Home Visitation Program for New Parent Support

Overseen By Daniel F Perkins, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penn State University

Disqualifiers: Under 18, Not military, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of a new home-visiting program for new parents in the Navy and Marine Corps. It aims to determine if the Take Root Home Visitation (TRHV) program improves child development, enhances parenting behaviors, and reduces the risk of child maltreatment compared to usual services. The trial will also assess parent and clinician satisfaction with the program and its implementation. This trial suits active duty, retired, National Guard, or Reserves service members or their spouses who are pregnant or have a child aged 0-3 years and qualify for home-visiting services. As an unphased trial, this study offers an opportunity to contribute to valuable research that could enhance support services for military families.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on evaluating a home visitation program rather than medical treatments.

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 Take Root Home Visitation (TRHV) program is safe and effective?

In a previous study, trained professionals used the Take Root Home Visitation (TRHV) program to support new military parents. The program assists families with babies and toddlers. Research has shown that both the professionals delivering the program and the participating families find it beneficial.

The TRHV training is comprehensive, lasting 17 hours, to ensure thorough preparation for those implementing the program. Although specific safety data for TRHV is not detailed, its use in military settings and structured training suggest it is safe and well-received.

TRHV is designed to support parenting rather than serve as a medical treatment, so it lacks the usual medical risks. Instead, it aims to enhance parenting skills and reduce the risk of child maltreatment. Overall, TRHV is considered safe for families. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Take Root Home Visitation (TRHV) program because it offers a structured, evidence-informed approach to supporting new parents, which is different from the typical "services as usual" (SAU) provided at military installations. Unlike standard care that relies on existing resources without a specific curriculum, TRHV provides a manualized home-visiting curriculum designed to systematically address the needs of new parents. This unique feature has the potential to provide more consistent and comprehensive support, which could lead to better outcomes for both parents and children.

What evidence suggests that the Take Root Home Visitation program is effective for new parent support?

Research has shown that home visitation programs, such as Take Root Home Visitation (TRHV), which participants in this trial may receive, can improve health habits during pregnancy, strengthen parent-child relationships, and reduce child abuse and neglect. Initial findings suggest that TRHV helps families build trust and supports ongoing learning and well-being. Evidence indicates that these programs are effective and beneficial for military families with young children. Past studies have demonstrated that these programs are designed to lower the risk of child maltreatment and improve parenting skills. Overall, TRHV aims to effectively support new parents by offering a structured and evidence-based approach. ^{1 3 4 6 7}

Who Is on the Research Team?

Daniel F Perkins, PhD

Principal Investigator

The Pennsylvania State University

Ryan P Chesnut, PhD

Principal Investigator

The Pennsylvania State University

Are You a Good Fit for This Trial?

This trial is for families with children aged 0-3, or expecting parents, who are active duty, retired, National Guard or Reserves service members (or their partners) stationed at certain military installations. They must speak English well and be eligible for the New Parent Support Program home visits.

Inclusion Criteria

NPSP Home Visitors: Speak and understand English proficiently

NPSP Participants: Eligible to receive NPSP home-visiting services

My child is between 0 and 3 years old.

Exclusion Criteria

My child is older than 3 years.

NPSP Participants: Not currently pregnant or the parent of a child 0-3-years-old

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessments including various questionnaires and inventories to establish baseline measures

1-2 weeks

Treatment

Participants receive either the TRHV or SAU home-visiting services

12 months

Follow-up

Participants are monitored for program outcomes and client satisfaction post-treatment

6-7 months post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Services as Usual (SAU)
• Take Root Home Visitation (TRHV)

Trial Overview The study evaluates a new program called Take Root Home Visitation (TRHV), which aims to improve child development and parenting behaviors while reducing child abuse risk. It will be compared to the usual support services provided by the military.

How Is the Trial Designed?

Group I: Take Root Home Visitation (TRHV) Experimental Treatment 1 Intervention

TRHV is an evidence-informed, manualized home-visiting curriculum.

Group II: Services as Usual (SAU) Active Control 1 Intervention

SAU involves the current standard of care implemented at the participating Navy and Marine Corps installations.

Who Is Running the Clinical Trial?

