HealthySteps for Social Determinants of Health

(WBWF Trial)

Not currently recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Naval Health Research Center

Disqualifiers: Leaving service, Transferring locations, 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 a program called HealthySteps, which aims to assist military families with infants by connecting them to resources and support for parenting challenges. The researchers aim to determine if the program can improve parental involvement, increase awareness and use of family services, and enhance overall satisfaction for military parents. Families with infants aged 0-4 months who are TRICARE eligible and visit specific military clinics for well-baby care may be suitable for this study. Participants will either receive usual well-baby care or join the HealthySteps program, which provides more tailored support. As an unphased trial, this study offers families the chance to access potentially beneficial resources and support early on.

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 HealthySteps program is safe for families with infants?

Research has shown that the HealthySteps program is generally safe and well-tolerated. Studies have found that this program effectively identifies family needs early and connects families with necessary services without any reported safety concerns. The program has demonstrated positive results for children and their families, indicating its effectiveness in pediatric care settings.

The HealthySteps model offers varying levels of support based on each family's needs, with no reports of negative effects or major issues. This absence of negative feedback suggests that the program prioritizes user safety. Therefore, participants can feel confident that the program should not pose any unusual risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about HealthySteps for Social Determinants of Health because it offers a more comprehensive approach to pediatric care by addressing the social and emotional development of children, alongside standard health screenings. Unlike the typical guidelines from the American Academy of Pediatrics, which focus on physical health during well-baby visits, HealthySteps introduces a tiered intervention model that allows for personalized care based on each family's needs. This model includes specialized attention from HealthySteps Specialists, ensuring families with young children receive both targeted and comprehensive support, which could lead to better overall outcomes for child development.

What evidence suggests that the HealthySteps program is effective for improving parenting and well-baby care in military families?

Research has shown that the HealthySteps program, a treatment arm in this trial, can greatly enhance children's health and well-being. Studies have found that it aids in children's learning, movement, and physical growth. It also enhances early social and emotional development, crucial for healthy growth. Early results suggest that families using HealthySteps receive better parenting support and have easier access to necessary resources. These benefits have appeared in various locations, indicating that the program could be effective in diverse communities, including military families. ^{1 4 6 7 8}

Who Is on the Research Team?

Valerie A. Stander, Ph.D.

Principal Investigator

Naval Health Research Center

Are You a Good Fit for This Trial?

This study is for families with children aged 0-4 months who are receiving well-baby care at selected military pediatric clinics. It's open to all U.S. military service branch personnel and their families. The trial compares the effectiveness of a program called HealthySteps in a military setting against usual pediatric care.

Inclusion Criteria

English-speaking

TRICARE eligible

Seeking well-baby care at a participating military treatment facility pediatric clinic

Exclusion Criteria

Expecting to leave service or transfer locations/clinics within less than 6 months of WBWF enrollment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Recruitment and Enrollment

Recruitment of primary caregivers of newborns aged 0-4 months for the HealthySteps program and comparison group

2 years

In-person and remote recruitment at clinic visits

Data Collection

Collection of baseline, 6-month, and 12-month survey data from participants

12 months

Remote data collection via mail, email, and phone

Follow-up

Participants are monitored for outcomes such as well-baby care engagement and social determinants of health

First year of infant's life

What Are the Treatments Tested in This Trial?

Interventions

• HealthySteps

Trial Overview The trial is testing the HealthySteps program, which integrates educational support and resources into pediatric care to help parents with challenges like feeding and sleep. Families enrolled in this program at certain clinics are being compared to those receiving standard treatment at other locations.

How Is the Trial Designed?

Group I: HealthySteps Pilot Experimental Treatment 1 Intervention

The intervention arm included 3 tiers of targeted care following the HS model (https://www.zerotothree.org/our-work/healthysteps/). At tier 1, the standard Bright Futures screenings used in DoD pediatrics for children age 0 to 3 years were augmented to assess child social emotional development and family needs. For tiers 2 and 3, pediatricians/medical staff could refer eligible families with children aged 0 to 3 years to a HS Specialist either to address a specific issue requiring time-limited services (tier 2) or for comprehensive services (tier 3) to receive support at all well-child visits. Further, to meet the requirements of NDAA FY19, section 578, the HS Specialists were instructed to offer tier 3 services to all families of infants aged 0-4 months; this population was the WBWF intervention population eligible for the intervention arm of this study.

Group II: Treatment as usual Active Control 1 Intervention

DoD military treatment facility pediatric clinics follow American Academy of Pediatrics Bright Futures guidelines in providing well-baby care. The comparison arm of this study enrolled parents receiving treatment as usual under these guidelines at participating clinics assigned to this condition.

Who Is Running the Clinical Trial?

Naval Health Research Center

Lead Sponsor

Trials

21

Recruited

177,000+

Abt Global

Collaborator

Trials

1

Recruited

1,200+

Published Research Related to This Trial

The implementation of the Core 5 social risk screening tool in a presurgical spine population successfully identified social risk factors in 59% of patients, highlighting the importance of addressing social determinants of health before surgery.

Staff reported high usability and acceptance of the screening tool, with an average score of 4.4 out of 5, indicating that it can be effectively integrated into clinical workflows to connect patients with necessary resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing screening for social determinants of health using the Core 5 screening tool. Bradywood, A., Leming-Lee, TS., Watters, R., et al.[2021]

There is a significant gap in guidance for healthcare practitioners on how to address patients' social needs in clinical settings, despite evidence linking social circumstances to health outcomes.

The article proposes a three-tier framework for implementing social determinants interventions in healthcare, focusing on individual patients, healthcare institutions, and broader population strategies, along with methods for data collection and targeted interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collecting and applying data on social determinants of health in health care settings. Gottlieb, L., Sandel, M., Adler, NE.[2022]

Citations

1. healthysteps.org healthysteps.org/resource/healthysteps-outcomes-summary/

HealthySteps Evidence Summary HealthySteps improves child health and well-being by supporting perceptual, motor and physical development, strengthening early social-emotional development.

2. healthysteps.org healthysteps.org/resource/healthysteps-outcome-pilots-study/

HealthySteps Outcome Pilots Study The study assesses our model's influence on five outcomes important to healthy child development and family well-being.

3. healthysteps.org healthysteps.org/our-impact/the-evidence-base/

The Evidence Base - Early Childhood Development Science HealthySteps improves child health and well-being by supporting perceptual, motor and physical development, strengthening early social-emotional development, ...

4. files.eric.ed.gov files.eric.ed.gov/fulltext/EJ1220075.pdf

HealthySteps: Transforming the Promise of Pediatric Care Results from this research indicate that HealthySteps had an array of positive impacts on practices that adopted the program and clients they served, including.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38199577

Addressing adverse social determinants of health in pediatric ... We collect data at practice, clinician/staff, and parent levels to assess outcomes grounded in the Proctor Conceptual Model of Implementation Research. We ...

6. healthysteps.org healthysteps.org/our-impact/the-evidence-base/family-screening-and-connection-to-services/

Family Screening and Connection to Services Research on HealthySteps demonstrates that HealthySteps identifies family needs early and successfully connects families with services.

7. healthysteps.org healthysteps.org/what-we-do/our-model/tiers-and-core-components/

Tiers and Core Components The evidence-based HealthySteps model is organized into three Tiers of Service and eight Core Components to make sure all families in the practice with ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5865646/

An Integrative Review of Social Determinants of Health ... This review emphasizes the need for the continued development of effective, comprehensive and practical tools for assessing pediatric SDOH risk factors.