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Minding the Baby Home Visiting: Program Evaluation

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Yale University

Status

Completed

Conditions

Infant Health
Attachment
Child Maltreatment
Maternal Sensitivity

Treatments

Behavioral: Minding the Baby Home Visiting Program

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01458145
R01HD057947 (U.S. NIH Grant/Contract)
17098

Details and patient eligibility

About

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.

Enrollment

151 patients

Sex

All

Ages

14 to 25 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • No psychoses or terminal illnesses

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

151 participants in 2 patient groups

Home visits
Experimental group
Treatment:
Behavioral: Minding the Baby Home Visiting Program
routine primary care at community health center
No Intervention group

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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