Resilience-Building Interventions for Early Life Adversity

(CARE Trial)

Not currently recruiting at 3 trial locations

Overseen By Daniel Correa Bucio, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Immunomodulators, Chemo, Radiation, Hormonal

Disqualifiers: Active suicidality, Psychiatric issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how resilience-building interventions can improve behavior, psychosocial health, and biological responses in young children who have faced early life challenges. It tests two treatments: a Caregiver-Child Intervention, focusing on various settings and delivery methods, and Enhanced Primary Care, which supports families in connecting with social resources. Families with young children (aged 2 to 5) who have faced adversity and can access digital devices for potential telehealth sessions might be a good fit. As an unphased trial, this study offers families the chance to contribute to innovative research that could enhance support systems for young children facing adversity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you or your child have significant medical conditions requiring treatments like immunomodulators, chemotherapy, or hormonal therapy, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Caregiver-Child Intervention addresses early life challenges. In studies, caregivers noted that children often encountered many difficult experiences. Although these experiences can be challenging, the intervention aims to help both caregivers and children build resilience. Importantly, studies found no evidence of harm or negative effects from the intervention.

For the Enhanced Primary Care approach, which assists families in finding social support services, specific safety data is unavailable. However, because it helps families access resources, it is likely to be well-received. Generally, services that support families in this way are considered safe and helpful.

In summary, both interventions focus on providing support and building resilience. They are expected to be safe, with no known risks reported in the research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for early life adversity because they offer new ways to support both caregivers and children. The Caregiver-Child Intervention is unique because it explores different settings, like home versus clinic, and delivery methods, such as one-on-one or group sessions, to see how these factors affect outcomes. This multifaceted approach could lead to more tailored and effective support strategies. On the other hand, Enhanced Primary Care focuses on connecting families with social resources, which can address underlying social needs that often accompany early life adversity. These innovative interventions could provide more comprehensive and adaptable support than standard care options.

What evidence suggests that this trial's treatments could be effective for early life adversity?

Research shows that programs involving both caregivers and children can significantly enhance children's resilience when facing early life challenges. In this trial, participants may receive the Caregiver-Child Intervention, which helps caregivers respond more effectively to their children's needs, resulting in improved social and behavioral outcomes for the children. For example, the "Supporting Early Learning Study" found that such programs benefited both caregivers and children. Additionally, research highlights the crucial role caregivers play in helping children build resilience, especially when both have experienced difficult childhoods. Overall, these findings suggest that caregiver-child programs can effectively support children's growth in challenging situations. ^{2 6 7 8 9}

Who Is on the Research Team?

Neeta Thakur, MD, MPH

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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)

Exclusion Criteria

My caregiver does not have active suicidal thoughts or psychiatric issues.

My child has a serious health condition needing strong medication or therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive one of three resilience-promoting, caregiver-child interventions: Resilience Clinic, Attachment and Biobehavioral Catch-up, or Resiliency Family Program

12 weeks

Follow-up

Participants are monitored for psychosocial, behavioral, and biological outcomes after intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Caregiver-child Intervention
• Enhanced Primary Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Caregiver-Child Intervention Experimental Treatment 1 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 Care Active Control 1 Intervention

Navigational services for social need resources.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Lifelong Medical Care

Collaborator

Trials

3

Recruited

730+

UCSF Benioff Children's Hospital Oakland

Collaborator

Trials

80

Recruited

19,100+

Santa Barbara Neighborhood Clinics

Collaborator

Trials

1

Recruited

300+

University of California, Santa Barbara

Collaborator

Trials

33

Recruited

3,100+

Futures Without Violence

Collaborator

Trials

3

Recruited

8,600+

Published Research Related to This Trial

The Parent Connext program was successfully implemented in 11 pediatric practices, screening 13,346 visits, with 26% of families identified as having parenting and psychosocial concerns, demonstrating its feasibility in a primary care setting.

After the program, providers reported feeling more supported and confident in addressing family concerns, and 48% of referred families received individualized coaching, indicating the program's positive impact on both healthcare providers and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-located Parent Coaching Services Within Pediatric Primary Care: Feasibility and Acceptability. Eismann, EA., Folger, AT., Shapiro, RA., et al.[2021]

The pilot study of 'The Resiliency Clinic' involved 101 eligible families, with 38 families (37.6%) participating and attending an average of 3 out of 6 sessions, indicating that the program is feasible and acceptable for many families.

