Mother and Infant Home Visiting Program Evaluation

Pregnancy Clinical Trial

— MIHOPE  

Official title:

Mother and Infant Home Visiting Program Evaluation (MIHOPE

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02069782
• Other study ID #: HHSP23320095644 WC
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2012
• Est. completion date: September 2025

Study information

• Verified date: November 2023
• Source: MDRC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

MIHOPE is a multi-state study of home visiting programs authorized under the Maternal, Infant, and Early Childhood Home Visiting (MIECHV) program. The study is required by the federal Patient Protection and Affordable Care Act of 2010 (ACA), which created the MIECHV program. It is being conducted by MDRC under contract to the Administration for Children and Families within the US Department of Health and Human Services. In conducting the research, MDRC has subcontracted portions of the research to Mathematica Policy Research, Johns Hopkins University, Columbia University, University of Georgia, and James Bell Associates.

MIHOPE is randomly assigned 4,229 families nationally to home visiting services or to a comparison group that will receive referrals to other services in the community. The study is seeking to include 88 local home visiting programs (sites) that are funded through MIECHV in approximately 12 states. Data will be collected from families, local home visiting programs, and state and federal administrative data systems to assess the effects of the programs on family outcomes and to learn more about how the programs are run. Sites included in the evaluation will be using one of four national service models (Nurse Family Partnership, Healthy Families America, Parents as Teachers, and Early Head Start-Home Visiting Option) that states have chosen for most of their MIECHV funding. MIHOPE will inform the federal government about the effectiveness of the MIECHV program in its first few years of operation, and it will provide information to help states develop and strengthen home visiting programs in the future. Research findings will be disseminated through a report to Congress in 2015; reports on program impacts, implementation, and on the relationship between program features and program impacts; journal articles; and practitioner briefs.

Description:

MIHOPE includes two groups of participants. First, the included 4,229 women across 88 local home visiting programs (sites) in 12 states. Women will be randomized so that half can receive home visiting services and half are in a control group that receives referrals to other services in the community. Local home visiting programs chosen for the study must meet the following criteria: (1) they have been in operation for at least two years, (2) they are receiving funds through the MIECHV program, (3) they are operating one of the four evidence-based models described earlier, and (4) there is enough need for the program's services that they can provide a control group without reducing the number of families that receive home visiting.

Families were recruited as follows. Mothers were identified as eligible for a local home visiting program by staff from that program, using the program's current procedures. If the mother appears to be eligible for MIHOPE (based on the mother's age and pregnancy status or child's age), the home visiting staff will mention that a study is going on and that someone from the study team would like to be in touch to explain the study and to see if the mother is interested in participating. The home visiting program entered the mother's address and phone number. In addition, the home visiting program provided Mathematica with the mother's name and date of birth and the child's date of birth for purposes of making sure the family is not already in the study or has not previously declined to participate in the study. The MDRC Institutional Review Board determined that a partial authorization of the HIPAA Authorization requirement was warranted for use of the mother's information for sample recruitment.

Study field staff attempted to contact the family and schedule a visit to explain the study, request their participation, and obtain informed consent for research activities. Potential study participants were asked to sign two consent forms at the beginning of the study: one to participate in the study and to allow the team to collect administrative and survey data, and a second to be video-recorded during two home visits, if assigned to the home visiting group. Mothers also provided consent to allow us to collect information from the home visiting programs about the services they receive and information from the government on various information, including Medicaid records, vital records, child welfare records, and employment and earnings information from the National Database of New Hires. If an applicant was a non-emancipated minor, assent was obtained from the minor and written consent was obtained from her parent or guardian if the parent or guardian was in the home at the time of the recruitment visit. If the parent or guardian was not in the home, verbal consent was obtained. If verbal consent was provided, the parent or guardian was mailed a copy of the assent form that the woman signed and that explains what the research entails.

After consent was provided, study staff in the family's home initiated a call to the study's survey operations center for purposes of administering a one-hour survey. The family baseline survey included information on several domains specified in the ACA: newborn health; parental health and well-being; parenting practices, attitudes, and beliefs; domestic violence; history with the criminal justice system; family economic self-sufficiency; and referral and coordination of social services. In addition, the baseline survey collected information on demographics and household composition to describe the study sample, and contact information for family members or friends who can help locate the family at follow-up if they move. The survey also contained information about the parent's expectations regarding the home visiting program, which will inform research on program implementation. While the mother was completing the baseline survey by phone, the study field staff conducted the Home Observation for Measuring the Environment (HOME) to assess the quality and amount of stimulation that the child receives in the home as well as observations of the home environment. At the end of the telephone survey, the interviewer determined whether the family was assigned to the program (home visiting program) or control group (comparison group that will receive referrals to other services in the community); the result of random assignment was sent by automated email to the point of contact at the local program.

