Minding the Baby Home Visiting: Program Evaluation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01458145
First received: October 3, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Attachment
Child Maltreatment
Maternal Sensitivity
Infant Health
Behavioral: Minding the Baby Home Visiting Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Minding the Baby Home Visiting: Program Evaluation

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Maternal reflective capacities [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.

  • Infant Attachment [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Attachment pattern of child as measured by Strange Situation Procedure

  • Maternal life course outcomes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Ability to delay rapid subsequent childbearing within 24 months of first child's birth

  • child abuse or neglect [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    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:
  • Dose of intervention [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Frequency, duration and content of home visits during the intervention

  • cost analysis for the program [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    cost analysis of program and outcomes regarding health and health service use

  • Description of reflective functioning in pregnant adolescents [ Time Frame: baseline ] [ Designated as safety issue: No ]
    qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy


Enrollment: 151
Study Start Date: September 2009
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   14 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No psychoses or terminal illnesses
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01458145

Locations
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
Investigators
Principal Investigator: Lois S Sadler, PhD Yale University
  More Information

Publications:
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01458145     History of Changes
Other Study ID Numbers: R01HD057947
Study First Received: October 3, 2011
Last Updated: June 13, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 22, 2014