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

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.

Study Overview

• Status: Completed
• Conditions: Infant Mental Health
• Intervention / Treatment: Behavioral: Infant Mental Health-Home Visiting

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 Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IMH-HV Treatment Group; 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.	Behavioral: Infant Mental Health-Home Visiting; Behavioral intervention aimed to increase parental competencies and promote mental health and sensitive caregiving.
No Intervention: Treatment as Usual Control Group; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Michigan Department of Health and Human Services
• Investigators: Principal Investigator: Katherine Rosenblum, PhD, University of Michigan

Publications and helpful links

General Publications

• Riggs JL, Rosenblum KL, Muzik M, Jester J, Freeman S, Huth-Bocks A, Waddell R, Alfafara E, Miller A, Lawler J, Erickson N, Weatherston D, Shah P, Brophy-Herb H; Michigan Collaborative for Infant Mental Health Research. Infant Mental Health Home Visiting Mitigates Impact of Maternal Adverse Childhood Experiences on Toddler Language Competence: A Randomized Controlled Trial. J Dev Behav Pediatr. 2022 May 1;43(4):e227-e236. doi: 10.1097/DBP.0000000000001020. Epub 2021 Oct 25.

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Actual): August 17, 2020
• Study Completion (Actual): August 17, 2020

Study Registration Dates

• First Submitted: May 17, 2017
• First Submitted That Met QC Criteria: June 1, 2017
• First Posted (Actual): June 5, 2017

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 12, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HUM00124224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No