Clinical Trials Directory

Trials / Completed

CompletedNCT00056680

Three-Part Program for Parents With Premature Infants

Adult Attachment and Intervention Efficacy With Preterms

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
173 (actual)
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
Sex
All
Age
32 Weeks – 37 Weeks
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPsychoeducational video
BEHAVIORALInfant massage
BEHAVIORALBrazelton Neonatal Behavioral Assessment Scale

Timeline

Start date
2001-07-01
Completion
2006-12-01
First posted
2003-03-24
Last updated
2007-06-20

Locations

5 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00056680. Inclusion in this directory is not an endorsement.