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CompletedNCT01458145Updated Jan 17, 2018

Minding the Baby Home Visiting: Program Evaluation

An interventional study of Minding the Baby Home Visiting Program in Attachment, Child Maltreatment and Maternal Sensitivity, sponsored by Yale University. Completed at 2 sites in United States. Open to participants aged 14 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by Yale University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Sep 2009, registered Oct 2011).
Phase
Not applicable
Study type
Interventional
Enrollment
151
Allocation
Randomized
Ages
14 Years to 25 Years
Sex
All
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Study 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.

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Conditions studied

  • Attachment
  • Child Maltreatment
  • Maternal Sensitivity
  • Infant Health

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03

In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 151 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
14 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No psychoses or terminal illnesses
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
151 participants (actual)

Study arms

  • Experimental
    Home visits

    Behavioral: Minding the Baby Home Visiting Program

  • No intervention
    routine primary care at community health center

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

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What researchers measure

Primary outcomes

  1. Maternal reflective capacities

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

    Time frame: 27 months

  2. Infant Attachment

    Attachment pattern of child as measured by Strange Situation Procedure

    Time frame: 14 months

  3. Maternal life course outcomes

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

    Time frame: 24 months

  4. 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

    Time frame: 24 months

Secondary outcomes

  1. Dose of intervention

    Frequency, duration and content of home visits during the intervention

    Time frame: 24 months

  2. cost analysis for the program

    cost analysis of program and outcomes regarding health and health service use

    Time frame: 27 months

  3. Description of reflective functioning in pregnant adolescents

    qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy

    Time frame: baseline

07

Study locations

2 sites
  • Fair Haven Community Health Center
    New Haven, Connecticut 06511, United States
  • Cornell Scott Hill Health Center
    New Haven, Connecticut 06519, United States
08

References and documents

Publications

  • Flaherty SC, Sadler LS. A review of attachment theory in the context of adolescent parenting. J Pediatr Health Care. 2011 Mar-Apr;25(2):114-21. doi: 10.1016/j.pedhc.2010.02.005. Epub 2010 May 1. PubMed 21320683 ↗
  • Sadler LS, Newlin KH, Johnson-Spruill I, Jenkins C. Beyond the medical model: interdisciplinary programs of community-engaged health research. Clin Transl Sci. 2011 Aug;4(4):285-97. doi: 10.1111/j.1752-8062.2011.00316.x. PubMed 21884518 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01458145
Lead sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Sponsor
First posted
Oct 24, 2011
Start date
Sep 2009
Primary completion
Mar 2016
Completion
Dec 2016
Last update
Jan 17, 2018

Study contacts

Lois S Sadler, PhD
principal investigator · Yale University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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