Clinical Trial 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 vulnerable population. Specifically this study aims to:
1. Conduct a randomized controlled trial to evaluate the efficacy of IMH-HV treatment
utilizing rigorous outcomes monitoring and evaluation methodology to establish that the
families served achieve the intended positive benefit. Eligible caregivers and children
or pregnant women will be assigned to the control group or the treatment group and both
groups will receive research assessments at regular intervals measuring key impacts of
the IMH-HV model.
2. Determine IMH-HV efficacy via analysis of treatment impact on key caregiver, child, and
family indicators. The hypothesis is that there will be positive impacts of IMH-HV, with
caregiver, child, and family-level improvements from baseline to post assessment on key
indicators, including:
1. Improved child outcomes as reflected in strengthened child physical and behavioral
health, development and school readiness, and reduced risk for child maltreatment.
2. Improved parental outcomes including improved parent mental health, decreased child
abuse potential, and enhanced positive parenting.
3. Improved family environment including decrease in crime and family violence,
enhance linkage to referrals and improve family economics and self-sufficiency.
3. Identify factors associated with family improvement, including dosage and fidelity of
treatment. It is the hypothesis that a dose-response association between the number of
home visiting sessions and treatment impact, and a positive association between fidelity
of treatment delivered and positive child and family outcomes.
A small number of inclusion/exclusion criteria have not been disclosed in this record to
preserve scientific integrity. They will be added to make this record complete once all study
data is collected.
