Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03975530 · ClinicalTrials.gov registry record · NA
Piloting a Precision Approach to Home Visiting
A NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Completed
- Registry status
- NA
- Development phase
- 66
- Enrollment target
NCT03975530: Completed NA study, sponsored by Johns Hopkins Bloomberg School of Public Health.
NCT03975530 is a NA study that has completed, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 66 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03975530, a NA study, has completed, sponsored by Johns Hopkins Bloomberg School of Public Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 66 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- BEHAVIORAL Precision Family Spirit
- BEHAVIORAL Standard Family Spirit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2020-12-18 |
| Phase | NA |
What the finished NCT03975530 record still lists
NCT03975530 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Precision Family Spirit is the first listed.
NCT03975530 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03975530 about?
NCT03975530 is a clinical study titled "Piloting a Precision Approach to Home Visiting". 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 grou...
What is the current status of trial NCT03975530?
This trial is currently completed. It is a NA study. The enrollment target is 66 participants. The study started on 2019-06-24. Estimated completion is 2020-12-18.
What interventions are being tested in trial NCT03975530?
The interventions under investigation include: Precision Family Spirit (BEHAVIORAL), Standard Family Spirit (BEHAVIORAL).
Who is sponsoring clinical trial NCT03975530?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03975530's enrollment target sits among peer trials
66 1139th of 2000 higher than 857 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02584244 · 66 participants · Phase 1
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers
- NCT03067051 · 66 participants · Phase 1
Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
- NCT03754725 · 66 participants · Phase 1
Ferritin and Iron Burden in SAH sIRB
- NCT03875378 · 66 participants · Phase 2
Transdermal Estrogen in Women With Anorexia Nervosa
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI