The Healthy Together Program is not standard of care at Family Health Centers (FHC). Instead, it was originally developed by FHC clinicians interested in addressing childhood obesity and has been implemented by a limited number of clinicians at FHC. UCSD has been working in partnership with FHC to create standardized protocols and to incorporate additional research-oriented tools into this standardized protocol, which will be used as our experimental control.

干预措施: Healthy Together (Control) (Behavioral)

Healthy Together + Promotora support

Active Comparator

In addition to the basic program described above, those randomized to this intervention will receive Promotora support. Families assigned to a promotora will receive 30-60 minutes of phone-based support weekly, with more frequent interactions that will taper starting at month 3 of the intervention. Promotoras may also provide home-visit support up to 4 times during the 6 months, based on family interest and needs. The wellness coach will try to minimize in-person meetings with FHC professionals each week and space out visits to reduce burden on families. For families in this condition, they will be asked to engage in at least 30 minutes of additional sessions per week with the promotora beyond the 1- hour allotted time working with FHC professionals.

干预措施: Healthy Together + Promotora Support (Behavioral)

Healthy Together + Parenting training

Active Comparator

In addition to the basic program described above, those randomized to this intervention will attend Parenting Training sessions with the mental health provider at FHC. Families assigned to parenting training will receive 10-12 sessions. Sessions will focus on topics like strategies to support the child's physical, social, and emotional growth. The wellness coach will try to minimize in-person meetings with FHC professionals each week and space out visits to reduce burden on families.

干预措施: Healthy Together + Parenting Training (Behavioral)

Healthy Togethers + Parenting Training + Promotora support

Active Comparator

Those randomized to this intervention will receive all components described above including the Healthy Together Program, Parenting Training and Promotora support. The wellness coach will try to minimize in-person meetings with FHC professionals each week and space out visits to reduce burden on families.. Families in this group will also be asked to engage in at least 30-60 minutes of additional sessions per week including up to 4 home visits.

干预措施: Healthy Togethers + Parenting Training + Promotora support (Behavioral)

结局指标

主要结局

Changes in Parents' Assessment of Protective Factors Self-Report Scale (comparison baseline to 6-months)

时间窗: 6 months

Parents' Assessment of Protective Factors (PAPF) Instrument consists of 36 items to measure the presence, strength, and growth of parents' self-reported beliefs, feelings, and behaviors that are regarded as indicators of the Strengthening Families protective factors using a 5-point response system from "Not at all like me" to "Very much like me" (Score scale: 0 Low - 3.99 High)

次要结局

  • Changes to Child Body Mass Index (BMI) from baseline to 6 months(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Hekler

Professor

University of California, San Diego

研究点 (4)

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