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Clinical Trials/NCT01458145
NCT01458145
Completed
Not Applicable

Minding the Baby Home Visiting: Program Evaluation

Yale University2 sites in 1 country151 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Attachment
Sponsor
Yale University
Enrollment
151
Locations
2
Primary Endpoint
Maternal reflective capacities
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
December 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • No psychoses or terminal illnesses

Outcomes

Primary Outcomes

Maternal reflective capacities

Time Frame: 27 months

Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.

Maternal life course outcomes

Time Frame: 24 months

Ability to delay rapid subsequent childbearing within 24 months of first child's birth

Infant Attachment

Time Frame: 14 months

Attachment pattern of child as measured by Strange Situation Procedure

child abuse or neglect

Time Frame: 24 months

Reports of an open case with child protective services for parents and children within the study; documented by interview and health record

Secondary Outcomes

  • cost analysis for the program(27 months)
  • Dose of intervention(24 months)
  • Description of reflective functioning in pregnant adolescents(baseline)

Study Sites (2)

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