Infant Mental Health-Home Visiting Randomized Controlled Trial

Not Applicable

Completed

• Conditions: Infant Mental Health
• Interventions: Behavioral: Infant Mental Health-Home Visiting

• Registration Number: NCT03175796
• Lead Sponsor: University of Michigan

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-06-01
• Study First Posted: 2017-06-05
• Study Start: 2017-10-12
• Primary Completion: 2020-08-17
• Study Completion: 2020-08-17
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-12
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMH-HV Treatment Group	Infant Mental Health-Home Visiting	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.

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder (GAD-7)	1 Year	Change in caregiver anxiety via measurement on GAD-7 with a range of 0 (no symptoms) to 21 (high level of anxiety symptoms endorsed).
Infant Toddler Social-Emotional Assessment (ITSEA)	1 Year	Change in caregiver reported social-emotional behavior problems of child via measurement on ITSEA using t-scores derived from ITSEA-provided standard norms
PTSD Checklist (PCL-5)	1 Year	Change in caregiver PTSD symptoms via measurement on PCL-5 with a range of 0 (no symptoms) to 80 (high level symptom endorsement).
Patient Health Questionnaire (PHQ-9)	2 years	Change in caregiver self-reported depression via measurement on PHQ-9 with a range of 0 (no depression symptoms) to 27 (high level of depression symptoms endorsed).
Brief Child Abuse Potential Inventory (BCAP)	1 Year	Change in caregiver self-reported emotional distress, rigidity, social isolation (risks associated with child maltreatment) via measurement on BCAP with a range of 0-24.
Working Model of the Child Interview (WMCI)	1 year	Categorization of caregiver perception of child and relationship with child that moves from distorted or disengaged to balanced via measurement on the WMCI.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States