- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01458145
Minding the Baby Home Visiting: Program Evaluation
January 12, 2018 updated by: Yale University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
151
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06511
- Fair Haven Community Health Center
-
New Haven, Connecticut, United States, 06519
- Cornell Scott Hill Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 23 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Having a first child
- Speak English
- Obtains primary care from community health centers
Exclusion Criteria:
- No psychoses or terminal illnesses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Home visits
|
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: routine primary care at community health center
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal reflective capacities
Time Frame: 27 months
|
Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.
|
27 months
|
Infant Attachment
Time Frame: 14 months
|
Attachment pattern of child as measured by Strange Situation Procedure
|
14 months
|
Maternal life course outcomes
Time Frame: 24 months
|
Ability to delay rapid subsequent childbearing within 24 months of first child's birth
|
24 months
|
child abuse or neglect
Time Frame: 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose of intervention
Time Frame: 24 months
|
Frequency, duration and content of home visits during the intervention
|
24 months
|
cost analysis for the program
Time Frame: 27 months
|
cost analysis of program and outcomes regarding health and health service use
|
27 months
|
Description of reflective functioning in pregnant adolescents
Time Frame: baseline
|
qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lois S Sadler, PhD, Yale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2009
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
October 3, 2011
First Submitted That Met QC Criteria
October 20, 2011
First Posted (Estimate)
October 24, 2011
Study Record Updates
Last Update Posted (Actual)
January 17, 2018
Last Update Submitted That Met QC Criteria
January 12, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17098
- R01HD057947 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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