A second round of data was collected when the child was about 15 months old. These include:

(1) a one-hour telephone interview (the family follow-up survey), (2) a 30-minute video-recording of the mother and child playing with some toys (the Three Bags task), (3) a direct assessment of the child's receptive language skills (expected to take 40 minutes), (4) measurement of the child's weight and height and the mother's weight (expected to take 5 minutes), and (5) observations of the family's home environment, which will not add time to the data collection procedures. Finally, data were collected from three state systems: (1) Medicaid, (2) vital records, and (3) child welfare. Follow-up data collection plans have been approved by the federal Office of Management and Budget.

The family follow-up survey included information on several domains specified in the ACA:

infant and child health; child development; parental health and well-being; parenting practices, attitudes, and beliefs; domestic violence; history with the criminal justice system; family economic self-sufficiency; and use of social services. Survey questions focused on outcomes for which previous studies of home visiting have found effects and on outcomes that would not be available from other sources (such as administrative records).

Follow-up data collection also included several types of data collected in the family's home:

1. Direct assessments of children's receptive language skills will be done using the Preschool Language Scales-5 Auditory Comprehension Scale (PLS-5), which is an individually administered test that assesses the child's ability to understand language. During the assessment, the child sat on the mother's lap while the field interviewer administered this test. At 15 months, toddlers' spoken language capabilities are only just beginning to develop. For this reason, the Auditory Comprehension subtest of the PLS-5 was used. The Auditory Comprehension cluster measures a child's ability to be attentive and respond to stimuli in the environment and to comprehend basic vocabulary or gestures.

2. During the follow-up visit, field staff used a measuring tape and a weighing scale when they conduct field visits, which they will use to obtain both the mother's weight and the child's height and weight. Direct measurements of the child's weight and length will provide information on whether the child's growth is within a normal range or exhibits early signs of unhealthy growth trajectories (i.e., risk of obesity or under-development). Measurement of the mother's weight along with self-reported height will provide information on whether the mother is obese, which is associated with a host of other health problems. When measuring weight, if the child is willing, the field interviewer will ask him or her to stand on the weighing scale by him or herself. If the child is unwilling to do so, then the staff person will obtain the mother's weight and then ask her to pick up the child and stand on the scale with the child. The mother's weight will then be subtracted from this total weight to obtain the child's weight. These measures are being collected out of concern that the mother may not accurately report her own weight and may not know her child's current weight and height.

3. The Home Observation for Measuring the Environment (HOME) - described under baseline data collection -- was conducted again at follow-up.

4. The three bags task, a direct observation of parent-child interactions, was conducted. This assessment is intended to capture the parenting constructs of parental sensitivity, cognitive stimulation, positive regard, intrusiveness, negative regard, detachment, relationship quality (degree of relatedness and mutual engagement), and boundary dissolution (parent's inability to maintain an appropriate role in his or her interaction with child). From this task, children's behaviors towards the parent will also be gathered in the context of the parent-child interaction, including engagement with the parent, sustained attention, and negativity towards the parent.

In addition, the study asked approximately 500 home visitors and 100 supervisors in the 85 sites to enroll in the study. Some supervisors may also see families and carry a caseload, acting in the capacity of both supervisor and supervisor. Program staff were identified by a local program manager and sent emails by the study team asking them to enroll in the study. Home visitors and supervisors were asked to complete a 75-minute web-based survey around the time that the site enters the study. The home visitor and supervisor baseline surveys collected information on staff characteristics and on staff perceptions of organizational factors related to service delivery; employment, supervision and program outcomes; staff beliefs about home visitor roles and responsibilities, ratings of her or his own training and skills in supervising staff to carry out activities; ratings of her or his own ability to secure supervision and professional consultation; and demographics and individual background characteristics. Individuals who are both home visitors and supervisors were asked to complete a survey that combined elements of the home visitor and supervisor surveys, and lasted about 105 minutes. Because the surveys included sensitive information, home visitors and supervisors were asked to consent to the survey and home visitors were asked to consent to videotaped interactions with families. Home visitors and supervisors were asked to provide consent through a web-based application before completing the web-based surveys.

Home visitors and supervisors were asked to complete a 75-minute web-based survey again a year after enrolling in the study. Staff who are both home visitors and supervisors were asked to complete a 105-minute web-based survey again a year after enrolling in the study. Staff follow-up surveys parallel the baseline surveys. They measured malleable respondent characteristics and perceptions of organizational factors related to service delivery.

MIHOPE has also completed two additional follow-up surveys that were conducted around the time the child turns 2 ½ and 3 ½ years old. At those two points in time, the mother - or the child's primary caregiver if the mother was not available - was asked to take part in a short survey. The survey included about 15 minutes of questions on topics such as child and parental health, parenting style, child development, and social services used. The caregiver was also asked to provide updated contact information, as well as share information about people who may know how to locate her in the future.

