Resilience-Building Interventions for Early Life Adversity

(CARE Trial)

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

300 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the treatment Caregiver-child Intervention, Enhanced Primary Care, Enhanced Primary Care, E-PRIME for resilience-building in children facing early life adversity?

Research shows that primary care interventions promoting nurturing caregiving relationships can help reduce toxic stress and improve resilience in children. A study on a similar intervention, 'The Resiliency Clinic,' found it feasible and acceptable, with potential positive effects on child and caregiver behavioral health. Additionally, a psychoeducational parenting group in a primary care setting showed significant improvements in family functioning and child behavior, suggesting such interventions can be effective. ^{1 2 3 4 5}

Is the Resilience-Building Intervention for Early Life Adversity safe for humans?

The studies reviewed focus on the feasibility and acceptability of interventions like Parent Connext and The Resiliency Clinic, which are similar to the Resilience-Building Intervention. These interventions are generally considered safe as they involve psychoeducational support and parent coaching within primary care settings, with no reported adverse effects. ^{2 3 5 6 7}

How is the treatment Caregiver-child Intervention, Enhanced Primary Care (E-PRIME) different from other treatments for early life adversity?

The Caregiver-child Intervention, Enhanced Primary Care (E-PRIME) is unique because it focuses on building nurturing caregiving relationships and early relational health to mitigate toxic stress in children, using a group-based, psychoeducational approach within primary care settings. This treatment emphasizes the role of caregivers and integrates adversity screening and parent coaching, which is not typically a focus in standard treatments for early life adversity. ^{2 3 5 6 8}

Research Team

Neeta Thakur, MD, MPH

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

I am the main caregiver, over 18, speak English or Spanish, and my child is aged 2-5 with specific health needs.

I am over 18, the main caregiver, and speak English or Spanish. My child is aged 2-4 with a PEARLS score over 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)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Integrated CARE: Adaptation of Child-Adult Relationship Enhancement (CARE) Model for Use in Integrated Behavioral Pediatric Care. [2021]

2. United States 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. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Primary care experiences of women with a history of childhood trauma and chronic disease: Trauma-informed care approach. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a psychoeducational parenting group on child, parent, and family behavior: a pilot study in a family practice clinic with an underserved population. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Caregiver-Child Intervention for Mitigating Toxic Stress ("The Resiliency Clinic"): A Pilot Study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Primary Care Interventions to Prevent or Treat Traumatic Stress in Childhood: A Systematic Review. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Co-located Parent Coaching Services Within Pediatric Primary Care: Feasibility and Acceptability. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Training Psychologists in Integrated Primary Care and Child Maltreatment: Trainee and Supervisor Perspectives on Lessons Learned. [2021]