Three-Part Program for Parents With Premature Infants

Premature Birth Clinical Trial

Official title:

Adult Attachment and Intervention Efficacy With Preterms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00056680
• Other study ID #: 1R01HD38982-1A6
• Status: Completed
• Phase: N/A
• First received: March 20, 2003
• Last updated: June 19, 2007
• Start date: July 2001
• Est. completion date: December 2006

Study information

• Verified date: May 2007
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 32 Weeks to 37 Weeks

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• Psychoeducational video

• Infant massage

• Brazelton Neonatal Behavioral Assessment Scale

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	The Pennsylvania State University	University Park	Pennsylvania
United States	Children's National Medical Center	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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.

Teti DM, Hess CR, O'Connell M. Parental perceptions of infant vulnerability in a preterm sample: prediction from maternal adaptation to parenthood during the neonatal period. J Dev Behav Pediatr. 2005 Aug;26(4):283-92. — View Citation

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 Con

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maternal self-efficacy, parenting stress, perceptions of infant temperament		Collected at 4, 12, and 24 months of infant age