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Piloting a Precision Approach to Home Visiting

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ClinicalTrials.gov Identifier: NCT03975530
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
Inter-Tribal Council of Michigan, Inc.
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:

The proposed study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Sites in both groups will use an electronic platform to support implementation. The investigators will select four sites and randomize two of them to standard Family Spirit and two to precision Family Spirit. Sites will be matched based on annual volume of clients served and geographic similarity (i.e. urban vs. rural). All participating sites will be trained in the electronic implementation support platform. The two sites randomized to provide the precision approach will receive additional training on how to provide it.

In each site, all new clients who are prenatal or up to 2-months postpartum will be offered participation in the study. The study will then follow them until 12 months postpartum and measure outcomes during this time (see measurement table below). Qualitative interviews will be done at 6 and 12 months postpartum. Analysis of study instruments (basic psychometrics based on baseline and endline data) and preliminary differences between the sites on Aim 3 and 4 outcomes will be done in December 2019 assuming the investigators have achieved their estimated sample size with enough retention for 6-months post enrollment. Dissemination of results will be done upon completion of the analysis.


Condition or disease Intervention/treatment Phase
Parenting Mother-Child Relations Child Development Behavioral: Precision Family Spirit Behavioral: Standard Family Spirit Not Applicable

Detailed Description:

Home visiting programs provide critical support to families and young children to promote healthy development and reduce health disparities. Decades of research has yielded a robust evidence base supporting their effectiveness and impact on maternal and child outcomes. In 2010, the importance of these interventions was recognized nationally with the authorization of $1.5 billion to fund Maternal, Infant, and Early Childhood Home Visiting (MIECHV) across states and tribes. MIECHV was most recently reauthorized and funded for five years in early 2018. There are now 20 evidence-based early childhood home visiting models nationwide, all of which have evidence from multiple randomized controlled trials, favorable impacts on primary and secondary outcomes, and sustained impacts of the intervention over time.

Despite robust evidence of early childhood home-visiting effectiveness, replication and scale-up beyond the context of research has been challenging. Improving program retention, enhancing program content to address families' unique and often complex needs, and increasing fidelity have been identified as priority areas for further research. While building the evidence base for home-visiting programs, researchers necessarily took a "one-size-fits-all" approach - designing programs that are often lengthy (2-3 years long) and include standard lesson sequencing and dosing delivered in the same way to all participants. However, mothers and children do not all need the same program content or dosages. A one-size-fits-all approach fails to address maternal-child need and has led to differential outcomes across studies and populations, indicating that the promise of home-visiting to improve health has yet to be fully realized.

The need for home-visiting programs that can address maternal-child diverse and emergent needs and improve client reach and retention, while maintaining fidelity to the active ingredients of evidence-based home-visiting programs, is at the forefront of research and practice-based dialogue in the US. Recent qualitative research on high- and low-retention sites within the Nurse Family Partnership network showed that nurses in high retention sites were more collaborative with families and adapted the program to align more with families' needs compared to nurses in low retention sites. Based on these findings, Ingoldsby and colleagues used principals of motivational interviewing to provide nurses with more explicit control over the visit schedule and content to families. When they compared retention rates for nurses trained in motivational interviewing to rates for nurses trained in the standard approach, they found retention rates were significantly better when nurses had more flexibility in service delivery.

