Clinical trial NCT05236192: New Parent Support Program Evaluation
Official title: Navy and Marine Corps New Parent Support Program Evaluation
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Child Maltreatment
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: United States Department of Agriculture (USDA)
First posted: 2022-02-11
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A cluster randomized control trial effectiveness-implementation hybrid type 2 design will be used. Navy and Marine Corps installations participating in this study will be randomly assigned to one of two conditions: TRHV and SAU. Families receiving NPSP home visiting services will be administered TRHV or SAU depending upon the assignment of their installation.
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to perform a program evaluation of the Navy and Marine Corps' New Parent Support Program (NPSP) home-visiting option. Both the Navy and Marine Corps have decided to pilot the Take Root Home Visitation (TRHV) curriculum, which is an evidence-informed, standardized program, with clients receiving NPSP home visits. This study is designed to examine the implementation and program effectiveness of TRHV compared to services as usual (SAU). Program outcomes include child development, parenting behaviors, child maltreatment risk and protective factors, and child maltreatment incidents. Implementation outcomes include clinicians' and clients' satisfaction with the program, clinicians' fidelity to the program delivery model, and clients' engagement with the program.

Detailed description: The Navy and Marine Corps' NPSP home visiting option assists families who are at risk for child abuse and neglect by providing those families with home visitation by a trained professional (e.g., licensed clinical social worker, nurse). The ultimate goal of NPSP home visiting is to promote strong parenting practices and healthy families by providing parents with skills to foster child development and well-being. Families, expecting a child and with children up to age three, participating in the NPSP home visiting services at select military installations will be recruited for a cluster randomized controlled effectiveness-implementation hybrid Type 2 design program evaluation, which simultaneously tests the implementation and client related outcomes of a program (Curran et al., 2012).

Rigorous program evaluations of Navy and Marine Corps NPSP home visiting services are lacking. In fact, only one published study evaluating Navy NPSP could be located (Kelley et al., 2006). While the results of Kelley et al.'s (2006) study were generally positive, it was a single-group retrospective design that did not assess implementation outcomes or program outcomes related to child maltreatment. Thus, that study's ability to inform NPSP home visiting services is limited. Further, findings from past analyses of Army NPSP offered no evidence that NPSP services directly prevent child abuse and neglect (Kaye, Faber, Schiavone, \& Perkins, 2016). Among the general U.S. population, research findings are mixed with regard to the effectiveness of home visiting programs for preventing child maltreatment (Howard \& Brooks-Gunn, 2009; Kaminski, Valle, Filene, \& Boyle, 2008). However, the available evidence does indicate that these programs can positively alter parenting practices.

Without a rigorous, experimental evaluation, it is difficult to assess whether the Navy's and Marine Corps' NPSP service as usual (SAU) is having the intended impacts on participating families. Further, the both Services are interested in exploring the utility of delivering the Take Root Home Visitation (TRHV) program. TRHV is a newly developed, evidence-informed, secondary, home-visiting prevention program developed by researchers at the Clearinghouse for Military Family Readiness at Penn State in collaboration with the Office of the Deputy Assistant Secretary of Defense for Military Community and Family Policy. TRHV has not been evaluated within the context of the Navy or Marine Corps. TRHV has been implemented with the Army as part of the Clearinghouse's three-phase evaluation of Army NPSP. Though the final report is still forthcoming, a preliminary report on program implementation showed that home visitors found TRHV to be acceptable and were able to implement the program with fidelity (Kaye et al., 2021). Moreover, parents receiving TRHV reported high levels of satisfaction with the program and stayed in NPSP services longer than parents receiving SAU (Kaye et al., 2021).

The extent to which the Army TRHV implementation findings generalize to the Navy and Marine Corps is unclear. Additionally, it is unclear to what extent TRHV will impact program outcomes, especially when compared to SAU. This study is designed to help bring clarity to these issues.

