Piloting a Precision Approach to Home Visiting

NCT03975530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-01-06

No results posted yet for this study

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 with precision participants will be done at 6 and 12 months postpartum. Focus group discussions with home visitors will also be completed during regular study team meetings. Analysis of study instruments (basic psychometrics based on baseline and end line 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.

Conditions

  • Parenting
  • Mother-Child Relations
  • Child Development

Interventions

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.

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.

Sponsors & Collaborators

  • Inter-Tribal Council of Michigan, Inc.

    collaborator UNKNOWN
  • Johns Hopkins Bloomberg School of Public Health

    lead OTHER

Principal Investigators

  • Emily Haroz, PhD · Johns Hopkins Bloomberg School of Public Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-24
Primary Completion
2020-12-18
Completion
2020-12-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03975530 on ClinicalTrials.gov