A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx

Study Overview
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Brief Summary
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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.

Detailed Description
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Study Design Objectives We hypothesize 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. We 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 RCT (Stage III, NIH model) with 3 arms will test our hypothesis: a) CARE program alone; b) Valera Health app; c) CARE program and Valera Health app; Study procedures will include four surveys: at study enrollment, 6-, 12- and 24-weeks and will assess parental stress (primary outcome), reflective functioning (RF), access to healthcare, mood and anxiety 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 Hyp. 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. Hyp. 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) We will also explore the effects on outcome of providing technology and connectivity to families who lack them during the study period. (b) We will explore the relative effectiveness of our intervention among the 3 vulnerable cohorts. (c) We will also utilize 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. Study Timelines Individual Subject Timeline: Participation in this research will last about 24 weeks. Participants will partake in 12 one hour group sessions that meet once per week. Participants will complete several surveys when enrolled in the study and then after 6 weeks, after 12 weeks, and after 24 weeks. Overall Timeline: Because Investigators intend to rely on a pre-existing clinical infrastructure, Investigators anticipate to be able to begin enrollment within the first six months of the study. Participants will return for 6-month follow-ups. Data analysis will occur throughout the duration of the study, along with publications and conference presentations. The likelihood that this study will be carried out as planned is very high, as all methods and collaborations are already in place.

Official Title
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A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx

Conditions
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Parenting, Covid19

Intervention / Treatment
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* Behavioral: CARE Program and Valera Application with care manager functionality
* Behavioral: Valera Application with care manager functionality
* Behavioral: CARE Program
* Behavioral: Valera Application
* Behavioral: CARE Program and Valera Application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 (PSS22). Investigators will allow primary caregivers (e.g., grandmothers and aunts) as it is common in our 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). Exclusion Criteria: 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. Utilized a smartphone health platform similar to the Valera app.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: 3 interventions: Care & Valera, Care only, and Valera only.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parents of children receiving mental health treatment at Montefiore<br>Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app . | Behavioral: CARE Program and Valera Application with care manager functionality<br>* Participant will take part in 12 week CARE program and receive the Valera health application which will provide parent education materials as well as the ability to connect to their child's treatment team via care manager.<br>Behavioral: Valera Application with care manager functionality<br>* Participant will receive the Valera health application which will provide parent education materials and the ability to connect to their child's treatment team via care manger.<br>Behavioral: CARE Program<br>* Participant will take part in 12 week CARE program.<br>|
| Experimental: Parents of children being treated for autoimmune disorders at Montefiore<br>Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app. | Behavioral: CARE Program and Valera Application with care manager functionality<br>* Participant will take part in 12 week CARE program and receive the Valera health application which will provide parent education materials as well as the ability to connect to their child's treatment team via care manager.<br>Behavioral: Valera Application with care manager functionality<br>* Participant will receive the Valera health application which will provide parent education materials and the ability to connect to their child's treatment team via care manger.<br>Behavioral: CARE Program<br>* Participant will take part in 12 week CARE program.<br>|
| Experimental: Healthcare workers at Montefiore<br>Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app. | Behavioral: CARE Program<br>* Participant will take part in 12 week CARE program.<br>Behavioral: Valera Application<br>* Participant will receive the Valera health application which will provide parent education materials.<br>Behavioral: CARE Program and Valera Application<br>* Participant will take part in 12 week CARE program and receive the Valera health application which will provide parent education materials.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Stress | Perceived Stress Questionnaire | week 0 | 
| Perceived Stress | Perceived Stress Questionnaire Change | weeks 6 | 
| Perceived Stress | Perceived Stress Questionnaire Change | week 12 | 
| Perceived Stress | Perceived Stress Questionnaire Change | week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Reflective Functioning Questionnaire- Child | Parental Reflective Functioning Questionnaire | week 0 | 
| Parental Reflective Functioning Questionnaire-Child | Parental Reflective Functioning Questionnaire Change | week 6 | 
| Parental Reflective Functioning Questionnaire-Child | Parental Reflective Functioning Questionnaire Change | week 12 | 
| Parental Reflective Functioning Questionnaire- Child | Parental Reflective Functioning Questionnaire Change | week 24 | 
| Parent Reflective Functioning Questionnaire-Adolescent | Parental Reflective Functioning Questionnaire | week 0 | 
| Parent Reflective Functioning Questionnaire-Adolescent | Parental Reflective Functioning Questionnaire change | week 6 | 
| Parent Reflective Functioning Questionnaire-Adolescent | Parental Reflective Functioning Questionnaire change | week 12 | 
| Parent Reflective Functioning Questionnaire-Adolescent | Parental Reflective Functioning Questionnaire change | week 24 | 
| Five Minute Speech Sample | FMSS | week 0 | 
| Five Minute Speech Sample | FMSS Change | week 6 | 
| Five Minute Speech Sample | FMSS Change | week 12 | 
| Five Minute Speech Sample | FMSS Change | week 24 | 
| Beck Depression Index | BDI | week 0 | 
| Beck Depression Index | BDI change | week 6 | 
| Beck Depression Index | BDI change | week 12 | 
| Beck Depression Index | BDI change | week 24 | 
| Beck Anxiety Index | BAI Change | week 0 | 
| Beck Anxiety Index | BAI Change | week 6 | 
| Beck Anxiety Index | BAI Change | week 12 | 
| Beck Anxiety Index | BAI Change | week 24 | 
| Beck Suicide Scale Inventory | BSSI | week 0 | 
| Beck Suicide Scale Inventory | BSSI Change | week 6 | 
| Beck Suicide Scale Inventory | BSSI Change | week 12 | 
| Beck Suicide Scale Inventory | BSSI Change | week 24 | 
| Parent Stress Index | PSI-4 | week 0 | 
| Parent Stress Index | PSI-4 change | week 12 | 
| Parent Stress Index | PSI-4 change | week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID, Parental Stress, Social Determinants of Health, Valera