Minding the Baby Home Visiting: Program Evaluation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01458145
First received: October 3, 2011
Last updated: June 13, 2014
Last verified: June 2014

October 3, 2011
June 13, 2014
September 2009
August 2014   (final data collection date for primary outcome measure)
  • Maternal reflective capacities [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    Coded interview data from Pregnancy Interviews in third trimester and Parent Development Interviews at 24 months.
  • Infant Attachment [ Time Frame: 14 months ] [ Designated as safety issue: No ]
    Attachment pattern of child as measured by Strange Situation Procedure
  • Maternal life course outcomes [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Ability to delay rapid subsequent childbearing within 24 months of first child's birth
  • child abuse or neglect [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Reports of an open case with child protective services for parents and children within the study; documented by interview and health record
Same as current
Complete list of historical versions of study NCT01458145 on ClinicalTrials.gov Archive Site
  • Dose of intervention [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Frequency, duration and content of home visits during the intervention
  • cost analysis for the program [ Time Frame: 27 months ] [ Designated as safety issue: No ]
    cost analysis of program and outcomes regarding health and health service use
  • Description of reflective functioning in pregnant adolescents [ Time Frame: baseline ] [ Designated as safety issue: No ]
    qualitative analysis of Pregnancy Interview transcripts from adolescent participants in third trimester of pregnancy
Same as current
Not Provided
Not Provided
 
Minding the Baby Home Visiting: Program Evaluation
Minding the Baby Home Visiting: Program Evaluation

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
  • Attachment
  • Child Maltreatment
  • Maternal Sensitivity
  • Infant Health
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
  • Experimental: Home visits
    Intervention: Behavioral: Minding the Baby Home Visiting Program
  • No Intervention: routine primary care at community health center
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
151
November 2014
August 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Having a first child
  • Speak English
  • Obtains primary care from community health centers

Exclusion Criteria:

  • No psychoses or terminal illnesses
Both
14 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01458145
R01HD057947
Yes
Yale University
Yale University
Not Provided
Principal Investigator: Lois S Sadler, PhD Yale University
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP