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

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a special support program, the Resilience Clinic, aids young children and their caregivers who have faced early life challenges. The goal is to enhance children's health, behavior, and development while reducing stress and improving caregivers' mental health. The trial will compare the Resilience Clinic to regular enhanced pediatric care (enhanced primary care) to determine which is more effective. Families may be suitable if they have children aged 2 to 5 who have encountered significant early challenges, as indicated by a PEARLS score or a discussion with their doctor. As an unphased trial, this study provides families with a unique opportunity to contribute to understanding and improving support systems for young children and caregivers.

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 prior data suggests that the Resilience Clinic is safe for children and caregivers?

Research has shown that programs like the Resilience Clinic can help reduce stress and build resilience in children, which is crucial because stress can negatively affect health. The Resilience Clinic is a group program that focuses on improving relationships and supporting families.

In earlier studies, participants generally did not experience any serious side effects from the Resilience Clinic. The program aims to support both children and caregivers by focusing on mental and emotional health. While specific safety data is limited, similar programs have demonstrated safety and effectiveness for families dealing with stress.

Overall, the Resilience Clinic appears to be a safe option for those seeking to support their child's health and development while managing their own stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Resilience Clinic because it introduces an innovative approach to addressing early life adversity and caregiver stress. Unlike standard treatments that might focus on immediate medical interventions, this clinic emphasizes building long-term resilience through supportive care and stress management techniques. By targeting the underlying stressors and promoting resilience, the clinic aims to improve overall well-being and reduce the impact of adversity over time. This holistic and preventative method could offer a more sustainable solution compared to traditional reactive treatments, potentially transforming how we support individuals facing these challenges.

What evidence suggests that the Resilience Clinic could be effective for early life adversity and caregiver stress?

Research shows that the Resilience Clinic, available to participants in this trial, is a group support program that enhances children's health, behavior, and development. It emphasizes building strong, healthy relationships between children and their caregivers. Studies have found that such programs can reduce the harmful effects of stress and increase resilience in children. Previous research also shows improvements in caregiver stress and mental health. These findings suggest that the Resilience Clinic could mitigate the negative impacts of early life challenges. Meanwhile, the control group in this trial will receive enhanced pediatric primary care, serving as an active comparator. ^{1 4 5 6 7}

Who Is on the Research Team?

Joan Jeung, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11833186/

A Primary Care Group Resilience Intervention Promotes ... This pilot study of the redesigned Resilience Clinic, a group-based psychoeducational intervention designed to promote relational health and child and family ...

2. withpower.com withpower.com/trial/phase-early-life-adversity-2-2023-21c78

Enhanced Primary Care and Resilience Clinic for Early Life ... Research shows that primary care interventions promoting nurturing caregiving relationships can help reduce toxic stress and build resilience in children.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06669624

Study Details | NCT06669624 | Resilience Through ... Participants will include primary caregivers fluent in English or Spanish, along with their children who have experienced social risk factors for adversity.

4. pediatrics.jmir.org pediatrics.jmir.org/2025/1/e67638

A Primary Care Group Resilience Intervention Promotes Child ... This pilot study of the redesigned Resilience Clinic, a group-based psychoeducational intervention designed to promote relational health and child and family ...

5. clinicaltrials.ucbraid.org clinicaltrials.ucbraid.org/trial/NCT05690256

Resilience Clinic Evaluation - UC Clinical Trials This study seeks to evaluate the Resilience Clinic, assessing the intervention's impact on child health, behavior, and development and caregiver stress and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05259436

Study Details | NCT05259436 | Collaborative Approach to ... To examine the behavioral, psychosocial, and biologic impact of resilience-promoting interventions associated with primary care. Detailed Description. Early- ...

7. ctv.veeva.com ctv.veeva.com/study/the-resilience-clinic-evaluation

The Resilience Clinic Evaluation - ClinicalTrials.Veeva The aim of this primary-care based intervention is to prevent or mitigate the toxic stress response, thus promoting child resilience in the face ...