MIHOPE has also begun a round of data collection with families when children are in kindergarten. The following data sources are being collected at kindergarten: (1) a one-hour structured interview with caregivers, (2) direct assessments of children to assess the child's receptive language skills, early numeracy, working memory, inhibitory control, and cognitive flexibility; (3) observations of caregiver-child interactions to measure children's behaviors towards the caregiver and the caregiver's parenting behaviors; and (4) a survey of the child's teachers on the child's behavior, such as learning behaviors. Administrative records data will also be collected. Specifically, the study will continue to collect child welfare, Medicaid, and National Directory of New Hires data. The study will also collect school records.

A 15-minute web-based survey is being fielded with all study participants to learn about economic self-sufficiency and maternal health and well-being during the COVID-19 pandemic.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4232
• Est. completion date: September 2025
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Eligible for home visiting program selected to be in the study

• At least 15 years old

• Pregnant or have a child under 28 weeks old

Exclusion Criteria:

• women already enrolled in home visiting (for example, with an older child)

• children in foster care in sites using EHS program model

• homeless families in sites using EHS program model

• women who speak neither English or Spanish

Related Conditions & MeSH terms

• Infant Development
• Pregnancy

Intervention

Other:
• Home visiting
Home visits are used to assess family needs, provide support and education, and make referrals to relevant community services. The goals of the programs are to improve child health and development, promote positive parenting, prevent child maltreatment, improve maternal and child health, and increasing parental self-sufficiency.

Locations

Country	Name	City	State
United States	MDRC	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
MDRC	Columbia University, James Bell Associates, Johns Hopkins University, Mathematica Policy Research, Inc., University of Georgia

Country where clinical trial is conducted

United States, 

References & Publications (3)

Charles Michalopoulos, Anne Duggan, Virginia Knox, Jill H. Filene, Helen Lee, Emily K. Snell, Sarah Crowne, Erika Lundquist, Phaedra S. Corso, Justin B. Ingels (2013). Revised Design for the Mother and Infant Home Visiting Program Evaluation. OPRE Report 2013-18. Washington, DC: Office of Planning, Research and Evaluation, Administration for Children and Families, U.S. Department of Health and Human Services.

Charles Michalopoulos, Helen Lee, Anne Duggan, Erika Lundquist, Ada Tso, Sarah Crowne, Lori Burrell, Jennifer Somers, Jill H. Filene, and Virginia Knox. (2015). The Mother and Infant Home Visiting Program Evaluation: Early Findings on the Maternal, Infant

Charles Michalopoulos, Kristen Faucetta, Carolyn J. Hill, Ximena A. Portilla, Lori Burrell, Helen Lee, Anne Duggan, and Virginia Knox. (2019). Impacts on Family Outcomes of Evidence-Based Early Childhood Home Visiting: Results from the Mother and Infant H

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	New birth after study entry	Mother reports having given birth to one or more children after study entry	When focal child is 2.5 years old and when focal child is 3.5 years old
Other	Maternal depressive symptoms	Whether mother reports depressive symptoms based on the CESD-10 scale	When focal child is 2.5 years old and when focal child is 3.5 years old
Other	Health status of mother is rated "fair" or "poor"	Whether mother reported her health was fair or poor	When focal child is 2.5 years old and when focal child is 3.5 years old
Other	Number of child emergency department visits for accident or injury	Mother's report of number of visits to the ED for the child for accidents or injuries	From age 15 months to 2.5 years for the child, and from 2.5 years to 3.5 years
Other	Mother is pursuing education or training	Whether the mother indicates she is currently receiving training or education	When focal child is 2.5 years old and when focal child is 3.5 years old
Other	Use of yelling as a disciplinary practice	Mother's report of yelling at the child as a disciplinary practice	When focal child is 2.5 years old and when focal child is 3.5 years old
Primary	New pregnancy after study entry	Mother has had one or more pregnancies since study entry	through child's 15th month
Primary	Any health encounter for injury or ingestion	Whether the child has had an injury or ingestion that lead to a health encounter.	through child's 15th month
Primary	Number of well-child visits	Number of well-child visits	through child's 15th month
Primary	Parental supportiveness	Parental supportiveness measured from Three Bags interaction of parent with child	at child's 15th month
Primary	Quality of home environment	Quality of home environment measured using the IT-HOME	at child's 15th month
Primary	Child has health insurance coverage	Whether the child has health insurance coverage	at child's 15th month
Primary	Behavior problems	Behavior problems total score from the BITSEA parent report	at child's 15th month
Primary	Frequency of minor physical assault of child	Whether parent reports indicate child has been victim of minor physical assault	through child's 15th month
Primary	Frequency of psychological aggression	Whether parent reports indicate child has been victim of psychological aggression	through the child's 15th month
Primary	Any child ED use	Whether child has visited the ED	through child's 15th month
Primary	Language skills in the normal range	Whether child has language skills in the normal range, as measured through a direct assessment	at child's 15th month
Primary	Parent receiving education or training	Whether parent is receiving education or training	at child's 15th month

External Links

•   MIHOPE impacts at 15 months
•   MIHOPE Report to Congress (cited above)