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

Description

Study Design

1. 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

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 being 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.