Penn State University

Lead Sponsor

Trials

380

Recruited

131,000+

United States Department of Agriculture (USDA)

Collaborator

Trials

103

Recruited

287,000+

Published Research Related to This Trial

The Hawaii Healthy Start Program successfully identified 84% of at-risk families through early screening, with higher enrollment rates among families with greater risk factors, such as young mothers with limited education and infants at biological risk.

Engagement in home visiting services was variable, with about half of enrolled families remaining active after one year, and those facing multiple risk factors were more likely to have frequent visits, highlighting the need for tailored support to retain at-risk families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hawaii's healthy start program of home visiting for at-risk families: evaluation of family identification, family engagement, and service delivery. Duggan, A., Windham, A., McFarlane, E., et al.[2014]

The paper emphasizes the importance of establishing a coordinated national policy for family support at home, highlighting the historical context of home visiting programs.

It provides recommendations for improving practice, training, and research in family support programs, while also discussing the influence of new federal initiatives on these efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family support in the home. Programs, policy, and social change. Roberts, RN., Wasik, BH., Casto, G., et al.[2019]

In a study of 816 participants in a national home visitation program, factors such as being older, unemployed, or enrolling early in pregnancy were linked to longer service duration and more home visits, indicating these characteristics may enhance program retention.

Programs with lower caseloads and better matching of participants and providers based on parenting status and race/ethnicity showed improved enrollment and retention rates, highlighting the importance of tailored support in home visitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustaining new parents in home visitation services: key participant and program factors. Daro, D., McCurdy, K., Falconnier, L., et al.[2019]

The Nurse-Family Partnership program showed a significant reduction in subsequent pregnancies for first-time mothers, particularly for those whose first infants were born after 2003, with a hazard ratio of 0.87 indicating a 13% lower risk of a second pregnancy compared to controls.

The program was especially effective for mothers aged 18 years or younger, with a remarkable hazard ratio of 0.40 in rural areas, suggesting that younger mothers in these locations were significantly less likely to have a second pregnancy within two years of their first child's birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in pregnancy outcomes following statewide implementation of a prenatal home visitation program. Rubin, DM., O'Reilly, AL., Luan, X., et al.[2022]

In a study of 643 high-risk families, home visiting programs did not show significant differences in short- and long-term outcomes for mothers compared to control groups, indicating that the overall effectiveness may be limited.

However, maternal relationship security played a crucial role; mothers with high relationship anxiety but low avoidance benefited the most from home visiting, while those with high anxiety and avoidance experienced negative effects, suggesting the need for tailored approaches in home visiting services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maternal relationship security as a moderator of home visiting impacts on maternal psychosocial functioning. McFarlane, E., Burrell, L., Crowne, S., et al.[2021]

A survey of 42 MIECHV administrators revealed that while MIECHV leadership is strong in many states, there are significant weaknesses in data systems and financial support for coordinating home visiting services with other early childhood programs.

Stronger state leadership and shared goals across sectors were linked to better perceptions of coordination, highlighting the need for states to collaborate and learn from each other to improve their coordination efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of State Context in Promoting Service Coordination in Maternal, Infant, and Early Childhood Home Visiting Programs. West, A., Duggan, AK., Gruss, K., et al.[2021]

The adapted Parent And Caregiver Active Participation Toolkit (PACT) significantly improved parent participation in the SafeCare® home visitation program, as evidenced by higher engagement levels compared to a previous group of parents.

Home visitors reported greater fidelity in assigning homework to parents when using the PACT for SC, indicating that the toolkit not only enhanced participation but also supported the implementation of program activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent And Caregiver Active Participation Toolkit (PACT): Adaptation for a Home Visitation Program. Haine-Schlagel, R., Fettes, DL., Finn, N., et al.[2022]

Home-visitation programs for socially disadvantaged women and children can significantly improve maternal health behaviors, birth outcomes, and child development, while also reducing child abuse and hospital visits.

The most effective programs involved nurses who started visits during pregnancy, maintained frequent contact, and focused on addressing behavioral and psychosocial factors, particularly for families at higher risk due to poverty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can home visitation improve the health of women and children at environmental risk? Olds, DL., Kitzman, H.[2022]

Early childhood home visitation programs are effective in preventing child abuse and neglect, as supported by strong evidence from a systematic review conducted by the Task Force on Community Preventive Services.