For the past two years, the Johns Hopkins Center for American Indian Health (CAIH) at Johns Hopkins University has partnered with the Annie E. Casey Foundation for formative work to develop a precision public health approach to the Family Spirit home-visiting program. Leveraging CAIH's existing evidence-based home-visiting program, Family Spirit, the goal of this project was to enhance the Family Spirit model to aid home visitors in tailoring content to meet families' specific needs and continuously monitor clients' emergent issues or improvements so that home-visiting education remains responsive, relevant, and feasible. This precision approach and corresponding implementation support have been developed. The current study will be a pilot study of the precision approach compared to the standard of care. In the standard of care, families receive regular home visits, delivered in the same sequence for up to 39 months. In the precision approach, there is a core set of lessons that every mother will get, but then additional lessons will be added based on maternal or child need. For example, if a mother is a first-time mom, they will get additional baby care lessons that are included in the standard Family Spirit curriculum but may not be relevant for moms with previous children.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Piloting a Precision Approach to Home Visiting
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Arm Intervention/treatment
Experimental: Precision Family Spirit
Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive a customized version of Family Spirit that is unique to your circumstances. The two sites randomized to provide the Precision approach will receive additional training on how to provide it. At 6 months postpartum, and upon completion of the intervention, participants in the treatment group will be asked to participate in brief semi-structured phone interviews.
Behavioral: Precision Family Spirit
Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive a customized version of Family Spirit that is unique to your circumstances. The two sites randomized to provide the Precision approach will receive additional training on how to provide it.

Active Comparator: Standard Family Spirit
Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive Family Spirit lessons based on a standard program schedule.
Behavioral: Standard Family Spirit
Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit.Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive Family Spirit lessons based on a standard program schedule.




Primary Outcome Measures :
  1. Acceptability of the home-visiting program from the perspective of mothers enrolled [ Time Frame: Baseline, 2-months postpartum, 6-months postpartum, 12-months postpartum ]

    We will use the acceptability subscale from the Applied Mental Health Research group's Implementation Measure:

    Haroz, E. E., Bolton, P., Nguyen, A. J., Lee, C., Bogdanov, S., Bass, J., ... & Murray, L. (2019). Measuring implementation in global mental health: validation of a pragmatic implementation science measure in eastern Ukraine using an experimental vignette design. BMC health services research, 19(1), 262.

    The acceptability subscale has 17 items and is scored as an average across items with a range of 0 being lowest acceptability to 3 being highest acceptability.


  2. Retention in the home-visiting programs [ Time Frame: 2-months postpartum, 6-months postpartum, 12-months postpartum ]
    We will compare the proportion of mothers who enroll and are still enrolled at the measurement timepoint across the study arms.

  3. Parenting self-efficacy [ Time Frame: Baseline, 2-months postpartum, 6-months postpartum, 12-months postpartum ]
    We will use a shortened version of the self-efficacy scale on the Parenting Locus of Control measure to comparing changes in parenting self-efficacy across the study arms. There are 9 items on the scale. The scale is scored as an average with possible scores ranging from 1 indicating low parenting self-efficacy to 5 indicating high parenting self-efficacy.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study participants will be pregnant or recent postpartum females aged 14 or older at time of conception of index pregnancy who are already enrolled in Family Spirit.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Prenatal or postpartum females who have a baby no older than 2 months old
  • At least 14 years of age at time of conception
  • Receiving Family Spirit services through ITC of MI

Exclusion Criteria:

  • < 13 years old at time of conception of index pregnancy
  • Index child is older than 2 months of age
  • Inability to participate in full intervention or evaluation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975530


Contacts
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Contact: Emily Haroz, PhD 410-955-6931 eharoz1@jhu.edu
Contact: Allison Ingalls, MPH 410-955-6931 aingalls@jhu.edu

Locations
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United States, Michigan
Inter-Tribal Council of Michigan (ITC of MI) Recruiting
Sault Sainte-Marie, Michigan, United States, 49783
Contact: Amanda Leonard    906-632-6896    Amanda@itcmi.org   
Contact: Elizabeth Kushman    906-632-6896    elizabeth@itcmi.org   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Inter-Tribal Council of Michigan, Inc.
Investigators
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Principal Investigator: Emily Haroz, PhD Johns Hopkins Bloomberg School of Public Health

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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT03975530     History of Changes
Other Study ID Numbers: 9315
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Home visiting interventions
American Indian
Community based participatory research
Pregnancy