Three-Part Program for Parents With Premature Infants
- Conditions
- Premature Birth
- Registration Number
- NCT00056680
- Lead Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Brief Summary
This study evaluated the efficacy of a comprehensive, three-part program for parents of premature infants. This program was designed to improve development in preterm children and includes an educational video, tests to evaluate the child's strengths and abilities, and instruction in infant massage.
- Detailed Description
Premature birth is a major cause of developmental delay, and cost-effective, replicable methods to promote development in preterm children are needed. Despite the success of first generation interventions, little is understood about why early intervention does not affect all parents and preterms to the same degree.
This study assessed the efficacy of a three-component intervention (psychoeducational video, serial administrations of the Brazelton Neonatal Behavioral Assessment Scale, and parent-administered infant massage) that targets preterm infants and their mothers and fathers. Outcome measures included infant physical, intellectual, and socioemotional development; parental sensitivity; and infant-parent attachment. The project also assessed the role of parental state of mind regarding attachment and parental commitment to the intervention.
Participants in this study were urban African American mothers and fathers of preterm, low birthweight infants admitted to the neonatal intensive care unit. Fathers were eligible for the study if nominated by the child's mother. Participants were randomly assigned to an intervention group or a control group. Both groups were comparable with respect to race, maternal pregnancy history, education, income, presence/absence of partner, infant gestational age, infant small-for-date status, and infant gender.
The intervention group viewed a videotape about preterm infant abilities. Over the course of the study, the intervention group administered infant massage and completed multiple administrations of the Brazelton Neonatal Behavioral Assessment Scale with increasing parental involvement.
The intervention began when infants were 32 to 36 weeks post-conceptual age (PCA) and ended when infants are 52 to 56 weeks PCA. The efficacy of the intervention and the moderating roles of adult attachment and parental commitment to the intervention were evaluated in terms of infant physical, mental, motor, and social development, and parental adjustment and sensitivity to the infant during the first 2 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 173
- Infants born < 37 weeks gestational age
- Mothers 18 years of age or older
- African American
- Infants with chromosomal abnormalities or other genetic syndromes
- Mothers with positive postpartum toxicology screens
- Infants destined for foster care
Note: age limits for infants refer to post-conceptual age (not actual age)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Anthropometrics (weight, height, head circumference), Bayley Scales of Infant Development, infant behavioral problems and behavioral competencies, maternal sensitivity, infant-parent attachment collected at 4, 12, and 24 months of infant age
- Secondary Outcome Measures
Name Time Method Maternal self-efficacy, parenting stress, perceptions of infant temperament Collected at 4, 12, and 24 months of infant age
Trial Locations
- Locations (5)
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Mercy Medical Center
🇺🇸Baltimore, Maryland, United States
Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
The Pennsylvania State University
🇺🇸University Park, Pennsylvania, United States