Infant Mental HealthIMH-HV RCTNCT03175796
Infant Mental Health-Home Visiting Randomized Controlled Trial
A study testing Infant Mental Health-Home Visiting in people with Infant Mental Health, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant Mental Health
- What is being tested?
- Infant Mental Health-Home Visiting
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2017to 17 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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:
- 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.
- 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:
- Improved child outcomes as reflected in strengthened child physical and behavioral health, development and school readiness, and reduced risk for child maltreatment.
- Improved parental outcomes including improved parent mental health, decreased child abuse potential, and enhanced positive parenting.
- Improved family environment including decrease in crime and family violence, enhance linkage to referrals and improve family economics and self-sufficiency.
- 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.
Read the 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.
- Conditions
- Infant Mental Health
- Being tested
- Infant Mental Health-Home Visiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant Mental Health-Home VisitingBehavioural
Behavioral intervention aimed to increase parental competencies and promote mental health and sensitive caregiving.
| Study group | Role | What they receive |
|---|---|---|
| IMH-HV Treatment Group | Experimental | 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. Receives: Behavioral: Infant Mental Health-Home Visiting |
| Treatment as Usual Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start12 Oct 2017
- Primary completion17 Aug 2020
- Study completion17 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infant Mental HealthStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Responsible party
- Principal investigator, Kate Rosenblum, University of Michigan
- Investigators
- Katherine Rosenblum, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175796
- Sponsor's protocol ID
- HUM00124224
- Acronym
- IMH-HV RCT
- Status last verified
- Nov 2021
- First submitted
- 17 May 2017
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jester JM, Stacks AM, Riggs JL, Brophy-Herb HE, Muzik M, Rosenblum K; Michigan Collaborative for Infant Mental Health Research. Improved mental health for women receiving infant mental health home visiting: a randomized controlled trial. Front Psychol. 2025 Oct 9;16:1597655. doi: 10.3389/fpsyg.2025.1597655. eCollection 2025.
PubMed 41143010Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.
PubMed 37146219Riggs 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.
PubMed 34698704
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infant Mental Health-Home Visiting Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03175796
- Acronym / sponsor ID
- IMH-HV RCT / HUM00124224
- Conditions
- Infant Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michigan Department of Health and Human Services
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 17 Aug 2020 (actual)
- Study completion
- 17 Aug 2020 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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:
- Improved child outcomes as reflected in strengthened child physical and behavioral health, development and school readiness, and reduced risk for child maltreatment.
- Improved parental outcomes including improved parent mental health, decreased child abuse potential, and enhanced positive parenting.
- Improved family environment including decrease in crime and family violence, enhance linkage to referrals and improve family economics and self-sufficiency.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| IMH-HV Treatment Group | Experimental | Behavioral: Infant Mental Health-Home VisitingInfant 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 as Usual Control Group | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infant Mental Health-Home VisitingBehavioral intervention aimed to increase parental competencies and promote mental health and sensitive caregiving. | Behavioural | IMH-HV Treatment Group |
Primary outcome
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).
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).
Patient Health Questionnaire (PHQ-9)
Time frame: 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)
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Derived from this study: PubMed 41143010Jester JM, Stacks AM, Riggs JL, Brophy-Herb HE, Muzik M, Rosenblum K; Michigan Collaborative for Infant Mental Health Research. Improved mental health for women receiving infant mental health home visiting: a randomized controlled trial. Front Psychol. 2025 Oct 9;16:1597655. doi: 10.3389/fpsyg.2025.1597655. eCollection 2025.
- Derived from this study: PubMed 37146219Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.
- Derived from this study: PubMed 34698704Riggs 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine Rosenblum, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infant Mental Health-Home Visiting in people with Infant Mental Health, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist (PCL-5) (time frame: 1 Year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03175796, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.