Eligibility criteria: Inclusion Criteria (NPSP Participants):

* 18+ years old
* Stationed at one of the participating military installations
* Active duty, retired, National Guard or Reserves service member or spouse/partner
* Pregnant or have a child 0-3-years-old
* Eligible to receive NPSP home-visiting services
* Speak and understand English proficiently

Inclusion Criteria (NPSP Home Visitors):

* 18+ years old
* Working at one of the participating military installations as a NPSP home visitor
* Speak and understand English proficiently

Inclusion Criteria (NPSP Participants' Children):

* Children of active duty, retired, National Guard or Reserves service member or spouse/partner receiving NPSP home-visiting services
* 0-3-years-old

Exclusion Criteria (NPSP Participants):

* Younger than 18 years of age
* Not stationed at one of the participating military installations
* Not an active duty, retired, National Guard or Reserves service member or spouse/partner
* Not currently pregnant or the parent of a child 0-3-years-old
* Not eligible for NPSP home-visiting services
* Does not speak or understand English proficiently

Exclusion Criteria (NPSP Home Visitors):

* Younger than 18 years of age
* Not employed at one of the participating military installations as a NPSP home visitor
* Does not speak or understand English proficiently

Exclusion Criteria (NPSP Participants' Children):

* Not the child of an active duty, retired, National Guard or Reserves service member or spouse/partner receiving NPSP home-visiting services
* Older than 3 years of age

Primary outcomes:
measure: Change in Brief Child Abuse Potential Inventory (BCAP)
timeFrame: Baseline, 3-4 months post-baseline, 6-7 months post-baseline, and NPSP service or study completion (whichever occurs first - study completion is approximately 12 months post-baseline)
measure: Child Maltreatment Incident Report
timeFrame: Study completion, which is approximately 12 months post-baseline
measure: Change in Ages & Stages Questionnaire, Third Edition (ASQ-3)
timeFrame: Baseline, 3-4 months post-baseline, 6-7 months post-baseline, and NPSP service or study completion (whichever occurs first - study completion is approximately 12 months post-baseline)
measure: Change in Parenting Skills Assessment 10th Edition (PSA-10)
timeFrame: Baseline, 6-7 months post-baseline, and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)
measure: Change in Family Needs Screener (FNS)
timeFrame: Baseline, 6-7 months post-baseline, and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)
measure: Change in Protective Factors Survey (PFS)
timeFrame: Baseline, 6-7 months post-baseline, and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)
measure: Change in Parental Stress Scale (PSS)
timeFrame: Baseline, 3-4 months post-baseline, 6-7 months post-baseline, and NPSP service or study completion (whichever occurs first - study completion is approximately 12 months post-baseline)
measure: Change in Center for Epidemiological Studies Depression Scale (CESD-10)
timeFrame: Baseline, 6-7 months post-baseline, and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: 6-7 months post-baseline and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)
measure: Client Engagement Survey (CES)
timeFrame: 3-4 months post-baseline, 6-7 months post-baseline, and NPSP service or study completion (whichever occurs first - study completion is approximately 12 months post-baseline)
measure: Evidence-Based Practice Attitude Scale (EBPAS)
timeFrame: Baseline
measure: Treatment Fidelity
timeFrame: Baseline, 3-4 months post-baseline, 6-7 months post-baseline, and NPSP service or study completion (whichever occurs first - study completion is approximately 12 months post-baseline)
Secondary outcomes:
measure: Program Reach
timeFrame: Study completion, which is approximately 12 months post-baseline
measure: Program Penetration
timeFrame: Study completion, which is approximately 12 months post-baseline
Other outcomes:
Locations:
city: University Park
country: United States
facility: The Pennsylvania State University
state: Pennsylvania
Study officials:
affiliation: The Pennsylvania State University
name: Ryan P Chesnut, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Pennsylvania State University
name: Daniel F Perkins, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
citation: Kelley, M. L., Schwerin, M. J., Farrar, K. L., & Lane, M. E. (2006). A participant evaluation of the U.S. Navy parent support program. Journal of Family Violence, 21, 301-310. https://doi.org/10.1007/s10896-006-9031-5
citation: Kaye, M. P., Faber, A., Schiavone, W., & Perkins, D. F. (2016). New Parent Support Program Engagement Phase II Final Report. University Park, PA: Clearinghouse for Military Family Readiness at Penn State.
citation: Kaye, M. P., Ferrara, A. M., Abram-Erby, G., Kotch, R., Gernon, S., & Perkins, D. F. (2021, April). Take Root Home Visitation implementation: Army New Parent Support Program (NPSP) EIII. University Park, PA: Clearinghouse for Military Family Readiness at Penn State.
citation: Kaminski JW, Valle LA, Filene JH, Boyle CL. A meta-analytic review of components associated with parent training program effectiveness. J Abnorm Child Psychol. 2008 May;36(4):567-89. doi: 10.1007/s10802-007-9201-9. Epub 2008 Jan 19.
citation: Howard KS, Brooks-Gunn J. The role of home-visiting programs in preventing child abuse and neglect. Future Child. 2009 Fall;19(2):119-46. doi: 10.1353/foc.0.0032.