Minding the Baby Home Visiting: Program Evaluation
Primary Purpose
Attachment, Child Maltreatment, Maternal Sensitivity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Minding the Baby Home Visiting Program
Sponsored by
About this trial
This is an interventional prevention trial for Attachment
Eligibility Criteria
Inclusion Criteria:
- Having a first child
- Speak English
- Obtains primary care from community health centers
Exclusion Criteria:
- No psychoses or terminal illnesses
Sites / Locations
- Fair Haven Community Health Center
- Cornell Scott Hill Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Home visits
routine primary care at community health center
Arm Description
Outcomes
Primary Outcome Measures
Maternal reflective capacities
Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.
Infant Attachment
Attachment pattern of child as measured by Strange Situation Procedure
Maternal life course outcomes
Ability to delay rapid subsequent childbearing within 24 months of first child's birth
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
Secondary Outcome Measures
Dose of intervention
Frequency, duration and content of home visits during the intervention
cost analysis for the program
cost analysis of program and outcomes regarding health and health service use
Description of reflective functioning in pregnant adolescents
qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy
Full Information
NCT ID
NCT01458145
First Posted
October 3, 2011
Last Updated
January 12, 2018
Sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01458145
Brief Title
Minding the Baby Home Visiting: Program Evaluation
Official Title
Minding the Baby Home Visiting: Program Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attachment, Child Maltreatment, Maternal Sensitivity, Infant Health
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home visits
Arm Type
Experimental
Arm Title
routine primary care at community health center
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Minding the Baby Home Visiting Program
Intervention Description
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
Primary Outcome Measure Information:
Title
Maternal reflective capacities
Description
Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.
Time Frame
27 months
Title
Infant Attachment
Description
Attachment pattern of child as measured by Strange Situation Procedure
Time Frame
14 months
Title
Maternal life course outcomes
Description
Ability to delay rapid subsequent childbearing within 24 months of first child's birth
Time Frame
24 months
Title
child abuse or neglect
Description
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
Secondary Outcome Measure Information:
Title
Dose of intervention
Description
Frequency, duration and content of home visits during the intervention
Time Frame
24 months
Title
cost analysis for the program
Description
cost analysis of program and outcomes regarding health and health service use
Time Frame
27 months
Title
Description of reflective functioning in pregnant adolescents
Description
qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Having a first child
Speak English
Obtains primary care from community health centers
Exclusion Criteria:
No psychoses or terminal illnesses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lois S Sadler, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fair Haven Community Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Cornell Scott Hill Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21320683
Citation
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.
Results Reference
background
PubMed Identifier
21884518
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.
Results Reference
background
Learn more about this trial
Minding the Baby Home Visiting: Program Evaluation
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