Minding the Baby Home Visiting: Program Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01458145
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : January 17, 2018
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Yale University

October 3, 2011
October 24, 2011
January 17, 2018
September 2009
March 2016   (Final data collection date for primary outcome measure)
  • Maternal reflective capacities [ Time Frame: 27 months ]
    Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.
  • Infant Attachment [ Time Frame: 14 months ]
    Attachment pattern of child as measured by Strange Situation Procedure
  • Maternal life course outcomes [ Time Frame: 24 months ]
    Ability to delay rapid subsequent childbearing within 24 months of first child's birth
  • 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
Same as current
Complete list of historical versions of study NCT01458145 on Archive Site
  • Dose of intervention [ Time Frame: 24 months ]
    Frequency, duration and content of home visits during the intervention
  • cost analysis for the program [ Time Frame: 27 months ]
    cost analysis of program and outcomes regarding health and health service use
  • Description of reflective functioning in pregnant adolescents [ Time Frame: baseline ]
    qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy
Same as current
Not Provided
Not Provided
Minding the Baby Home Visiting: Program Evaluation
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 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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Attachment
  • Child Maltreatment
  • Maternal Sensitivity
  • Infant Health
Behavioral: Minding 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
  • Experimental: Home visits
    Intervention: Behavioral: Minding the Baby Home Visiting Program
  • No Intervention: routine primary care at community health center

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2016
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • No psychoses or terminal illnesses
Sexes Eligible for Study: All
14 Years to 25 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
R01HD057947 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Yale University
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Lois S Sadler, PhD Yale University
Yale University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP