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

Covid19 Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04991467
• Other study ID #: 2020-12561
• Secondary ID: R01MH126821
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: December 2023
• Source: Albert Einstein College of Medicine
• Contact: Chloe Roske, AB
• Phone: 51668472019
• Email: chloe.roske[@]einsteinmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Parenting

Intervention

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.
• 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.
• CARE Program
Participant will take part in 12 week CARE program.
• Valera Application
Participant will receive the Valera health application which will provide parent education materials.
• 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.

Locations

Country	Name	City	State
United States	PRIME	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Multidimensional Scale of Perceived Social Support	MPSS	week 0
Other	Multidimensional Scale of Perceived Social Support	MPSS change	week 24
Other	Youth Outcome Questionnaire	YOQ	week 0
Other	Youth Outcome Questionnaire	YOQ change	week 24
Other	COVID Impact Scale	COVID Impact Scale	week 0
Other	COVID Impact Scale	COVID Impact Scale change	week 12
Other	COVID Impact Scale	COVID Impact Scale change	week 24
Other	Kansas Parental Satisfaction Scale	KPSS	week 0
Other	Kansas Parental Satisfaction Scale	KPSS change	week 6
Other	Kansas Parental Satisfaction Scale	KPSS change	week 12
Other	Kansas Parental Satisfaction Scale	KPSS change	week 24
Other	Family Assessment Device-General Functioning Scale	FAD	week 0
Other	Family Assessment Device-General Functioning Scale	FAD change	week 12
Other	Family Assessment Device-General Functioning Scale	FAD change	week 24
Other	Life Events Checklist	LEC	week 0
Other	Life Events Checklist	LEC change	week 12
Other	Life Events Checklist	LEC change	week 24
Other	Health Related Quality of Life	Caregiver Quality of Life	week 0
Other	Health Related Quality of Life	Caregiver Quality of Life change	week 24
Other	PC-PTSD COVID	PC-PTSD COVID	week 0
Other	PC-PTSD COVID	PC-PTSD COVID change	week 24
Other	RaLES-B	Discrimination	week 0
Other	Multidimensional assessment of emotion regulation and dysregulation	DERS-18	week 0
Other	Multidimensional assessment of emotion regulation and dysregulation	DERS-18 change	week 12
Other	Multidimensional assessment of emotion regulation and dysregulation	DERS-18 change	week 24
Other	Multidimensional Scale Of Perceived Social Support	MPSS change	week 12
Other	PROMIS EARLY CHILDHOOD	PROMIS EARLY CHILDHOOD	week 0
Other	PROMIS EARLY CHILDHOOD	PROMIS EARLY CHILDHOOD change	week 24
Other	PROMIS Parent Proxy Scale	PROMIS Parent Proxy Scale	week 0
Other	PROMIS Parent Proxy Scale	PROMIS Parent Proxy Scale change	week 24
Other	Philadelphia ACE	Philadelphia ACE	week 0
Other	Multidimensional Assessment of Parenting Scale (MAPS)	(MAPS)	week 0
Other	Multidimensional Assessment of Parenting Scale (MAPS)	(MAPS) change	week 12
Other	Multidimensional Assessment of Parenting Scale (MAPS)	(MAPS) change	week 24
Other	Drug Abuse Screening Test	DAST	week 0
Other	Drug Abuse Screening Test	DAST change	week 12
Other	Drug Abuse Screening Test	DAST change	week 24
Other	Alcohol Use Disorders Identification Test (Audit C)	Audit C	week 0
Other	Alcohol Use Disorders Identification Test (Audit C)	Audit C change	week 12
Other	Alcohol Use Disorders Identification Test (Audit C)	Audit C change	week 24
Other	Treatment and Health Behavior Questionnaire	Treatment and Health Behavior Questionnaire	week 0
Other	Treatment and Health Behavior Questionnaire	Treatment and Health Behavior Questionnaire	week 6
Other	Treatment and Health Behavior Questionnaire	Treatment and Health Behavior Questionnaire	week 12
Other	Treatment and Health Behavior Questionnaire	Treatment and Health Behavior Questionnaire	week 24
Primary	Perceived Stress	Perceived Stress Questionnaire	week 0
Primary	Perceived Stress	Perceived Stress Questionnaire Change	weeks 6
Primary	Perceived Stress	Perceived Stress Questionnaire Change	week 12
Primary	Perceived Stress	Perceived Stress Questionnaire Change	week 24
Secondary	Parental Reflective Functioning Questionnaire- Child	Parental Reflective Functioning Questionnaire	week 0
Secondary	Parental Reflective Functioning Questionnaire-Child	Parental Reflective Functioning Questionnaire Change	week 6
Secondary	Parental Reflective Functioning Questionnaire-Child	Parental Reflective Functioning Questionnaire Change	week 12
Secondary	Parental Reflective Functioning Questionnaire- Child	Parental Reflective Functioning Questionnaire Change	week 24
Secondary	Parent Reflective Functioning Questionnaire-Adolescent	Parental Reflective Functioning Questionnaire	week 0
Secondary	Parent Reflective Functioning Questionnaire-Adolescent	Parental Reflective Functioning Questionnaire change	week 6
Secondary	Parent Reflective Functioning Questionnaire-Adolescent	Parental Reflective Functioning Questionnaire change	week 12
Secondary	Parent Reflective Functioning Questionnaire-Adolescent	Parental Reflective Functioning Questionnaire change	week 24
Secondary	Five Minute Speech Sample	FMSS	week 0
Secondary	Five Minute Speech Sample	FMSS Change	week 6
Secondary	Five Minute Speech Sample	FMSS Change	week 12
Secondary	Five Minute Speech Sample	FMSS Change	week 24
Secondary	Beck Depression Index	BDI	week 0
Secondary	Beck Depression Index	BDI change	week 6
Secondary	Beck Depression Index	BDI change	week 12
Secondary	Beck Depression Index	BDI change	week 24
Secondary	Beck Anxiety Index	BAI Change	week 0
Secondary	Beck Anxiety Index	BAI Change	week 6
Secondary	Beck Anxiety Index	BAI Change	week 12
Secondary	Beck Anxiety Index	BAI Change	week 24
Secondary	Beck Suicide Scale Inventory	BSSI	week 0
Secondary	Beck Suicide Scale Inventory	BSSI Change	week 6
Secondary	Beck Suicide Scale Inventory	BSSI Change	week 12
Secondary	Beck Suicide Scale Inventory	BSSI Change	week 24
Secondary	Parent Stress Index	PSI-4	week 0
Secondary	Parent Stress Index	PSI-4 change	week 12
Secondary	Parent Stress Index	PSI-4 change	week 24