CARE: A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 . |
Behavioral: CARE Program and Valera Application with care manager functionality
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.
Behavioral: Valera Application with care manager functionality
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.
Behavioral: CARE Program
Participant will take part in 12 week CARE program.
|
| Experimental: 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. |
Behavioral: CARE Program and Valera Application with care manager functionality
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.
Behavioral: Valera Application with care manager functionality
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.
Behavioral: CARE Program
Participant will take part in 12 week CARE program.
|
| Experimental: Healthcare workers at Montefiore Participants will either CARE program alone; b) Valera Health app; c) CARE program and Valera Health app. |
Behavioral: CARE Program
Participant will take part in 12 week CARE program.
Behavioral: Valera Application
Participant will receive the Valera health application which will provide parent education materials.
Behavioral: CARE Program and Valera Application
Participant will take part in 12 week CARE program and receive the Valera health application which will provide parent education materials.
|
Outcome Measures
Primary Outcome Measures
- Perceived Stress [week 0]
Perceived Stress Questionnaire
- Perceived Stress [weeks 6]
Perceived Stress Questionnaire Change
- Perceived Stress [week 12]
Perceived Stress Questionnaire Change
- Perceived Stress [week 24]
Perceived Stress Questionnaire Change
Secondary Outcome Measures
- Parental Reflective Functioning Questionnaire- Child [week 0]
Parental Reflective Functioning Questionnaire
- Parental Reflective Functioning Questionnaire-Child [week 6]
Parental Reflective Functioning Questionnaire Change
- Parental Reflective Functioning Questionnaire-Child [week 12]
Parental Reflective Functioning Questionnaire Change
- Parental Reflective Functioning Questionnaire- Child [week 24]
Parental Reflective Functioning Questionnaire Change
- Parent Reflective Functioning Questionnaire-Adolescent [week 0]
Parental Reflective Functioning Questionnaire
- Parent Reflective Functioning Questionnaire-Adolescent [week 6]
Parental Reflective Functioning Questionnaire change
- Parent Reflective Functioning Questionnaire-Adolescent [week 12]
Parental Reflective Functioning Questionnaire change
- Parent Reflective Functioning Questionnaire-Adolescent [week 24]
Parental Reflective Functioning Questionnaire change
- Five Minute Speech Sample [week 0]
FMSS
- Five Minute Speech Sample [week 6]
FMSS Change
- Five Minute Speech Sample [week 12]
FMSS Change
- Five Minute Speech Sample [week 24]
FMSS Change
- Beck Depression Index [week 0]
BDI
- Beck Depression Index [week 6]
BDI change
- Beck Depression Index [week 12]
BDI change
- Beck Depression Index [week 24]
BDI change
- Beck Anxiety Index [week 0]
BAI Change
- Beck Anxiety Index [week 6]
BAI Change
- Beck Anxiety Index [week 12]
BAI Change
- Beck Anxiety Index [week 24]
BAI Change
- Beck Suicide Scale Inventory [week 0]
BSSI
- Beck Suicide Scale Inventory [week 6]
BSSI Change
- Beck Suicide Scale Inventory [week 12]
BSSI Change
- Beck Suicide Scale Inventory [week 24]
BSSI Change
- Parent Stress Index [week 0]
PSI-4
- Parent Stress Index [week 12]
PSI-4 change
- Parent Stress Index [week 24]
PSI-4 change
Other Outcome Measures
- Multidimensional Scale of Perceived Social Support [week 0]
MPSS
- Multidimensional Scale of Perceived Social Support [week 24]
MPSS change
- Youth Outcome Questionnaire [week 0]
YOQ
- Youth Outcome Questionnaire [week 24]
YOQ change
- COVID Impact Scale [week 0]
COVID Impact Scale
- COVID Impact Scale [week 12]
COVID Impact Scale change
- COVID Impact Scale [week 24]
COVID Impact Scale change
- Kansas Parental Satisfaction Scale [week 0]
KPSS
- Kansas Parental Satisfaction Scale [week 6]
KPSS change
- Kansas Parental Satisfaction Scale [week 12]
KPSS change
- Kansas Parental Satisfaction Scale [week 24]
KPSS change
- Family Assessment Device-General Functioning Scale [week 0]
FAD
- Family Assessment Device-General Functioning Scale [week 12]
FAD change
- Family Assessment Device-General Functioning Scale [week 24]
FAD change
- Life Events Checklist [week 0]
LEC
- Life Events Checklist [week 12]
LEC change
- Life Events Checklist [week 24]
LEC change
- Health Related Quality of Life [week 0]
Caregiver Quality of Life
- Health Related Quality of Life [week 24]
Caregiver Quality of Life change
- PC-PTSD COVID [week 0]
PC-PTSD COVID
- PC-PTSD COVID [week 24]
PC-PTSD COVID change
- RaLES-B [week 0]
Discrimination
- Multidimensional assessment of emotion regulation and dysregulation [week 0]
DERS-18
- Multidimensional assessment of emotion regulation and dysregulation [week 12]
DERS-18 change
- Multidimensional assessment of emotion regulation and dysregulation [week 24]
DERS-18 change
- Multidimensional Scale Of Perceived Social Support [week 12]
MPSS change
- PROMIS EARLY CHILDHOOD [week 0]
PROMIS EARLY CHILDHOOD
- PROMIS EARLY CHILDHOOD [week 24]
PROMIS EARLY CHILDHOOD change
- PROMIS Parent Proxy Scale [week 0]
PROMIS Parent Proxy Scale
- PROMIS Parent Proxy Scale [week 24]
PROMIS Parent Proxy Scale change
- Philadelphia ACE [week 0]
Philadelphia ACE
- Multidimensional Assessment of Parenting Scale (MAPS) [week 0]
(MAPS)
- Multidimensional Assessment of Parenting Scale (MAPS) [week 12]
(MAPS) change
- Multidimensional Assessment of Parenting Scale (MAPS) [week 24]
(MAPS) change
- Drug Abuse Screening Test [week 0]
DAST
- Drug Abuse Screening Test [week 12]
DAST change
- Drug Abuse Screening Test [week 24]
DAST change
- Alcohol Use Disorders Identification Test (Audit C) [week 0]
Audit C
- Alcohol Use Disorders Identification Test (Audit C) [week 12]
Audit C change
- Alcohol Use Disorders Identification Test (Audit C) [week 24]
Audit C change
- Treatment and Health Behavior Questionnaire [week 0]
Treatment and Health Behavior Questionnaire
- Treatment and Health Behavior Questionnaire [week 6]
Treatment and Health Behavior Questionnaire
- Treatment and Health Behavior Questionnaire [week 12]
Treatment and Health Behavior Questionnaire
- Treatment and Health Behavior Questionnaire [week 24]
Treatment and Health Behavior Questionnaire
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PRIME | Bronx | New York | United States | 10461 |
Sponsors and Collaborators
- Albert Einstein College of Medicine
- National Institute of Mental Health (NIMH)
Investigators
- Principal Investigator: Vilma Gabbay, MD, Albert Einstein College of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-12561
- R01MH126821