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Three-Part Program for Parents With Premature Infants

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ClinicalTrials.gov Identifier: NCT00056680
Recruitment Status : Completed
First Posted : March 24, 2003
Last Update Posted : June 20, 2007
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Premature Birth Behavioral: Psychoeducational video Behavioral: Infant massage Behavioral: Brazelton Neonatal Behavioral Assessment Scale

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Adult Attachment and Intervention Efficacy With Preterms
Study Start Date : July 2001
Study Completion Date : December 2006
Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Maternal self-efficacy, parenting stress, perceptions of infant temperament [ Time Frame: Collected at 4, 12, and 24 months of infant age ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   32 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056680

United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Mercy Medical Center
Baltimore, Maryland, United States, 21202
United States, Pennsylvania
The Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Douglas M. Teti, Ph.D. The Pennsylvania State University
More Information

Teti, D. M., & Killeen, L. (in press). The role of parental states of mind in effecting parental commitment to an intervention program for premature infants and their parents. In H. Steele & M. Steele (Eds.), The Adult Attachment Interview in Clinical Context. New York: Guilford Press.
Candelaria, MA, O'Connell, MA, & Teti, DM. (2006). Cumulative psychosocial and medical risk as predictors of early infant development and parenting stress in an African-American preterm sample. Journal of Applied Developmental Psychology, 27(6), 588-597.

ClinicalTrials.gov Identifier: NCT00056680     History of Changes
Other Study ID Numbers: 1R01HD38982-1A6
First Posted: March 24, 2003    Key Record Dates
Last Update Posted: June 20, 2007
Last Verified: May 2007

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
low birthweight

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications