Well Baby, Well Family Study

NCT06801080 | Active Not Recruiting

• 1 other identifier: NHRC.2019.0021
• Study Type: interventional
• Target: 1,181
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Social Determinants of Health

Keywords

HealthySteps; New parent support; military children; social determinants of health

Outcome Measures

Primary Outcomes (16)

• Well-baby care engagement

  We examined appointment file data in medical records for participating families to document well-child care (WCC) adherence. This was operationalized as the extent to which beneficiary caregivers brought their infants into the clinic for recommended well-child visits (Current Procedural Terminology codes 99381 and 99391). On-time well child visits were flagged using a classification strategy modeled after Goyal (2020) and based on a slightly modified version of the Bright Futures recommended periodicity (Bright Futures, 2024). Note that in DoD Pediatrics the recommended 1-month well-child check is scheduled early at 2 weeks. Expected timeframes were as follows: Visit1: 0-7 days; Visit2: 8-41 days; Visit3: 42-90 days; Visit4: 91-150 days; Visit5: 151-210 days; and Visit6: 211-335 days.

  First year of infant's life

• Timely vaccinations

  Adherence to infant vaccination schedules was evaluated as a benchmark metric for pilot program implementation success. The receipt of ten different pediatric vaccine series was documented from health records for infants at participating clinics, including Hepatitis A, Hepatitis B, Rotavirus, Diphtheria/Tetanus/Pertussis, Haemophilius Influenzae Type b, Pneumococcal Conjugate Vaccine, Polio, Measles/Mumps/Rubella, Varicella, and COVID. Using a classification strategy modeled after Romano et. al. (2022), Initial vaccine doses were considered on-time if they occurred prior to or no later than 4 days after the recommended age; similarly, follow-up doses were timely if they occurred prior to or no later than 4 days after the recommended interval. recommended vaccinations received within expected timeframes.

  First year of infant's life

• Emergency room visits

  We created an emergency room visit indicator documenting trips to the emergency room for infants in either the HS condition or control group conditions. Data for this indicator were extracted from archival medical records regarding medical encounters at MTF treatment facilities.

  First year of infant's life

• Social determinants of health

  Social determinants of health were evaluated using a modified 10-item version of the family needs assessment on the Tufts Survey of Well-being of Young Children (SWYC; Tufts Medicine, 2024). This section of the SWYC covers issues such as food insecurity, and parental well-being (e.g., substance use, marital quality/conflict). For the DoD HS pilot, participating pilot clinics were asked to use an augmented version of the SWYC family needs screener including 3 additional items regarding financial insecurity (i.e., housing, bills, and transportation). This augmented set of items was included on the WBWF study surveys at each time point. Note that as used in clinic screening and as a study outcome, total scores were not computed; rather a positive response to any of the 10 items was indicative of need.

  First year of infant's life

• Military life stress

  Based on a measure adapted from the Millennium Cohort Family Study (Corry, 2017; 2021), the WBWF asked parents regarding the stresses of military life, and in particular included a single item assessing the overall recent stress level ("In general, how stressful do you feel military life has been for you and your family over the past 6 months?" response options: 1 = not at all stressful to 5 = extremely stressful).

  First year of infant's life

• Parental depression

  The Patient Health Questionnaire (Spitzer, 1999) 2-item screen for depression was used to asses for parental symptoms of depression at each survey timepoint. Respondents indicate the frequency of two key symptoms; (1) little interest or pleasure in doing things and (2) feeling down, depressed or hopeless. Responses options are on a 4-point scale ranging from "not at all" to "nearly every day." Higher total scores (range = 2 to 8) indicate more frequent symptomology.

  Infant's first year of life

• Parenting quality: Attunement

  The Attunement subscale of the Baby Care Questionnaire (Winstanley \& Gattis, 2013) was used to assess the quality of participants parenting in caring for their newborns. Specifically, this subscale operationalizes parental sensitivity to infant cues and attentional states in parenting interactions. Scores on the Attunement subscale range from 0 to 70, with higher scores more clinically favorable.

  Infant's first year of life

• Parenting quality: Structure

  The Structure subscale of the Baby Care Questionnaire (Winstanley \& Gattis, 2013) was additionally used to assess quality of parenting. This subscale operationalizes use of regularity and routines in infant care. Scores on the Structure subscale range from 0 to 85, with higher scores more clinically favorable.

  Infant's first year of life

• Parenting competence: Efficacy

  The Efficacy subscale from the Parenting Sense of Competence measure (Johnston \& Mash, 1989) was used to assess new parents experiences in caring for their newborns, and in particular, their sense of instrumental competence, problem-solving ability, and capability in their caregiving role. Scores on the Efficacy subscale range from 0 to 28, with higher scores more clinically favorable.

  Infant's first year of life

• Parenting Competence: Satisfaction

  The Satisfaction subscale from the Parenting Sense of Competence measure (Johnston \& Mash, 1989) was used to assess new parents experiences in caring for their newborns, and in particular, their sense of affective frustration, anxiety, and motivation in their caregiving role. Scores on the Satisfaction subscale range from 0 to 28, with higher scores more clinically favorable.

  Infant's first year of life

• Augmented referrals

  Improving processes for targeted referrals is a primary objective of the HS program and we assessed the percentage of families at HS pilot versus comparison locations receiving referrals to specific support services, including important military-specific support programs (e.g., DoD New Parent Support Program).

  Infant's first year of life

• Work-family conflict

  Participants responded to 5 true/false items from the Work-Family Conflict Scale (Netemeyer et al., 1996) modified to apply to military life (e.g., my deployment-related travel \[30 days or more\] interferes with our home and family life). This measure was originally adapted for use in the Millennium Cohort Family Study. Response options were on a 5-point Likert type scale from 1 = strongly disagree to 5 = strongly agree (Sum scores range from 5-25, with higher scores indicating more conflict).

