Clinical trial NCT04991467: A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
Official title: A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parenting
Covid19
Keywords: COVID
Parental Stress
Social Determinants of Health
Valera
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-08-05
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 3 interventions: Care \& Valera, Care only, and Valera only.
Primary purpose: TREATMENT

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.

Detailed description: Study Design

1. 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.
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 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.

Eligibility 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.

Primary outcomes:
measure: Perceived Stress
timeFrame: week 0
measure: Perceived Stress
timeFrame: weeks 6
measure: Perceived Stress
timeFrame: week 12
measure: Perceived Stress
timeFrame: week 24
Secondary outcomes:
measure: Parental Reflective Functioning Questionnaire- Child
timeFrame: week 0
measure: Parental Reflective Functioning Questionnaire-Child
timeFrame: week 6
measure: Parental Reflective Functioning Questionnaire-Child
timeFrame: week 12
measure: Parental Reflective Functioning Questionnaire- Child
timeFrame: week 24
measure: Parent Reflective Functioning Questionnaire-Adolescent
timeFrame: week 0
measure: Parent Reflective Functioning Questionnaire-Adolescent
timeFrame: week 6
measure: Parent Reflective Functioning Questionnaire-Adolescent
timeFrame: week 12
measure: Parent Reflective Functioning Questionnaire-Adolescent
timeFrame: week 24
measure: Five Minute Speech Sample
timeFrame: week 0
measure: Five Minute Speech Sample
timeFrame: week 6
measure: Five Minute Speech Sample
timeFrame: week 12
measure: Five Minute Speech Sample
timeFrame: week 24
measure: Beck Depression Index
timeFrame: week 0
measure: Beck Depression Index
timeFrame: week 6
measure: Beck Depression Index
timeFrame: week 12
measure: Beck Depression Index
timeFrame: week 24
measure: Beck Anxiety Index
timeFrame: week 0
measure: Beck Anxiety Index
timeFrame: week 6
measure: Beck Anxiety Index
timeFrame: week 12
measure: Beck Anxiety Index
timeFrame: week 24
measure: Beck Suicide Scale Inventory
timeFrame: week 0
measure: Beck Suicide Scale Inventory
timeFrame: week 6
measure: Beck Suicide Scale Inventory
timeFrame: week 12
measure: Beck Suicide Scale Inventory
timeFrame: week 24
measure: Parent Stress Index
timeFrame: week 0
measure: Parent Stress Index
timeFrame: week 12
measure: Parent Stress Index
timeFrame: week 24
Other outcomes:
measure: Multidimensional Scale of Perceived Social Support
timeFrame: week 0
measure: Multidimensional Scale of Perceived Social Support
timeFrame: week 24
measure: Youth Outcome Questionnaire
timeFrame: week 0
measure: Youth Outcome Questionnaire
timeFrame: week 24
measure: COVID Impact Scale
timeFrame: week 0
measure: COVID Impact Scale
timeFrame: week 12
measure: COVID Impact Scale
timeFrame: week 24
measure: Kansas Parental Satisfaction Scale
timeFrame: week 0
measure: Kansas Parental Satisfaction Scale
timeFrame: week 6
measure: Kansas Parental Satisfaction Scale
timeFrame: week 12
measure: Kansas Parental Satisfaction Scale
timeFrame: week 24
measure: Family Assessment Device-General Functioning Scale
timeFrame: week 0
measure: Family Assessment Device-General Functioning Scale
timeFrame: week 12
measure: Family Assessment Device-General Functioning Scale
timeFrame: week 24
measure: Life Events Checklist
timeFrame: week 0
measure: Life Events Checklist
timeFrame: week 12
measure: Life Events Checklist
timeFrame: week 24
measure: Health Related Quality of Life
timeFrame: week 0
measure: Health Related Quality of Life
timeFrame: week 24
measure: PC-PTSD COVID
timeFrame: week 0
measure: PC-PTSD COVID
timeFrame: week 24
measure: RaLES-B
timeFrame: week 0
measure: Multidimensional assessment of emotion regulation and dysregulation
timeFrame: week 0
measure: Multidimensional assessment of emotion regulation and dysregulation
timeFrame: week 12
measure: Multidimensional assessment of emotion regulation and dysregulation
timeFrame: week 24
measure: Multidimensional Scale Of Perceived Social Support
timeFrame: week 12
measure: PROMIS EARLY CHILDHOOD
timeFrame: week 0
measure: PROMIS EARLY CHILDHOOD
timeFrame: week 24
measure: PROMIS Parent Proxy Scale
timeFrame: week 0
measure: PROMIS Parent Proxy Scale
timeFrame: week 24
measure: Philadelphia ACE
timeFrame: week 0
measure: Multidimensional Assessment of Parenting Scale (MAPS)
timeFrame: week 0
measure: Multidimensional Assessment of Parenting Scale (MAPS)
timeFrame: week 12
measure: Multidimensional Assessment of Parenting Scale (MAPS)
timeFrame: week 24
measure: Drug Abuse Screening Test
timeFrame: week 0
measure: Drug Abuse Screening Test
timeFrame: week 12
measure: Drug Abuse Screening Test
timeFrame: week 24
measure: Alcohol Use Disorders Identification Test (Audit C)
timeFrame: week 0
measure: Alcohol Use Disorders Identification Test (Audit C)
timeFrame: week 12
measure: Alcohol Use Disorders Identification Test (Audit C)
timeFrame: week 24
measure: Treatment and Health Behavior Questionnaire
timeFrame: week 0
measure: Treatment and Health Behavior Questionnaire
timeFrame: week 6
measure: Treatment and Health Behavior Questionnaire
timeFrame: week 12
measure: Treatment and Health Behavior Questionnaire
timeFrame: week 24
Locations:
city: Bronx
country: United States
facility: PRIME
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Vilma Gabbay, MD
role: PRINCIPAL_INVESTIGATOR
References: