Minding the Baby Home Visiting: Program Evaluation

Child Maltreatment Clinical Trial

Official title:

Minding the Baby Home Visiting: Program Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01458145
• Other study ID #: 17098
• Secondary ID: R01HD057947
• Status: Completed
• Phase: N/A
• First received: October 3, 2011
• Last updated: January 12, 2018
• Start date: September 2009
• Est. completion date: December 2016

Study information

• Verified date: January 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 25 Years

Eligibility

Inclusion Criteria:

• Having a first child

• Speak English

• Obtains primary care from community health centers

Exclusion Criteria:

• No psychoses or terminal illnesses

Related Conditions & MeSH terms

• Attachment
• Child Maltreatment
• Infant Health
• Maternal Sensitivity

Intervention

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

Locations

Country	Name	City	State
United States	Cornell Scott Hill Health Center	New Haven	Connecticut
United States	Fair Haven Community Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal reflective capacities	Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.	27 months
Primary	Infant Attachment	Attachment pattern of child as measured by Strange Situation Procedure	14 months
Primary	Maternal life course outcomes	Ability to delay rapid subsequent childbearing within 24 months of first child's birth	24 months
Primary	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	Dose of intervention	Frequency, duration and content of home visits during the intervention	24 months
Secondary	cost analysis for the program	cost analysis of program and outcomes regarding health and health service use	27 months
Secondary	Description of reflective functioning in pregnant adolescents	qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy	baseline