Minding the Baby Home Visiting: Program Evaluation

Not Applicable

Completed

• Conditions: Child Maltreatment; Maternal Sensitivity; Attachment; Infant Health
• Interventions: Behavioral: Minding the Baby Home Visiting Program

• Registration Number: NCT01458145
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-10-03
• Study First Submitted QC: 2011-10-20
• Study First Posted: 2011-10-24
• Primary Completion: 2016-03
• Study Completion: 2016-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-12
• Last Update Posted: 2018-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

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

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Exclusion Criteria

• No psychoses or terminal illnesses

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home visits	Minding the Baby Home Visiting Program	-

Primary Outcome Measures

Name	Time	Method
Maternal reflective capacities	27 months	Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.
Maternal life course outcomes	24 months	Ability to delay rapid subsequent childbearing within 24 months of first child's birth
Infant Attachment	14 months	Attachment pattern of child as measured by Strange Situation Procedure
child abuse or neglect	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 Outcome Measures

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

Trial Locations

Locations (2)

Fair Haven Community Health Center; 🇺🇸 New Haven, Connecticut, United States

Cornell Scott Hill Health Center; 🇺🇸 New Haven, Connecticut, United States