Minding the Baby Home Visiting: Program Evaluation

Study Overview
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Brief Summary
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This is an efficacy study of an intensive home visitation intervention, Minding the Baby (MTB). This reflective parenting program (aimed at enhancing maternal reflective capacities), is focused on first-time young mothers and infants living in an urban community. The study, grounded in attachment and human ecology theories integrates advanced practice nursing and mental health care by pairing master's level nurse practitioners and social workers with at-risk young families. Aims of the study are: 1) to determine the efficacy of the MTB intervention in young mothers and infants with respect to a) maternal outcome variables including the quality of the mother-infant relationship, maternal reflective capacities, maternal mastery/self-efficacy, parental competence, and maternal health and life course outcomes (educational success, employment, delaying subsequent child-bearing); and b) infant outcome variables including early attachment, infant health, and developmental outcomes; 2) to monitor fidelity and dose of the program with young mothers; 3) to describe the evolution of reflective capacities in adolescent mothers (contrasting intervention group with control group) through descriptive qualitative analyses of transcribed Pregnancy Interviews and Parent Development Interviews at the last trimester of pregnancy and at 24 months; 4) to conduct cost-effectiveness analyses of the program. The longitudinal two-group study (subjects nested within randomly assigned groups), will include multi-method (self report, interview and direct observation and coding of behaviors) approaches with a cohort of first-time multi-ethnic mothers between the ages of 14-25 (and their infants). MTB home visits occur weekly for intervention families (n=69) beginning in mid pregnancy and continuing through the first year, and then bi-weekly through the second year. Mothers and infants (n=69) in the control group will receive standard prenatal, postpartum and pediatric primary care in one of two community health centers (as will the intervention group) and also receive monthly educational materials about child health and development mailed to their homes. Maternal and infant outcome variables will be followed over time (pregnancy, 4, 12, and 24 months) as well as compared between the 2 groups. Cost analyses and analysis of the dose and sample characteristics linked to efficacy, will allow us to plan for translation of the model into clinical care and community sustainability.

Official Title
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Minding the Baby Home Visiting: Program Evaluation

Conditions
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Attachment, Child Maltreatment, Maternal Sensitivity, Infant Health

Intervention / Treatment
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* Behavioral: Minding the Baby Home Visiting Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having a first child Speak English Obtains primary care from community health centers Exclusion Criteria: No psychoses or terminal illnesses

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home visits<br> | Behavioral: Minding the Baby Home Visiting Program<br>* Weekly home visits for one year followed by bi-weekly home visits until child is 24 months of age provided to young at risk families by a team of nurse practitioner and social worker home visitors<br>|
| No Intervention: routine primary care at community health center<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal reflective capacities | Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months. | 27 months | 
| Infant Attachment | Attachment pattern of child as measured by Strange Situation Procedure | 14 months | 
| Maternal life course outcomes | Ability to delay rapid subsequent childbearing within 24 months of first child's birth | 24 months | 
| child abuse or neglect | Reports of an open case with child protective services for parents and children within the study; documented by interview and health record | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of intervention | Frequency, duration and content of home visits during the intervention | 24 months | 
| cost analysis for the program | cost analysis of program and outcomes regarding health and health service use | 27 months | 
| Description of reflective functioning in pregnant adolescents | qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy | baseline |