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Three-Part Program for Parents With Premature Infants

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00056680
First received: March 20, 2003
Last updated: June 19, 2007
Last verified: May 2007

March 20, 2003
June 19, 2007
July 2001
Not Provided
Anthropometrics (weight, height, head circumference), Bayley Scales of Infant Development, infant behavioral problems and behavioral competencies, maternal sensitivity, infant-parent attachment [ Time Frame: collected at 4, 12, and 24 months of infant age ]
Not Provided
Complete list of historical versions of study NCT00056680 on ClinicalTrials.gov Archive Site
Maternal self-efficacy, parenting stress, perceptions of infant temperament [ Time Frame: Collected at 4, 12, and 24 months of infant age ]
Not Provided
Not Provided
Not Provided
 
Three-Part Program for Parents With Premature Infants
Adult Attachment and Intervention Efficacy With Preterms

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Prevention
Premature Birth
  • Behavioral: Psychoeducational video
  • Behavioral: Infant massage
  • Behavioral: Brazelton Neonatal Behavioral Assessment Scale
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
173
December 2006
Not Provided

Inclusion Criteria:

  • Infants born < 37 weeks gestational age
  • Mothers 18 years of age or older
  • African American

Exclusion Criteria:

  • 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)

Both
32 Weeks to 37 Weeks
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00056680
1R01HD38982-1A6
No
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Not Provided
Principal Investigator: Douglas M. Teti, Ph.D. The Pennsylvania State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2007

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