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Completed

NCT Number: NCT01458145

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.

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Key information

Age range

14 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cornell Scott Hill Health Center, New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No psychoses or terminal illnesses

Treatment and study plan

Minding the Baby Home Visiting Program

Behavioral

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Oct 24, 2011
Registry last updated
Jan 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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