Piloting a Precision Approach to Home Visiting

Completed · Not applicable

Conditions studied: Parenting, Mother-Child Relations, Child Development

In brief

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.

Key facts

Study ID

NCT03975530

Run by

Johns Hopkins Bloomberg School of Public Health

People needed

66

Starts

2019-06-24

Expected to finish

2020-12-18

Last updated by the study team

2022-01-06

Who can join

Age: 14 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• < 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

Where it is running

• Inter-Tribal Council of Michigan (ITC of MI) — Sault Ste. Marie, Michigan, United States

Full record on ClinicalTrials.gov

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