However, there is insufficient evidence to determine the effectiveness of these programs in preventing other forms of violence, such as violence by visited children or intimate partner violence, indicating that more research is needed in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First reports evaluating the effectiveness of strategies for preventing violence: early childhood home visitation. Findings from the Task Force on Community Preventive Services. Hahn, RA., Bilukha, OO., Crosby, A., et al.[2016]

In a study involving 2,357 families from 21 Healthy Families America and 9 Nurse-Family Partnership sites in New Jersey, both programs showed high levels of family engagement, with 59% of HFA and 64% of NFP families receiving a high dose of services in the first 6 months.

Home visitor characteristics were the main factor influencing service receipt in HFA (87% of variation), while family characteristics were more significant for NFP (75% of variation), suggesting that tailored engagement strategies could enhance participation, especially for families with lower education and higher risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Multilevel Factors for Family Engagement in Home Visiting Across Two National Models. Latimore, AD., Burrell, L., Crowne, S., et al.[2018]

The randomized trial demonstrated that a home visitation model for at-risk women significantly improved their social support and access to services after an average of ten months.

Participants in the experimental group also experienced decreased psychological distress, highlighting the model's effectiveness in supporting families at risk of out-of-home placement for their newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home visitation services for at-risk pregnant and postpartum women: a randomized trial. Marcenko, MO., Spence, M.[2022]

In a study involving 413 mothers, the use of interactive software in the e-Parenting Program (ePP) improved working alliance ratings at 6 months compared to standard services, indicating better engagement with the program.

However, despite the software's good acceptability, there were no significant differences in child maltreatment or risk factors between the ePP and other conditions at either the 6 or 12-month follow-ups, suggesting limited efficacy in preventing maltreatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology to Augment Early Home Visitation for Child Maltreatment Prevention: A Pragmatic Randomized Trial. Ondersma, SJ., Martin, J., Fortson, B., et al.[2018]

The 'Dads Matter' program was successfully integrated into standard home visiting services, showing feasibility and acceptability in a pilot study with 24 families.

Preliminary results indicated that the program positively impacted various outcomes, including the quality of the mother-father relationship and fathers' involvement with their children, with effect sizes generally larger than those seen in previous home visitation studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting father involvement in early home visiting services for vulnerable families: Findings from a pilot study of "Dads matter". Guterman, NB., Bellamy, JL., Banman, A.[2019]

Citations

1. trhv.thrive.psu.edu trhv.thrive.psu.edu/

Take Root Home Visitation: Helping Our Youngest Military ... This program will help you build trust with families and promote their ongoing learning and well-being by making transparent, evidence-based, and collaborative ...

2. withpower.com withpower.com/trial/phase-maltreatment-child-7-2022-e0d9e

Home Visitation Program for New Parent Support Research shows that home visitation programs can improve health behaviors during pregnancy, enhance parent-child interactions, and reduce child abuse and ...

3. militaryfamilies.psu.edu militaryfamilies.psu.edu/resources/view/delivering-take-root-to-military-families-with-a-child-0-to-3-years-old-examining-feasibility-and-proof-of-concet/

Delivering Take Root to Military Families with a Child 0-to 3 ... Results indicate that executing the research protocol and implementing the program among military families with young children were feasible.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05236192

NCT05236192 | New Parent Support Program Evaluation This study is designed to examine the implementation and program effectiveness of TRHV compared to services as usual (SAU).

5. portal.nifa.usda.gov portal.nifa.usda.gov/web/crisprojectpages/1014403-army-new-parent-support-program-implementation-of-evidence-based-curriculum-project.html

Army New Parent Support Program Implementation ... Home visitors will document their implementation of the program along with associated outcomes. In addition to fidelity tracking, measures will be completed at ...

6. pdc100.org pdc100.org/Forms/9-Take-Root-Home-Visitation-Protective-Factors-Survey-Short-Form-eng.pdf

PFS SF TRHV FINAL - PDC100 The Take Root Home Visitation curriculum uses a 15-item version of the PFS that includes all four subscales. It does not include the Child Development Knowledge ...

7. trhv.thrive.psu.edu trhv.thrive.psu.edu/wp-content/uploads/2021/07/trhv_training-syllabus-schedule_202108.pdf

Take Root Home Visitation Training Syllabus The TRHV training will provide you with the knowledge and the skills needed to use the TRHV curriculum with your families. Training Length: 17.0 hours over ...