NCT03975530

Piloting a Precision Approach to Home Visiting

Completed NA Last updated 6 January 2022

What this trial tests

NA trial testing Precision Family Spirit in Parenting in 66 participants. Completed in 18 December 2020.

Timeline

24 June 2019

Primary endpoint
18 December 2020

18 December 2020

Quick facts

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	66
Start date	24 June 2019
Primary completion	18 December 2020
Estimated completion	18 December 2020
Sites	1 location across United States

Drugs / interventions tested

• Precision Family Spirit
• Standard Family Spirit

Conditions studied

• Parenting — all drugs for Parenting →
• Mother-Child Relations — all drugs for Mother-Child Relations →
• Child Development — all drugs for Child Development →

Sponsor

Johns Hopkins Bloomberg School of Public Health

Who can join

14 and older, female only, with Parenting or Mother-Child Relations. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Utilizing broad-based partnerships to design a precision approach to implementing evidence-based home visiting.
   Haroz EE, Ingalls A, Wadlin J, Kee C, et al · · 2020 · cited 11× · PMID 31970805 · DOI 10.1002/jcop.22281
2. Precision Family Spirit: a pilot randomized implementation trial of a precision home visiting approach with families in Michigan-trial rationale and study protocol.
   Ingalls A, Barlow A, Kushman E, Leonard A, et al · · 2021 · cited 8× · PMID 33407939 · DOI 10.1186/s40814-020-00753-4
3. Towards precision home visiting: results at six months postpartum from a randomized pilot implementation trial to assess the feasibility of a precision approach to Family Spirit.
   Ingalls A, Rebman P, Martin L, Kushman E, et al · · 2022 · cited 5× · PMID 36151535 · DOI 10.1186/s12884-022-05057-4
4. Towards Precision Home Visiting: Results at Six Months Postpartum from a Randomized Pilot Implementation Trial to Assess the Feasibility of a Precision Approach to Family Spirit
   Ingalls A, Rebman P, Martin L, Kushman E, et al · · 2022 · DOI 10.21203/rs.3.rs-1620081/v1