  First year of infant's life

• Infant difficulty

  A modified assessment of parent perceptions regarding how difficult their infant was to care for was included from the National Survey of Children's Health (Data Resource Center of Child and Adolescent Health, 2024). Scores from this 3-item subscale range from 0 to 12, with higher scores more unfavorable.

  First year of infant's life

• Protective factors: Family functioning

  Family strengths and resources potentially protective against child maltreatment were assessed with the Protective Factors Survey (Counts, 2010) including a module regarding family functioning. Scores on this subscale range from 0 to 12, with higher scores more clinically favorable.

  Infant's first year of life

• Protective factors: Nurturing and attachment

  Family strengths and resources potentially protective against child maltreatment were assessed with the Protective Factors Survey (Counts, 2010) including a module regarding nurturing and attachment. Scores on this subscale range from 0 to 16, with higher scores more clinically favorable.

  Infant's first year of life

• Protective factors: Social support

  Family strengths and resources potentially protective against child maltreatment were assessed with the Protective Factors Survey (Counts, 2010) including a module regarding social support resources. Scores on this subscale range from 0 to 16, with higher scores more clinically favorable.

  Infant's first year of life

Study Arms (2)

HealthySteps Pilot

EXPERIMENTAL

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.

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

Treatment as usual

ACTIVE COMPARATOR

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.

Other: Treatment as Usual (TAU)

Interventions

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

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.

HealthySteps Pilot

Treatment as Usual (TAU) OTHER

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.

Treatment as usual

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• TRICARE eligible
• English-speaking
• Parent of an infant aged 0-4 months
• Seeking well-baby care at a participating military treatment facility pediatric clinic
• Expecting to be the caregiver most often attending well-baby appointments

You may not qualify if:

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

Sponsors & Collaborators

• Naval Health Research Center: lead
• Abt Global: collaborator

Study Sites (2)

Naval Health Research Center

San Diego, California, 92106, United States

Location

Abt Global

Rockville, Maryland, 20852, United States

Location

Related Publications (11)

• HealthySteps National Office. (2018). HealthySteps Implementation Guide. Author.

  BACKGROUND

• Winstanley A, Gattis M. The Baby Care Questionnaire: a measure of parenting principles and practices during infancy. Infant Behav Dev. 2013 Dec;36(4):762-75. doi: 10.1016/j.infbeh.2013.08.004. Epub 2013 Sep 18.

  PMID: 24050932 BACKGROUND

• Johnston C and Mash EJ. A measure of satisfaction and efficacy. (1989). Journal of ClinicalPsychology. 18 (2),167-175.

  BACKGROUND

• Counts JM, Buffington ES, Chang-Rios K, Rasmussen HN, Preacher KJ. The development and validation of the protective factors survey: a self-report measure of protective factors against child maltreatment. Child Abuse Negl. 2010 Oct;34(10):762-72. doi: 10.1016/j.chiabu.2010.03.003. Epub 2010 Sep 19.

  PMID: 20851466 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB. Validation and utility of a self-report version of PRIME-MD: the PHQ primary care study. Primary Care Evaluation of Mental Disorders. Patient Health Questionnaire. JAMA. 1999 Nov 10;282(18):1737-44. doi: 10.1001/jama.282.18.1737.

  PMID: 10568646 BACKGROUND

• Netemeyer, R. G., Boles, J. S., & McMurrian, R. (1996). Development and validation of Work-Family Conflict and Family-Work Conflict Scales. Journal of Applied Psychology, 81(4), 400-410.

  BACKGROUND

• Corry NH, Williams CS, Radakrishnan S, McMaster HS, Sparks AC, Briggs-King E, Karon SS, Stander VA. Demographic Variation in Military Life Stress and Perceived Support Among Military Spouses. Mil Med. 2021 Jan 25;186(Suppl 1):214-221. doi: 10.1093/milmed/usaa386.

  PMID: 33499525 BACKGROUND

• Tufts Medicine. (2024). The Survey of Well-being of Young Children. Retrieved September 19 from https://www.tuftsmedicine.org/medical-professionals-trainees/academic-departments/department-pediatrics/survey-well-being-young-children

  BACKGROUND

• Romano CJ, Bukowinski AT, Hall C, Burrell M, Gumbs GR, Conlin AMS, Ramchandar N. Brief Report: Pediatric Vaccine Completion and Compliance Among Infants Born to Female Active Duty Service Members, 2006-2016. MSMR. 2022 Nov 1;29(11):18-22. No abstract available.

  PMID: 36790926 BACKGROUND

• Goyal NK, Rohde JF, Short V, Patrick SW, Abatemarco D, Chung EK. Well-Child Care Adherence After Intrauterine Opioid Exposure. Pediatrics. 2020 Feb;145(2):e20191275. doi: 10.1542/peds.2019-1275. Epub 2020 Jan 2.

  PMID: 31896548 BACKGROUND

• Bright Futures. (2024). Recommendations for preventive pediatric health care. In Amer Acad of Pediatrics: Author.

  BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

• Valerie A. Stander, Ph.D.

  Naval Health Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Compliance administrator, Deployment Health Department

Model Details: This was a quasi-experimental study of military parents with a newborn infant seeking care at DoD HS pilot program implementation pediatric clinics as well as pediatric clinics at military treatment facilities implementing treatment as usual. The target population included parents with an infant aged 0-4 months scheduling well-baby care at one of 7 pilot and 11 comparison clinics. Participation in both the HS pilot services and the WBWF study was voluntary.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 30, 2025
• Study Start: January 5, 2022
• Primary Completion: January 31, 2024
• Study Completion: May 31, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)