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Minding the Baby Home Visiting: Program Evaluation

Minding the Baby Home Visiting: Program Evaluation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01458145
Enrollment
151
Registered
2011-10-24
Start date
2009-09-30
Completion date
2016-12-31
Last updated
2018-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attachment, Child Maltreatment, Infant Health, Maternal Sensitivity

Brief summary

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.

Interventions

BEHAVIORALMinding the Baby Home Visiting Program

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

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Yale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
14 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

* Having a first child * Speak English * Obtains primary care from community health centers

Exclusion criteria

* No psychoses or terminal illnesses

Design outcomes

Primary

MeasureTime frameDescription
Maternal reflective capacities27 monthsCoded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.
Infant Attachment14 monthsAttachment pattern of child as measured by Strange Situation Procedure
Maternal life course outcomes24 monthsAbility to delay rapid subsequent childbearing within 24 months of first child's birth
child abuse or neglect24 monthsReports of an open case with child protective services for parents and children within the study; documented by interview and health record

Secondary

MeasureTime frameDescription
cost analysis for the program27 monthscost analysis of program and outcomes regarding health and health service use
Description of reflective functioning in pregnant adolescentsbaselinequalitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy
Dose of intervention24 monthsFrequency, duration and content of home visits during the intervention

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026