Clinical trial NCT03175796: Infant Mental Health-Home Visiting Randomized Controlled Trial
Official title: Infant Mental Health-Home Visiting Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Mental Health
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Michigan Department of Health and Human Services
First posted: 2017-06-05
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: IMH-HV is a relationship-focused mental health intervention that aims to improve caregiver and child outcomes, including: improved caregiver mental health; enhanced positive parenting; decreased risk for physical/emotional neglect and/or abuse; and reduced risk for negative child outcomes including impaired development, cognitive delay and behavioral problems. In addition, IMH-HV services aim to reduce the probability of intergenerational transmission of the effects of unresolved loss and trauma in parents.

The IMH-HV Model uses a range of strategies for intervention, such as:

* attending to the health and basic material needs of the infant/toddler, parent(s), and family members;
* providing developmental guidance for positive parenting behavior;
* providing counseling/emotional support for the parents;
* developing parents' life coping skills and social support; and
* providing infant/parent psychotherapy.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: PTSD Checklist (PCL-5)
timeFrame: 1 Year
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: 1 Year
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 2 years
measure: Brief Child Abuse Potential Inventory (BCAP)
timeFrame: 1 Year
measure: Working Model of the Child Interview (WMCI)
timeFrame: 1 year
measure: Infant Toddler Social-Emotional Assessment (ITSEA)
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Katherine Rosenblum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.