Minding the Baby Home Visiting: Program Evaluation
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ClinicalTrials.gov Identifier: NCT01458145 |
Recruitment Status
:
Completed
First Posted
: October 24, 2011
Last Update Posted
: January 17, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Attachment Child Maltreatment Maternal Sensitivity Infant Health | Behavioral: Minding the Baby Home Visiting Program | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 151 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Minding the Baby Home Visiting: Program Evaluation |
Actual Study Start Date : | September 2009 |
Actual Primary Completion Date : | March 2016 |
Actual Study Completion Date : | December 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: Home visits |
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
|
No Intervention: routine primary care at community health center |
- Maternal reflective capacities [ Time Frame: 27 months ]Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.
- Infant Attachment [ Time Frame: 14 months ]Attachment pattern of child as measured by Strange Situation Procedure
- Maternal life course outcomes [ Time Frame: 24 months ]Ability to delay rapid subsequent childbearing within 24 months of first child's birth
- 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
- Dose of intervention [ Time Frame: 24 months ]Frequency, duration and content of home visits during the intervention
- cost analysis for the program [ Time Frame: 27 months ]cost analysis of program and outcomes regarding health and health service use
- Description of reflective functioning in pregnant adolescents [ Time Frame: baseline ]qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy

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Ages Eligible for Study: | 14 Years to 25 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Having a first child
- Speak English
- Obtains primary care from community health centers
Exclusion Criteria:
- No psychoses or terminal illnesses

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458145
United States, Connecticut | |
Fair Haven Community Health Center | |
New Haven, Connecticut, United States, 06511 | |
Cornell Scott Hill Health Center | |
New Haven, Connecticut, United States, 06519 |
Principal Investigator: | Lois S Sadler, PhD | Yale University |
Publications:
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT01458145 History of Changes |
Other Study ID Numbers: |
17098 R01HD057947 ( U.S. NIH Grant/Contract ) |
First Posted: | October 24, 2011 Key Record Dates |
Last Update Posted: | January 17, 2018 |
Last Verified: | January 2018 |