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

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ClinicalTrials.gov Identifier: NCT03175796
Recruitment Status : Recruiting
First Posted : June 5, 2017
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 12-month period of the treatment trial (i.e., baseline (randomization will occur after baseline), mid-points (3, 6 and 9 months) and follow-up (12 months) after randomization).

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.

Condition or disease Intervention/treatment
Infant Mental Health 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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Infant Mental Health-Home Visiting Randomized Controlled Trial
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : April 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. PTSD Checklist (PCL-5) [ Time Frame: 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).

  2. Generalized Anxiety Disorder (GAD-7) [ Time Frame: 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).

  3. Patient Health Questionnaire (PHQ-9) [ Time Frame: 1 Year ]
    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).

  4. Brief Child Abuse Potential Inventory (BCAP) [ Time Frame: 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.

  5. Working Model of the Child Interview (WMCI) [ Time Frame: 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.

  6. Infant Toddler Social-Emotional Assessment (ITSEA) [ Time Frame: 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Mothers that are primary, permanent caregivers of a child 0-24 months (male or female) OR 29+ weeks pregnant
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175796


Contacts
Contact: Rachel Waddell, MSW (734) 998-0089 rhenson@med.umich.edu
Contact: Emily Alfafara, BA (734) 998-8145 emalfafa@med.umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Emily Alfafara    734-998-8145    thrivingtogether@umich.edu   
Sponsors and Collaborators
University of Michigan
Michigan Department of Health and Human Services
Investigators
Principal Investigator: Katherine Rosenblum, PhD University of Michigan
More Information

Responsible Party: Kate Rosenblum, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT03175796     History of Changes
Other Study ID Numbers: HUM00124224
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No