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NCT01458145 · ClinicalTrials.gov registry record · NA

Minding the Baby Home Visiting: Program Evaluation

A NA study of Child Maltreatment and Attachment, sponsored by Yale University.

Completed
Registry status
NA
Development phase
151
Enrollment target
2
Study locations

NCT01458145: Completed NA study of Child Maltreatment and Attachment, sponsored by Yale University.

NCT01458145 is a NA study of Child Maltreatment and Attachment that has completed, run by Yale University. The registered enrollment target is 151 participants, below the 2,449-participant average among 17 other Child Maltreatment trials with a reported enrollment target (94% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01458145, a NA study of Child Maltreatment and Attachment, has completed, sponsored by Yale University.

COMPLETED
Registry status
NA
Development phase
151 participants
Enrollment target
2
Study locations

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 tw

Primary Outcome

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

Interventions

  • BEHAVIORAL Minding the Baby Home Visiting Program

Study Locations (2)

Connecticut

  • Fair Haven Community Health Center - New Haven
  • Cornell Scott Hill Health Center - New Haven

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2009-09
Est. Completion 2016-12
Phase NA
Yale University

1,492 total trials

What the finished NCT01458145 record still lists

NCT01458145 is an interventional study that assigns participants to a tested intervention. The registered 151 participants enrollment target is mid-sized for trials with a published cap, below the 2,449-participant average among 17 other Child Maltreatment trials with a reported enrollment target (94% lower).

The record links to 4 conditions, with Child Maltreatment appearing as the primary indexed condition, and to 1 intervention - of which Minding the Baby Home Visiting Program is the first listed.

NCT01458145 reports a single indexed study location in Connecticut.

Frequently Asked Questions

What is clinical trial NCT01458145 about?

NCT01458145 is a clinical study titled "Minding the Baby Home Visiting: Program Evaluation". 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 ...

What is the current status of trial NCT01458145?

This trial is currently completed. It is a NA study. The enrollment target is 151 participants. The study started on 2009-09. Estimated completion is 2016-12.

What conditions does trial NCT01458145 study?

This clinical trial studies the following conditions: Child Maltreatment, Attachment, Maternal Sensitivity, Infant Health.

What interventions are being tested in trial NCT01458145?

The interventions under investigation include: Minding the Baby Home Visiting Program (BEHAVIORAL).

Who is sponsoring clinical trial NCT01458145?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01458145 being conducted?

This trial has 2 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Child Maltreatment

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01458145's enrollment target sits among peer trials

151 14th of 17 higher than 4 of 17 other Child Maltreatment trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Child Maltreatment trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01458145, the US trial registry maintained by the National Library of Medicine. NCT01458145 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.