Viewing Study NCT00056680



Ignite Creation Date: 2024-05-05 @ 11:29 AM
Last Modification Date: 2024-10-26 @ 9:08 AM
Study NCT ID: NCT00056680
Status: COMPLETED
Last Update Posted: 2007-06-20
First Post: 2003-03-20

Brief Title: Three-Part Program for Parents With Premature Infants
Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization: Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD

Study Overview

Official Title: Adult Attachment and Intervention Efficacy With Preterms
Status: COMPLETED
Status Verified Date: 2007-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 childs 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 childs 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 presenceabsence 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None