NCT05236192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

February 17, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2025

Completed
Last Updated

October 8, 2025

Status Verified

January 1, 2025

Enrollment Period

2.5 years

First QC Date

February 2, 2022

Last Update Submit

October 6, 2025

Conditions

Outcome Measures

Primary Outcomes (12)

  • Change in Brief Child Abuse Potential Inventory (BCAP)

    The BCAP is the short form of the Child Abuse Potential Inventory (CAPI), which assesses potential risk for child abuse. Scores range from 0-24 with higher scores indicating greater risk.

    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)

  • Child Maltreatment Incident Report

    Administrative data will be collected to determine if a child maltreatment incident has occurred.

    Study completion, which is approximately 12 months post-baseline

  • Change in Ages & Stages Questionnaire, Third Edition (ASQ-3)

    ASQ-3 is a standardized measure of child development across five domains: communication, gross motor, fine motor, problem-solving, and personal-social. Questionnaires are based on child age (and prematurity status). Scores range from 0-60 within each domain with higher scores reflecting typical development. Raw scores within each domain are classified into typical development, monitoring, and referral categories based upon established cut-off criteria.

    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)

  • Change in Parenting Skills Assessment 10th Edition (PSA-10)

    PSA-10 is an observational tool designed to measure parenting skills across five domains: communication with child, child management and supervision, parent/child activities, nurturing, and enriched environment. Domain scores range from 5 to 20 with higher scores indicating greater competence in that skill area.

    Baseline, 6-7 months post-baseline, and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)

  • Change in Family Needs Screener (FNS)

    FNS is a family violence risk screener that assess 10 factors: demographics, stress, relationship discord, support, substance abuse, violence approval, family of origin violence and neglect, self-esteem, depression, and prior family violence. Scores for item scale item are dichotomized and summed such that total scores range from 0 to 53 with a score of 9 or higher being classified as high needs.

    Baseline, 6-7 months post-baseline, and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)

  • Change in Protective Factors Survey (PFS)

    PFS assesses the presence of factors known to buffer against child maltreatment, such as family functioning, emotional support, concrete support, and nurturing and attachment. Subscale scores range from 1 to 7 with higher scores reflecting greater protection.

    Baseline, 6-7 months post-baseline, and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)

  • Change in Parental Stress Scale (PSS)

    PSS assesses four aspects of parenting stress: parental rewards, parental stressors, lack of control, and parental satisfaction. Subscale scores can be computed, but most often, a total score, ranging from 18 (low stress) to 90 (high stress), is calculated.

    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)

  • Change in Center for Epidemiological Studies Depression Scale (CESD-10)

    CESD-10 is a brief measure that assesses depressive symptoms over the prior week. Scores range from 0 to 30, with higher scores indicating greater depression.

    Baseline, 6-7 months post-baseline, and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)

  • Client Satisfaction Questionnaire (CSQ-8)

    CSQ-8 measures clients' satisfaction with the services they have received. Scores range from 8 to 32 with higher scores reflecting greater satisfaction.

    6-7 months post-baseline and NPSP service or study completion completion (whichever occurs first - study completion is approximately 12 months post-baseline)

  • Client Engagement Survey (CES)

    CES is a measure of clients' engagement with the services they are receiving. Four domains of engagement are assessed: receptivity (score range: 4 to 20), buy-in (score range: 9 to 40), working relationship (score range: 4 to 20), and mistrust (score range: 3 to 15). The total engagement score ranges from 20 to 95 with higher scores reflecting greater engagement.

    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)

  • Evidence-Based Practice Attitude Scale (EBPAS)

    EBPAS assesses providers' attitudes regarding the adoption of new treatments, interventions, and practices. Four domains are measured: requirements, appeal, openness, and divergence. Subscale scores and the total score are calculated by averaging the appropriate items, so scores range from 0 to 4 with higher scores indicating more of the construct of interest.

    Baseline

  • Treatment Fidelity

    Brief checklists will be used to assess NPSP home visitors' adherence to the program model.

    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 (2)

  • Program Reach

    Study completion, which is approximately 12 months post-baseline

  • Program Penetration

    Study completion, which is approximately 12 months post-baseline

Study Arms (2)

Take Root Home Visitation (TRHV)

EXPERIMENTAL

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

Behavioral: Take Root Home Visitation (TRHV)

Services as Usual (SAU)

ACTIVE COMPARATOR

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

Behavioral: Services as Usual (SAU)

Interventions

TRHV is a home-visiting, standardized program that home visitors can use to structure their time spent with families during home visits.

Take Root Home Visitation (TRHV)

SAU includes an installation's current NPSP home visiting practice, which may vary across the installations participating in this study.

Services as Usual (SAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + 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
  • + years old
  • Working at one of the participating military installations as a NPSP home visitor
  • Speak and understand English proficiently
  • Children of active duty, retired, National Guard or Reserves service member or spouse/partner receiving NPSP home-visiting services
  • years-old

You may not qualify if:

  • 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
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (6)

  • 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.

    PMID: 22310560BACKGROUND
  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 18205039BACKGROUND
  • 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.

    PMID: 19719025BACKGROUND

Study Officials

  • Ryan P Chesnut, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR
  • Daniel F Perkins, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Research Professor

Study Record Dates

First Submitted

February 2, 2022

First Posted

February 11, 2022

Study Start

February 17, 2023

Primary Completion

August 7, 2025

Study Completion

August 7, 2025

Last Updated

October 8, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations