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Resilience-Building Interventions for Early Life Adversity (CARE Trial)
N/A
Recruiting
Led By Neeta Thakur, MD, MPH
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Resilience Clinic: Caregiver must be 18 years old and older, primary caregiver, English or Spanish speaking. Child must be 2 to 5 years with PEARLS score > 1 or verbal disclosure of PEARLS adversity to primary care clinician/staff
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Awards & highlights
CARE Trial Summary
This trial will look at how well interventions designed to promote resilience work in primary care settings.
Who is the study for?
This study is for caregivers over 18 and children aged 2-5 who have faced early life adversity. Caregivers must be the primary caregiver, speak English or Spanish, and have regular internet access. Children with significant medical conditions or caregivers with active suicidality are excluded.Check my eligibility
What is being tested?
The trial tests resilience-promoting interventions in a primary care setting. It includes Enhanced Primary Care and a special program for caregiver-child interaction to improve behavioral, psychosocial, and biological outcomes related to resilience.See study design
What are the potential side effects?
Since this trial focuses on non-medical interventions like enhanced care and psychological support programs, traditional side effects associated with medications are not expected. However, participants may experience emotional discomfort.
CARE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am the main caregiver, over 18, and speak English or Spanish. My child is aged 2-5 with a PEARLS score over 1.
CARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline/enrollment and 2 week and 3-month follow-up after intervention ends
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Child Behavior Checklist (CBCL) total problems scale score
Change in Parenting Stress Index (PSI) score
Secondary outcome measures
CRP
Change in adult reported social and emotional support (ARSES) total score
Change in atopy (ISSAC screen)
+16 moreCARE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Caregiver-Child InterventionExperimental Treatment1 Intervention
Investigators will examine the immediate psychosocial, behavioral, and child biologic response to three caregiver-child interventions depending on site of enrollment. Each interventions contain overlapping core elements, but also contribute unique facets, allowing us to examine overall intervention effects, as well as unique settings (e.g. home vs. clinic) and delivery effects (1:1 vs. group), providing insight for future direction.
Group II: Enhanced Primary CareActive Control1 Intervention
Navigational services for social need resources.
Find a Location
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,505 Previous Clinical Trials
15,237,255 Total Patients Enrolled
1 Trials studying Early Life Adversity
200 Patients Enrolled for Early Life Adversity
Lifelong Medical CareUNKNOWN
2 Previous Clinical Trials
430 Total Patients Enrolled
UCSF Benioff Children's Hospital OaklandOTHER
78 Previous Clinical Trials
24,225 Total Patients Enrolled
1 Trials studying Early Life Adversity
200 Patients Enrolled for Early Life Adversity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My child is between 2 to 5 years old with a PEARLS score above 1.My child is aged 2-4 and has a PEARLS score above 1.My caregiver does not have active suicidal thoughts or psychiatric issues.I am the main caregiver, over 18, speak English or Spanish, and my child is aged 2-5 with specific health needs.My child has a serious health condition needing strong medication or therapy.I am over 18, the main caregiver, and speak English or Spanish. My child is aged 2-4 with a PEARLS score over 1.I am the main caregiver, over 18, and speak English or Spanish. My child is aged 2-5 with a PEARLS score over 1.I am enrolled in the ABC Program.
Research Study Groups:
This trial has the following groups:- Group 1: Caregiver-Child Intervention
- Group 2: Enhanced Primary Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment open for participation in this experiment?
"The evidence on clinicialtrials.gov suggests that this trial is actively recruiting patients since its initial posting on April 11th, 2022 and most recent update occurring a few weeks later."
Answered by AI
How many participants is this research endeavor recruiting?
"Affirmative. On clinicaltrials.gov, one can discover that this medical trial is recruiting patients; it was published on April 11th 2022 and edited most recently on the 25th of the same month. This study requires 300 people to partake across 4 locations."
Answered by AI
How many research centers are involved in the investigation of this trial?
"For this clinical trial, medical centres such as LifeLong Medical Care in Richmond, Zuckerberg San Francisco General Hospital and Trauma Center in San Francisco, and Santa Barbara Neighborhood Clinics have been enlisted to participate. These are just a few of the 4 operating sites for this study."
Answered by AI
What are the anticipated outcomes of this experiment?
"The primary metric for this clinical trial is the Child Behavior Checklist (CBCL) total problems scale score, which will be monitored at baseline/enrollment and two-week and three-month follow-up intervals after intervention. Other secondary outcomes include blood pressure averages from three readings, change in caregiver anxiety as measured by the General Anxiety Disorder questionnaire scores ranging from 0 to 21, and Hemoglobin A1c test results."
Answered by AI
Who else is applying?
What site did they apply to?
LifeLong Medical Care
What portion of applicants met pre-screening criteria?
Met criteria
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