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NCT03175796 · ClinicalTrials.gov registry record · NA
Infant Mental Health-Home Visiting Randomized Controlled Trial
A NA study of Infant Mental Health, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 148
- Enrollment target
- 1
- Study location
NCT03175796: Completed NA study of Infant Mental Health, sponsored by University of Michigan.
NCT03175796 is a NA study of Infant Mental Health that has completed, run by University of Michigan. The registered enrollment target is 148 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03175796, a NA study of Infant Mental Health, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 148 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective is to rigorously evaluate the effectiveness of the Infant Mental Health Home Visiting (IMH-HV) model on maternal and child outcomes according to legislative standards via a randomized controlled trial. The research team will recruit caregivers and their children (0-24 months) or pregnant women (n=72) from locations across Washtenaw County to participate in the IMH-HV RCT. Half of the women will be randomly assigned to a treatment as usual (TAU) control group (with access to all available community resources), and half of the women will be randomly assigned to the treatment group (i.e., IMH-HV). Women assigned to the control group will not receive IMH-HV treatment through the study team, but will not be prohibited from seeking or accessing IMH-HV treatment or any other services through community resources. Women assigned to the treatment group will receive IMH-HV treatment for 12 months through the study team with rigorous monitoring of fidelity to the IMH-HV model. All study participants will undergo assessments across the 24-month period (12 months of which are the treatment trial) (i.e., baseline (randomization will occur after baseline), mid-points (3, 6 and 9 months) and follow-ups (12, 18 and 24 months) after randomization). Additionally, all study participants will have the opportunity to participate in assessments regarding their experience of the COVID-19 pandemic. The purpose of this study is to evaluate efficacy of the Infant Mental Health Home-Visiting (IMH-HV) model on parental and child outcomes according to legislative standards and consistent with the State of Michigan's benchmarks. If this study confirms the efficacy of the IMH-HV model, this will support the sustainability of IMH-HV in the state of Michigan as evidence from a randomized controlled trial is necessary in order to access certain state and federal dollars. Access to evidence-based and sustainable parenting support can ultimately improve outcomes for this vulnerabl
Primary Outcome
Change in caregiver PTSD symptoms via measurement on PCL-5 with a range of 0 (no symptoms) to 80 (high level symptom endorsement).
Conditions Studied
Interventions
- BEHAVIORAL Infant Mental Health-Home Visiting
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 148 participants |
| Start Date | 2017-10-12 |
| Est. Completion | 2020-08-17 |
| Phase | NA |
What the finished NCT03175796 record still lists
NCT03175796 is an interventional study that assigns participants to a tested intervention. The registered 148 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Infant Mental Health appearing as the primary indexed condition, and to 1 intervention - of which Infant Mental Health-Home Visiting is the first listed.
NCT03175796 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03175796 about?
NCT03175796 is a clinical study titled "Infant Mental Health-Home Visiting Randomized Controlled Trial". The primary objective is to rigorously evaluate the effectiveness of the Infant Mental Health Home Visiting (IMH-HV) model on maternal and child outcomes according to legislative standards via a randomized controlled trial. The research team will recruit caregivers and their children (0-24 months) o...
What is the current status of trial NCT03175796?
This trial is currently completed. It is a NA study. The enrollment target is 148 participants. The study started on 2017-10-12. Estimated completion is 2020-08-17.
What conditions does trial NCT03175796 study?
This clinical trial studies the following conditions: Infant Mental Health.
What interventions are being tested in trial NCT03175796?
The interventions under investigation include: Infant Mental Health-Home Visiting (BEHAVIORAL).
Who is sponsoring clinical trial NCT03175796?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03175796 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03175796's enrollment target sits among peer trials
148 702nd of 2000 higher than 1,298 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
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