This trial is active, not recruiting.

Conditions attachment, child maltreatment, maternal sensitivity, infant health
Treatment minding the baby home visiting program
Phase phase 3
Sponsor Yale University
Start date September 2009
End date March 2016
Trial size 151 participants
Trial identifier NCT01458145, R01HD057947


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
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)

Primary Outcomes

Maternal reflective capacities
time frame: 27 months
Infant Attachment
time frame: 14 months
Maternal life course outcomes
time frame: 24 months
child abuse or neglect
time frame: 24 months

Secondary Outcomes

Dose of intervention
time frame: 24 months
cost analysis for the program
time frame: 27 months
Description of reflective functioning in pregnant adolescents
time frame: baseline

Eligibility Criteria

Male or female participants from 14 years up to 25 years old.

Inclusion Criteria: - Having a first child - Speak English - Obtains primary care from community health centers Exclusion Criteria: - No psychoses or terminal illnesses

Additional Information

Official title Minding the Baby Home Visiting: Program Evaluation
Principal investigator Lois S Sadler, PhD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Yale University.