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ACTIVE NOT RECRUITING
NCT06801080
NA

Well Baby, Well Family Study

Sponsor: Naval Health Research Center

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1181

Start Date

2022-01-05

Completion Date

2025-05-31

Last Updated

2025-03-11

Healthy Volunteers

Yes

Interventions

OTHER

HealthySteps (https://www.zerotothree.org/our-work/healthysteps/)

Within the DoD, most elements of the civilian HS model copyrighted by ZeroToThree.org were implemented. However, there were some modifications to accommodate the unique environment of the military community. The pilot utilized the pre-existing Military Family Life Counseling Program (MFLC) staff to serve as HS Specialists at participating clinics. MFLCs were hired and trained in the HS model through the HS Institute provided by ZeroToThree.org. Although the DoD pilot offered all 3 tiers of targeted care standard for the HS model, note that the DoD pilot did not offer a 24-hour parent support line at tier 1. Also, the DoD pilot required participating pilot clinics to utilize a modified version of the Tufts Survey of Well-Being of Young Children (SWYC; https://www.tuftsmedicine.org/medical-professionals-trainees/academic-departments/department-pediatrics/survey-well-being-young-children) to provide augmented screenings for infants at all tiers of pilot service provision.

OTHER

Treatment as Usual (TAU)

The comparison clinics included in this intervention were selected to represent pediatric care within military treatment facilities throughout the DHA medical system located at Army, Navy, Marine Corps, and Air Force facilities. There is variability in pediatric practice across military service branches. However, all clinics follow the American Academy of Pediatrics Bright Futures guidelines.

Locations (2)

Naval Health Research Center

San Diego, California, United States

Abt Global

Rockville, Maryland, United States