Infant Mental Health-Home Visiting Randomized Controlled Trial (IMH-HV RCT)

University of Michigan

Status: Completed

Conditions: Infant Mental Health

Treatments: Behavioral: Infant Mental Health-Home Visiting

Study type: Interventional

Funder types: Other

Identifiers

NCT03175796

HUM00124224

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 148 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Mothers (biological or adoptive) who:

• are the permanent, primary caregiver of a child between the ages of 0-24 months old or 29+ weeks pregnant;
• are at least 18 years of age;
• who speak and understand English; and,
• who meet specified criteria for: childhood experiences, depression, challenges with child, and socio-economic status.

Exclusion criteria

• Women who live farther than 20 miles away from Ann Arbor
• Women who are already enrolled in Infant Mental Health-Home Visiting services
• Women who meet criteria for alcohol/substance use disorders, or who screen positive for psychosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

IMH-HV Treatment Group

Experimental group

Description:

Infant Mental Health-Home Visiting. Weekly home visits for up to one year by a trained IMH-HV treatment provider. Treatment delivery consistent with the IMH-HV manual.

Treatment:

Behavioral: Infant Mental Health-Home Visiting

Treatment as Usual Control Group

No Intervention group

Description:

No intervention provided as part of participation in this study; families are free to access community resources including any available treatment(s) in the community.