Well Baby, Well Family Study
Public ClinicalTrials.gov record NCT06801080. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06801080
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,181 participants
Conditions and interventions
Conditions
Interventions
- HealthySteps (https://www.zerotothree.org/our-work/healthysteps/) Other
- Treatment as Usual (TAU) Other
Other
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 4, 2022
- Primary completion
- Jan 30, 2024
- Completion
- May 30, 2025
- Last update posted
- Mar 10, 2025
2022 – 2025
United States locations
- U.S. sites
- 2
- U.S. states
- 2
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Naval Health Research Center | San Diego | California | 92106 | — |
| Abt Global | Rockville | Maryland | 20852 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06801080, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 10, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06801080 live on ClinicalTrials.gov.