Minding the Baby Home Visiting: Program Evaluation

NCT ID: NCT01458145

Last Updated: 2018-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2016-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Home visits

Group Type: EXPERIMENTAL

Minding the Baby Home Visiting Program

Intervention Type: 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

routine primary care at community health center

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• No psychoses or terminal illnesses

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lois S Sadler, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Fair Haven Community Health Center

New Haven, Connecticut, United States

Cornell Scott Hill Health Center

New Haven, Connecticut, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21320683 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21884518 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37126599 (View on PubMed)

Other Identifiers

R01HD057947

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17098

Identifier Type: -

Identifier Source: org_study_id