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Trial record 1 of 1 for:    NCT01458145
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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

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.

Condition or disease Intervention/treatment Phase
Attachment Child Maltreatment Maternal Sensitivity Infant Health Behavioral: Minding the Baby Home Visiting Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 151 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Minding the Baby Home Visiting: Program Evaluation
Actual Study Start Date : September 2009
Actual Primary Completion Date : March 2016
Actual Study Completion Date : December 2016

Arm Intervention/treatment
Experimental: Home visits 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

No Intervention: routine primary care at community health center

Primary Outcome Measures :
  1. Maternal reflective capacities [ Time Frame: 27 months ]
    Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.

  2. Infant Attachment [ Time Frame: 14 months ]
    Attachment pattern of child as measured by Strange Situation Procedure

  3. Maternal life course outcomes [ Time Frame: 24 months ]
    Ability to delay rapid subsequent childbearing within 24 months of first child's birth

  4. 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

Secondary Outcome Measures :
  1. Dose of intervention [ Time Frame: 24 months ]
    Frequency, duration and content of home visits during the intervention

  2. cost analysis for the program [ Time Frame: 27 months ]
    cost analysis of program and outcomes regarding health and health service use

  3. Description of reflective functioning in pregnant adolescents [ Time Frame: baseline ]
    qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • No psychoses or terminal illnesses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01458145

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United States, Connecticut
Fair Haven Community Health Center
New Haven, Connecticut, United States, 06511
Cornell Scott Hill Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Lois S Sadler, PhD Yale University
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Responsible Party: Yale University Identifier: NCT01458145    
Other Study ID Numbers: 17098
R01HD057947 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Immune System Diseases