HealthySteps for Social Determinants of Health
(WBWF Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byValerie A. Stander, Ph.D.

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Naval Health Research Center

No Placebo Group

Trial Summary

What is the purpose of this trial?BACKGROUND: The Defense Health Agency (DHA) and the Office of Military Community and Family Policy (MC\&FP) requested assistance in evaluating the effectiveness of a military pilot implementation of a civilian program designed to assist families with infants called HealthySteps (HS; HealthySteps National Office, 2018). HS is a unique pediatric primary care-based program that helps families identify and manage parenting challenges. The program interweaves the medical support of the pediatrician's office with the resources and services of a HS Specialist trained to help parents understand their infants' needs (e.g., feeding, behavior, sleep) and their role as caregivers. HS Specialists provide enhanced educational support and facilitate targeted referrals to other relevant DoD and civilian support resources. OBJECTIVE: The HS program has not been widely implemented or evaluated previously in a military context. However, a small 2-site pilot was initiated in 2017 by MC\&FP to assess the feasibility of offering the HS program in military treatment facilities (MTF). The Defense Health Agency (DHA) further determined that this pilot program could be expanded to fulfill a 2019 National Defense Authorization Act (NDAA) requirement for the implementation and evaluation of a pilot program to reduce risk factors for child abuse and neglect within the U.S. military community. APPROACH: This outcome evaluation study entailed a review of medical records for families enrolled in the HS pilot as well as the collection of prospective survey data. Survey data collected from primary caregivers enrolled in HS at seven implementation locations throughout the U.S. is being compared with survey data collected from caregivers of newborns seeking care at control locations offering pediatric treatment as usual. VALUE: The HS program is expected to improve parental engagement in well-baby care, increase targeted screenings and referrals, improve parental efficacy and knowledge, as well as facilitate integration and utilization of existing family services available across disparate military support settings. It also is expected to increase military service satisfaction and perceived support among military parents. Summary reports of study results will be provided to MC\&FP, DHA, and Congress. RESEARCH COLLABORATORS: NHRC is a Department of the Navy Bureau of Medicine and Surgery research command located in San Diego, California. Abt Global is a leading civilian professional research corporation with extensive experience in military health research. Investigators from these two institutions are collaborating to conduct this outcome evaluation. STUDY POPULATION: Participating pilot program clinics included 7 military pediatric clinic locations selected by DHA and serving personnel and their families from all U.S. military service branches. All families with children aged 0-4 months seeking well-baby care at participating MTF pilot pediatric clinics were eligible for HS program services and for study recruitment. Additionally, beneficiaries similarly seeking care for a newborn at 11 MTF pediatric clinics providing treatment as usual were eligible for the comparison condition. Medical records for this population were reviewed and prospective survey evaluation data were collected and merged together for ongoing analysis and reporting.

Eligibility Criteria

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

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

TRICARE eligible

+2 more

Exclusion Criteria

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

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: HealthySteps PilotExperimental Treatment1 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 usualActive Control1 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.