Collaborative Approach to Examining Adversity and Building Resilience Study

Caregiver Stress Clinical Trial

— CARE  

Official title:

Collaborative Approach to Examining Adversity and Building Resilience Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05259436
• Other study ID #: 21-34534
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2022
• Est. completion date: April 28, 2024

Study information

• Verified date: July 2023
• Source: University of California, San Francisco
• Contact: Neeta Thakur, MD, MPH
• Phone: 628-206-8314
• Email: neeta.thakur[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care.

Description:

Early-life trauma and related adversities are prevalent and associated with negative health and achievement outcomes. These adverse childhood experiences (ACEs) are especially common in economically disadvantaged and communities of color. While there has been tremendous growth in knowledge about ACEs and their impact on health across the life course, critical gaps persist: 1) Which biologic pathways are most affected by ACEs during early childhood and may help identify those children at greatest risk for future poor health? And, 2) How may child and family resilience be bolstered across the care continuum to mitigate the negative health effects of ACEs? These critical gaps severely limit our ability to effectively identify children at high-risk and to intervene to promote resilience before poor health occurs.

Three previously piloted resilience-promoting, caregiver-child interventions will be examined: primary care-based, group-delivered Resilience Clinic (RC); home-based, dyadic Attachment and Biobehavioral Catch-up (ABC); and primary care-based, dyadic Resiliency Family Program (RFP). Using a randomized wait- list controlled trial design,12 families will be assigned to intervention or enhanced primary care (n=50/arm in each intervention, total n=300). Pre-post intervention health (behavioral, caregiver stress) and biology will be compared between intervention and controls, as well as modifying factors such as setting and delivery method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 28, 2024
• Est. primary completion date: April 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

1. Regular access to web-based computer, smart phone, or tablet if necessary to delivery via telehealth due to the COVID19 Pandemic (relative exclusion criteria - have budgeted to provide tablets and mobile wifi hot spots for up to 10% of participants)

2. Attachment and Biobehavioral Catch-up (ABC) Program

• Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking

• Child: 2 to 4 years, PEARLS score > 1

3. Resilience Clinic

• Caregiver: 18 years old and older, primary caregiver, English or Spanish speaking

• Child: 2 to 5 years, PEARLS score > 1 or verbal disclosure of PEARLS adversity to primary care clinician/staff

4. HEROES Family Program

• Caregiver: 18 years old and older, primary caregiver, ACE score > 2 if child PEARLS score = 0, English or Spanish speaking

• Child: 2 to 5 years, PEARLS score > 1

Exclusion Criteria:

1. Caregiver: active suicidality, other psychiatric issues

2. Child: significant medical co-morbidities (i.e. disease requiring immunomodulators, chemo or radiation therapy, or hormonal therapy)

Related Conditions & MeSH terms

• Caregiver Stress
• Early Life Adversity

Intervention

Behavioral:
• Caregiver-child Intervention
Intervention Groups: Resilience Clinic (Benioff Oakland): 6 weekly interactive group-based visits in primary care that draws from the evidence-based Circle of Security Parenting along with the principles of mindfulness; ABC Intervention (Lifelong): 10 weekly home visiting sessions. ABC is an empirically supported parenting program that focuses on improving maternal sensitivity; and, Resiliency Family Program (Santa Barbara Neighborhood Clinic): 4 primary-care-based visits, every 2-3 weeks, that include psycho-education materials drawing from the culturally-responsive, evidence-based program, Madres a Madres.
• Enhanced Primary Care
Enhanced Primary Care (control group): This includes care coordination services for community resources in addition to usual care. Participants will be asked about any unmet social needs, e.g. food insecurity, financial strain, safe places to play. Those who endorse need will be offered navigational services to link to community resources.

Locations

Country	Name	City	State
United States	UCSF Benioff Children's Hospital Oakland	Oakland	California
United States	LifeLong Medical Care	Richmond	California
United States	Zuckerberg San Francisco General Hospital and Trauma Center	San Francisco	California
United States	Santa Barbara Neighborhood Clinics	Santa Barbara	California

Sponsors (6)

Lead Sponsor	Collaborator
University of California, San Francisco	Futures Without Violence, Lifelong Medical Care, Santa Barbara Neighborhood Clinics, UCSF Benioff Children's Hospital Oakland, University of California, Santa Barbara