While caregivers reported high satisfaction and some benefits from the program, the improvements in caregiver stress and child executive functioning were modest and not statistically significant, suggesting that while the intervention shows promise, further development is needed to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Caregiver-Child Intervention for Mitigating Toxic Stress ("The Resiliency Clinic"): A Pilot Study. Jeung, J., Hessler Jones, D., Frame, L., et al.[2022]

The Parent Connext program, which integrates adversity screening and parent coaching in pediatric primary care, significantly reduced the number of sick visits for children under age 8, indicating its effectiveness in improving child health outcomes.

While the program led to fewer sick visits, it unexpectedly decreased adherence to well-child visits but increased the likelihood of referrals, suggesting a complex impact on healthcare utilization that warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Screening and Co-located Parent Coaching Within Pediatric Primary Care on Child Health Care Use: A Stepped Wedge Design. Eismann, EA., Zhang, B., Fenchel, M., et al.[2023]

A systematic review of 10 studies involving interventions for child traumatic stress in primary care settings found that 9 out of 10 studies reported positive outcomes, indicating that these interventions can effectively support pediatric patients and their families.

Interventions included screening programs, clinician training, and resource provision, demonstrating that implementing such strategies in primary care is feasible and beneficial, although the studies had short follow-up periods and varied methodologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary Care Interventions to Prevent or Treat Traumatic Stress in Childhood: A Systematic Review. Flynn, AB., Fothergill, KE., Wilcox, HC., et al.[2018]

A qualitative study involving 26 women with a history of childhood trauma and chronic disease revealed that most had not been asked about their adverse childhood experiences (ACEs) by their family physicians, despite believing these experiences significantly impacted their health.

The study highlighted the need for a trauma-informed approach in primary care, as participants expressed that their care experiences often did not align with trauma-informed principles, suggesting that physicians should routinely inquire about childhood experiences to improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Primary care experiences of women with a history of childhood trauma and chronic disease: Trauma-informed care approach. Purkey, E., Patel, R., Beckett, T., et al.[2023]

The IntegratedCARE model, adapted from the Child-Adult Relationship Enhancement (CARE) interaction model, was successfully implemented in primary care settings, providing a brief 3-session treatment to 30 parent-child dyads.

Participants showed significant improvements in child behavior, as indicated by decreased scores on the Eyberg Childhood Behavior Inventory, and reported high satisfaction with the treatment, suggesting that IntegratedCARE is both effective and feasible for use by trained professionals in routine primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated CARE: Adaptation of Child-Adult Relationship Enhancement (CARE) Model for Use in Integrated Behavioral Pediatric Care. Scott, B., Gurwitch, RH., Messer, EP., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12551162/

Measuring adverse and protective experiences in early ... The present study aimed to address current challenges in ACE measurement and screening, particularly the need for a caregiver-report tool that ...

2. publications.aap.org publications.aap.org/pediatrics/article/155/2/e2024068578/200622/Caregiver-and-Child-Adverse-Childhood-Experiences

Caregiver and Child Adverse Childhood Experiences Results of our moderator analyses suggested that the association between caregiver and child ACEs was stronger among younger vs older caregivers ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04107506

NCT04107506 | The Supporting Early Learning Study Aim 1: Quantify main effects of FIND on intervention targets (changes in responsive caregiving) and related caregiver and child outcomes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10872788/

Leveraging the developmental neuroscience of caregiving to ... Here we propose that caregivers play a central role in fostering resilience among children exposed to adversity via caregiving influences.

5. stacks.cdc.gov stacks.cdc.gov/view/cdc/128654/cdc_128654_DS1.pdf

Associations between Caregiver ACEs and Child ... The results of these studies provide empirical support for the intergenerational link between a caregiver's early childhood adversity and their children's ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9489544/

A Caregiver-Child Intervention for Mitigating Toxic Stress ... By study design, all caregivers reported at least one child adversity with a median report of 4 (interquartile range 1–5) adversities. Nearly ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10327383/

A data-driven approach to categorizing early life adversity ... We employed an exploratory factor analysis to identify the factor domains of early life adversity exposure and conducted a series of regression ...

8. nature.com nature.com/collections/agihhdhddh

Health outcomes of adversity in early life Three out of four children will experience at least one adverse childhood experience, and around one in five children will experience four or more adverse ...

9. cdc.gov cdc.gov/aces/risk-factors/index.html

Risk and Protective Factors | Adverse Childhood ... A combination of factors at the individual, relationship, community, and societal levels can increase or decrease the risk of violence.