Minding the Baby Home Visiting: Program Evaluation

NCT01458145 | Completed DMC

• 2 other identifiers: 17098R01HD057947
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 2

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.

Conditions

Attachment; Child Maltreatment; Maternal Sensitivity; Infant Health

Outcome Measures

Primary Outcomes (4)

• Maternal reflective capacities

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

  27 months

• Infant Attachment

  Attachment pattern of child as measured by Strange Situation Procedure

  14 months

• Maternal life course outcomes

  Ability to delay rapid subsequent childbearing within 24 months of first child's birth

  24 months

• child abuse or neglect

  Reports of an open case with child protective services for parents and children within the study; documented by interview and health record

  24 months

Secondary Outcomes (3)

• Dose of intervention

  24 months

• cost analysis for the program

  27 months

• Description of reflective functioning in pregnant adolescents

  baseline

Study Arms (2)

Home visits

EXPERIMENTAL

Behavioral: Minding the Baby Home Visiting Program

routine primary care at community health center

NO INTERVENTION

Interventions

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

Home visits

Eligibility Criteria

• Age: 14 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• No psychoses or terminal illnesses

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Fair Haven Community Health Center

New Haven, Connecticut, 06511, United States

Location

Cornell Scott Hill Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (3)

• Flaherty SC, Sadler LS. A review of attachment theory in the context of adolescent parenting. J Pediatr Health Care. 2011 Mar-Apr;25(2):114-21. doi: 10.1016/j.pedhc.2010.02.005. Epub 2010 May 1.

  PMID: 21320683 BACKGROUND

• Sadler LS, Newlin KH, Johnson-Spruill I, Jenkins C. Beyond the medical model: interdisciplinary programs of community-engaged health research. Clin Transl Sci. 2011 Aug;4(4):285-97. doi: 10.1111/j.1752-8062.2011.00316.x.

  PMID: 21884518 BACKGROUND

• Londono Tobon A, Condon E, Slade A, Holland ML, Mayes LC, Sadler LS. Participation in an Attachment-Based Home Visiting Program Is Associated with Lower Child Salivary C-Reactive Protein Levels at Follow-Up. J Dev Behav Pediatr. 2023 May 1;44(4):e292-e299. doi: 10.1097/DBP.0000000000001180.

  PMID: 37126599 DERIVED

Study Officials

• Lois S Sadler, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 24, 2011
• Study Start: September 1, 2009
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

US (2)