Enhanced Primary Care and Resilience Clinic for Early Life Adversity and Caregiver Stress

Recruiting at 3 trial locations

Overseen By Joan J Jeung, MD

Age: < 18

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: 2

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Early life adversity can affect children's physical and mental health. The Resilience Clinic is a support program for young children and their caregivers who have been exposed to significant adversity, aiming to prevent the harmful effects of stress and improve child health, behavior, and development while also reducing caregiver stress. This study seeks to evaluate the Resilience Clinic, assessing the intervention's impact on child health, behavior, and development and caregiver stress and mental health.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Enhanced Primary Care and Resilience Clinic for Early Life Adversity and Caregiver Stress?

Research shows that primary care interventions promoting nurturing caregiving relationships can help reduce toxic stress and build resilience in children. Additionally, integrating adversity screening and parent coaching in pediatric primary care has been linked to fewer sick visits, suggesting improved health outcomes. ^{1 2 3 4 5}

Is the Enhanced Primary Care and Resilience Clinic safe for humans?

The available studies on similar interventions, like 'The Resiliency Clinic,' focus on promoting nurturing caregiving and resilience in children and do not report any safety concerns. These interventions are generally considered safe as they aim to support mental and physical health through education and support within primary care settings. ^{1 2 5 6 7}

How is the Resilience Clinic treatment different from other treatments for early life adversity and caregiver stress?

The Resilience Clinic is unique because it focuses on enhancing primary care with a group-based, psychoeducational approach that promotes nurturing caregiving relationships to mitigate toxic stress in children. Unlike traditional treatments, it integrates biological measures of stress responses to tailor interventions and improve child and caregiver behavioral health. ^{1 2 5 8 9}

Research Team

Joan Jeung, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for primary caregivers aged 18 and older who speak English or Spanish, with children between the ages of 2 to 5. The child must have a PEARLS score greater than 1 or have disclosed adversity to their clinician.

Inclusion Criteria

If you are a child between the ages of 2 and 5, and your PEARLS score is greater than 1 or you have told your doctor or their staff about any problems you are facing.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Caregiver-child dyads participate in the Resilience Clinic intervention, which includes psychoeducational activities aimed at mitigating toxic stress and promoting resilience.

8-12 weeks

Weekly sessions (in-person or community-based)

Follow-up

Participants are monitored for changes in child behavior, caregiver stress, and other health outcomes.

3 months

2 week and 3-month follow-up assessments

Treatment Details

Interventions

• Enhanced primary care
• Resilience Clinic

Trial Overview The study evaluates the Resilience Clinic, which supports young children and their caregivers exposed to significant adversity. It aims to mitigate stress effects on child health, behavior, development, and reduce caregiver stress.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Resilience Clinic

Group II: Control Active Control 1 Intervention

Enhanced pediatric primary care

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Population Health Innovation Lab

Collaborator

Trials

1

Recruited

200+

Asian Health Services

Collaborator

Trials

3

Recruited

420+

UCSF Benioff Children's Hospital Oakland

Collaborator

Trials

80

Recruited

19,100+

La Clínica de La Raza Inc.

Collaborator

Trials

4

Recruited

1,100+

UBCP Bancroft Pediatrics

Collaborator

Trials

1

Recruited

200+

Kerry's Kids

Collaborator

Trials

1

Recruited

200+

Findings from Research

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]

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 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 Mindfulness-based Wellness and Resilience (MBWR) intervention was found to be feasible and acceptable among 31 healthcare providers, with high satisfaction rates and successful completion of the 8-week program.

Participants reported multiple benefits from MBWR, including improved individual resilience, better team cohesion, and enhanced patient care, indicating its potential as a valuable tool in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based Wellness and Resilience intervention among interdisciplinary primary care teams: a mixed-methods feasibility and acceptability trial. Colgan, DD., Christopher, M., Bowen, S., et al.[2023]

The authors suggest that measuring biological stress responses in young children could significantly enhance pediatric care by providing more accurate assessments of the impact of adverse experiences on child wellbeing, beyond traditional rating scales.

While there are potential benefits to using these biological measures, there are also ethical concerns regarding their interpretation and the risk of mislabeling children, particularly those from disadvantaged backgrounds, highlighting the need for careful implementation in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translating the Biology of Adversity and Resilience Into New Measures for Pediatric Practice. Shonkoff, JP., Boyce, WT., Bush, NR., et al.[2022]

The Team Resource Management intervention, particularly when combined with Practice Enhancement Assistants, significantly reduced the overall rate of adverse drug events and moderate to severe preventable events in primary care settings over a 12-month period.

This study, which involved 12 practices and utilized a Trigger Tool chart review method, highlights the effectiveness of structured interventions in improving medication safety for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of self-empowered teams on rates of adverse drug events in primary care. Singh, R., Anderson, D., McLean-Plunkett, E., et al.[2021]

In a pilot study involving 180 primary care patients, 84 completed surveys revealed significant correlations between Adverse Childhood Experiences (ACEs), adult attachment styles, and health outcomes.

The study suggests that higher ACE scores are linked to poorer health and specific attachment styles, with a trend indicating a potential relationship with resilience, highlighting the need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personal characteristics associated with the effect of childhood trauma on health. Muench, J., Levy, S., Rdesinski, R., et al.[2019]

Children exposed to household adversities, such as a family member with cancer or psychiatric issues, are 1.38 times more likely to develop psychiatric problems compared to those without such adversities, based on a study following participants for an average of 12 years.

The study highlights the importance of proactive screening for psychiatric symptoms in children from families facing adversities, as these experiences are linked to increased healthcare encounters, indicating a need for more targeted support in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commonly occurring adversities in families as risk factors for developing psychosocial and psychiatric morbidities: evidence from general practice. Tendolkar, I., Polat, T., Peters, H., 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]

References

1. 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]

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

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

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. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based Wellness and Resilience intervention among interdisciplinary primary care teams: a mixed-methods feasibility and acceptability trial. [2023]

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

Translating the Biology of Adversity and Resilience Into New Measures for Pediatric Practice. [2022]

6. Egypt pubmed.ncbi.nlm.nih.gov

Effects of self-empowered teams on rates of adverse drug events in primary care. [2021]

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

Personal characteristics associated with the effect of childhood trauma on health. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Commonly occurring adversities in families as risk factors for developing psychosocial and psychiatric morbidities: evidence from general practice. [2022]

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

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