Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
5100

Summary

Conditions
  • Infant Development
  • Pregnancy
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 15 years and 125 years
Gender
Only males

Description

MIHOPE includes two groups of participants. First, the study will include 4300 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 ...

MIHOPE includes two groups of participants. First, the study will include 4300 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 will be recruited as follows. Mothers will be 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 will then enter the mother's address and phone number. In addition, the home visiting program will provide 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 has determined that a partial authorization of the HIPAA Authorization requirement is warranted for use of the mother's information for sample recruitment. Study field staff will attempt 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 will be 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 are also providing 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 is a non-emancipated minor, assent will be obtained and written consent will be obtained from her parent or guardian if the parent or guardian is in the home at the time of the recruitment visit. If the parent or guardian is not in the home, verbal consent will be obtained. If verbal consent is provided, the parent or guardian will be mailed a copy of the assent form that the woman signed and that explains what the research entails. After consent has been provided, study staff in the family's home will initiate a call to the study's survey operations center for purposes of administering a one-hour survey. The family baseline survey will include 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 will collect information on demographics and household composition to describe the study sample, and will collect information on demographics and household composition to describe the study sample, and will collect contact information for family members or friends who can help locate the family at follow-up if they move. The survey also contains information about the parent's expectations regarding the home visiting program, which will inform research on program implementation. While the mother is completing the baseline survey by phone, the study field staff will conduct 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 will hang up and determine whether the family is 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 will be sent by automated email to the point of contact at the local program. A second round of data will be collected when the child is 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 will be 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 will include 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 will focus 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 will also include several types of data collected in the family's home: 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. The child will sit on the mother's lap while the field interviewer administers 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 will be 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. During the follow-up visit, field staff will have 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. The Home Observation for Measuring the Environment (HOME) - described under baseline data collection -- will be conducted again at follow-up. The three bags task, a direct observation of parent-child interactions, will be 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 is asking 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 will be identified by a local program manager and sent emails by the study team asking them to enroll in the study. Home visitors and supervisors will be 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 will collect 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 will be asked to complete a survey that combines elements of the home visitor and supervisor surveys, and lasts about 105 minutes. Because the surveys include sensitive information, home visitors and supervisors will be asked to consent to the survey and home visitors will be asked to consent to videotaped interactions with families. Home visitors and supervisors will be asked to provide consent through a web-based application before completing the web-based surveys. Home visitors and supervisors will be 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 will be 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 will measure 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.

Tracking Information

NCT #
NCT02069782
Collaborators
  • Mathematica Policy Research, Inc.
  • Johns Hopkins University
  • University of Georgia
  • Columbia University
  • James Bell Associates
Investigators
Principal Investigator: Charles Michalopoulos, PhD MDRC Principal Investigator: Virginia Knox, PhD MDRC Principal Investigator: Anne Duggan, ScD Johns Hopkins University