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Parenting Stress Index (PSI) score	Caregiver reported survey validated measure of parenting stress. The Parenting Stress Index - Short Form (PSI) is a 36-item self-report measure completed by parents to measure stress level within the context of parenting. Participants respond to items on a 5-point Likert scale. Responses to each item in a sub-category are totaled to calculate three subcategory scores, which are summed to represent a total parenting stress score. Higher scores indicate higher levels of parenting stress.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Primary	Change in Child Behavior Checklist (CBCL) total problems scale score	Caregiver reported survey validated measure of child behavioral and emotional challenges on the Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA). The CBCL is standardized for children ages 1.5 to 5 years. Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months. The range of possible values is 0-100.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary	Change in global health (PROMIS global health)	PROMIS® (Patient-Reported Outcomes Measurement Information System®) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. This study uses the first question on the global scale, with minimum value of 1 and maximum of 5. Higher scores mean better general health.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary	Change in caregiver depression (PHQ) total score	Caregiver reported survey validated measure of self-report depressive symptoms on the Patient Health Questionnaire (PHQ). Respondents are asked 8 questions to rate from 0 for "not at all" to 3 for "nearly every day" based on the past two weeks. The range of possible values is from 0-27. Higher scores indicate higher self-report depressive symptoms.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary	Change in caregiver anxiety (GAD) total score	Caregiver reported survey validated measure of self-report symptoms of general anxiety on the General Anxiety Disorder (GAD) questionnaire. Respondents are asked 7 questions to rate from 0 for "not at all" to 3 for "nearly every day" based on the past two weeks. The range of possible values is from 0-21. Higher score indicates higher self-report general anxiety symptoms.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary	Change in family cohesion total score	The Family Adaptability and Cohesion Evaluation Scales II (FACES II) family cohesion scale evaluates eight concepts (2 items each): emotional bonding, family boundaries, coalitions, time, space, friends, decision-making, and interest and recreation. Respondents rate from 1 for "almost never or never" to 5 for "almost always or always." A higher score indicates high family cohesion.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary	Change in adult reported social and emotional support (ARSES) total score	Adult-reported social and emotional support is assessed using a standardized single item, "How often do you get the social and emotional support you need?" Response choices were "always," "usually," "sometimes," "rarely," or "never."	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary	Change in atopy (ISSAC screen)	ISAAC was an epidemiological study following a survey of 2 million children worldwide to evaluate the prevalence of atopic disease in various ethnic backgrounds. The questionnaire is self-reported by parents and children to evaluate asthma, allergic rhinitis and eczema in childhood. 21 items, core questionnaires to assess the prevalence and severity of asthma, rhinitis and eczema in defined populations.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary	Change in general stress (Perceived Stress Scale) total score	The Perceived Stress Scale measures the extent to which an individual perceives situations in his or her life as stressful. It is a measure of global perceived stress and asks about feelings and thoughts during the last month. Respondents are asked 10 questions to rate from 0 for "never" to 4 for "very often" based on the past month. The range of possible values is from 0-40. Higher score indicates higher perceived stress.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary	Change in health-related social needs (Accountable Health Communities total score)	Questionnaire assessing impacts of current unmet health-related social needs (6 items; housing instability and problems, food insecurity, transportation needs, problems paying for utilities/bills) and number of current social needs.; Questionnaire assessing impacts of current unmet health-related social needs (6 items; housing instability and problems, food insecurity, transportation needs, problems paying for utilities/bills) and number of current social needs.; Questionnaire assessing impacts of current unmet health-related social needs (6 items; housing instability and problems, food insecurity, transportation needs, problems paying for utilities/bills) and number of current social needs.	baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Secondary	Telomere length	Telomeres are nucleoproteins that protect the ends of chromosomes. Telomere length is a biomarker of cellular aging. Chronic stress has been associated with shorter telomere length.	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	Leptin	Leptin is a hormone primarily secreted by fat cells to reduce hunger.	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	CRP	C-reactive protein is produced by the liver in response to inflammation. Higher level of CRP in the blood is an indicator of inflammation.	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	IGFBP1	Insulin-like growth factor binding protein 1 is mainly expressed in the liver and circulates in plasma where it interacts with IGF-1 and 2. IGFBP-1 plays an important role in metabolism and low levels of this protein has associated with impaired glucose tolerance and hypertension	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	HA1C	The hemoglobin A1c (glycated hemoglobin, glycosylated hemoglobin, HbA1c, or A1c) test is used to evaluate a person's level of glucose control. The test shows an average of the blood sugar level over the past 90 days and represents a percentage.	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	blood pressure	Systolic and diastolic blood pressure, averaged across 3 readings.	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	resting heart rate	Number of beats per minutes.	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	waist circumference	Measuring waist circumference in cm. Waist and hip measurements will be combined to report waist-hip ratio (WHR) as a dimensionless ratio of the circumference of the waist to that of the hips.	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	hip circumference	Measuring hip circumference in cm. Waist and hip measurements will be combined to report waist-hip ratio (WHR) as a dimensionless ratio of the circumference of the waist to that of the hips.	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	weight	Weight will be measured in kg. Weight and height will be combined to report BMI in kg/m^2	baseline/enrollment and 3-month follow-up after intervention ends
Secondary	height	Height will be measured in cm. Weight and height will be combined to report BMI in kg/m^2	baseline/enrollment and 3-month follow-up after intervention ends