A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 367
- 试验地点
- 1
- 主要终点
- Change in Caregiver Perceived Stress
研究概览
简要总结
For caregivers in the Bronx, the pandemic has caused unprecedented psychological distress; in addition to combating social determinants of health (SDOH), these families now face greater financial insecurity and challenges related to their school-aged children. Furthermore, social distancing requirements and limited telehealth resources for Bronx families have posed greater barriers to healthcare. Such parental distress contributes to heightened risk of transgenerational cycles of psychological stress, trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic have had significant consequences for family well-being, putting parents at higher risk of experiencing distress and potentially impairing their ability to provide supportive care to their children. Although children may be less susceptible to the most damaging physical consequences of COVID-19, there are growing concerns regarding the short-and long-term impacts of pandemic-related stressors on children. The marked upheaval of family life over an extended period may make children vulnerable to mental health consequences associated with the public health crisis and infection mitigation efforts. School and childcare closures, unstable financial circumstances, social isolation and lack of support have a disproportionate, cumulative impact on parents and may undermine their capacities to provide support for their children. Importantly, a large body of evidence suggests that parental stress during times of disasters induces psychopathologies in family members including children. Further, high anxiety and depressive symptoms in parents during the pandemic have been associated with higher child abuse potential, whereas greater parental support was associated with lower perceived stress and child abuse potential. In addition to psychological impacts, stress associated with caregiving can interfere with parents' ability to maintain their own health. This multimodal study addresses key strategies to mitigate the psychological and health impact of COVID-19 in parents.
详细描述
Study Design
- Objectives The study team hypothesizes that both the CARE program and the Valera Health app will mitigate the psychological effects of COVID-19 while enhancing access to healthcare in the Bronx. The study will take place at Montefiore Medical Center (MMC), the largest health system in the Bronx, serving predominantly racial and ethnic minority individuals from underserved families. This study will focus on three vulnerable caregiver cohorts presenting with moderate stress: a) caregivers of children with psychiatric conditions (N=130); b) caregivers of children with autoimmune illnesses (N=130); c) caregivers who are frontline healthcare workers at MMC (N=130). While the latter may have more favorable SDOH than families treated at MMC, this cohort has faced unprecedented stress during the pandemic. A randomized controlled trial (RCT) (Stage III, NIH model) with 3 arms will test the study hypothesis: a) CARE program alone; b) Valera Health app; and c) CARE program and Valera Health app. Study procedures will include phone screen to assess eligibility, and surveys at four timepoints: (at study enrollment, 6-, 12- and 24-weeks) will assess parental stress, reflective functioning (RF), barriers to access to healthcare, mood and anxiety symptoms, suicidality (safety) and additional parent and child clinical measures. Smartphones and connectivity will be provided as needed.
Aim 1. To examine the efficacy of the 12-week CARE program on caregivers' emotional health and RF. Hyp. 1: (a) Compared to the Valera Health app arm at 12- and 24-week follow-up, participation in the CARE program will result in decreased caregiver's perceived stress, increased RF, and improved caregiver's mood and anxiety symptoms. (b) Therapeutic improvements in Hypothesis 1a will be mediated by RF, as it reflects mentalizing capacity.
Aim 2: To examine the efficacy of the 12-week Valera Health app on caregivers' emotional health and access to healthcare. Hypothesis 2: (a), The Valera Health app, will result in decreased caregiver's perceived stress, increased access to healthcare, and increased adherence to and engagement in treatment. (b) CARE program + Valera Health app arm will be superior to CARE or Valera Health app alone on all outcome measures.
Exploratory Aim: (a) The study will also explore the effects on outcome of providing technology and connectivity to families who lack them during the study period. (b) The relative effectiveness of the intervention among the 3 vulnerable cohorts will be explored. (c) Machine learning approaches to explore complex patterns as predictors of outcome including COVID-19 illness/deaths, medical comorbidity, psychopathology, housing, poverty, children's school status, age, family functioning, and trauma, will be utilized. 2. Study Timelines
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All participants will be primary caregivers who present with moderate level of stress by meeting a severity score of ≥ 14 on the Perceived Stress Scale (PSS)
- •Investigators will allow primary caregivers (e.g., grandmothers and aunts) as it is common in the patient population
- •Clinical cohorts will be active patients in the psychiatric and rheumatology clinics in Montefiore Medical Center (MMC)
- •Frontline health care providers will be those who are required to work on site at Montefiore Medical Center (MMC)
排除标准
- •Serious psychiatric or substance use difficulty that, in the judgement of the PI, would preclude meaningful participation in a parent intervention
- •Active child abuse/maltreatment cases
- •Neurocognitive conditions that may prevent participants from accessing telehealth services
- •Primary language other than Spanish or English
- •Use of the Valera Health app or a smartphone health platform similar to the Valera app
研究组 & 干预措施
Parents of children receiving mental health treatment at Montefiore
Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .
干预措施: CARE Program (Behavioral)
Parents of children being treated for autoimmune disorders at Montefiore
Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
干预措施: CARE Program (Behavioral)
Parents of children receiving mental health treatment at Montefiore
Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .
干预措施: CARE Program and Valera Application with care manager functionality (Behavioral)
Parents of children receiving mental health treatment at Montefiore
Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app .
干预措施: Valera Application with care manager functionality (Behavioral)
Parents of children being treated for autoimmune disorders at Montefiore
Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
干预措施: CARE Program and Valera Application with care manager functionality (Behavioral)
Parents of children being treated for autoimmune disorders at Montefiore
Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
干预措施: Valera Application with care manager functionality (Behavioral)
Healthcare workers at Montefiore
Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
干预措施: CARE Program (Behavioral)
Healthcare workers at Montefiore
Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
干预措施: Valera Application (Behavioral)
Healthcare workers at Montefiore
Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app.
干预措施: CARE Program and Valera Application (Behavioral)
结局指标
主要结局
Change in Caregiver Perceived Stress
时间窗: From Week 0 to Week 6, Week 12, and Week 24
Change in Caregiver Perceived Stress will be assessed using the Perceived Stress Scale (PSS). The PSS is 10-item scale which measures the degree to which situations in one's life are appraised as stressful and serves as an assessment of overall stress. Participants provide responses on the PSS based on their perceptions of stress over the prior month. Items are scored on a 5-point Likert scale ranging from 0 ("Never") to 4 ("Very Often"), for an overall possible score of 0-40. Responses to the 4 positively worded items on the scale (Items 4, 5, 7, and 8) are reverse scored (e.g., 0=4 and 4=0). Higher overall scores are associated with greater perceived stress over the past month. For purposes of this study change from baseline will be assessed and positive scores are associated with increased perceptions of stress. Scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will be used to compare parental stress vs. baseline within each arm.
次要结局
- Change in Parental Reflective Functioning (PRF) - Children(From Week 0 to Week 6, Week 12, and Week 24)
- Change in Parent Reflective Functioning (PRF) - Adolescent(From Week 0 to Week 6, Week 12, and Week 24)
- Change in Access to Healthcare(From Week 0 to Week 6, Week 12, and Week 24)
- Change in Depression(From Week 0 to Week 6, Week 12, and Week 24)
- Change in Anxiety(From Week 0 to Week 12, and Week 24)
- Change in Suicidal Ideation (Safety Measure)(From Week 0 to Week 6, Week 12 and Week 24)