An interventional study of Minding the Baby Home Visiting Program in Attachment, Child Maltreatment and Maternal Sensitivity, sponsored by Yale University. Completed at 2 sites in United States. Open to participants aged 14 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-17.
Sponsored by Yale University · Not applicable, Interventional, and Prevention
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.
1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.
This study's enrollment of 151 is above the median of 57 across 1,384 interventional studies indexed under Hypersensitivity.
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Exclusion Criteria:
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
Maternal reflective capacities
Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.
Time frame: 27 months
Infant Attachment
Attachment pattern of child as measured by Strange Situation Procedure
Time frame: 14 months
Maternal life course outcomes
Ability to delay rapid subsequent childbearing within 24 months of first child's birth
Time frame: 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
Time frame: 24 months
Dose of intervention
Frequency, duration and content of home visits during the intervention
Time frame: 24 months
cost analysis for the program
cost analysis of program and outcomes regarding health and health service use
Time frame: 27 months
Description of reflective functioning in pregnant adolescents
qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy
Time frame: baseline
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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