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Three-Part Program for Parents With Premature Infants

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducational video
Infant massage
Brazelton Neonatal Behavioral Assessment Scale
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Premature Birth focused on measuring Prematurity, low birthweight, parenting, intervention

Eligibility Criteria

32 Weeks - 37 Weeks (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Children's National Medical Center
  • Washington Hospital Center
  • University of Maryland Medical Center
  • Mercy Medical Center
  • The Pennsylvania State University

Outcomes

Primary Outcome Measures

Anthropometrics (weight, height, head circumference), Bayley Scales of Infant Development, infant behavioral problems and behavioral competencies, maternal sensitivity, infant-parent attachment

Secondary Outcome Measures

Maternal self-efficacy, parenting stress, perceptions of infant temperament

Full Information

First Posted
March 20, 2003
Last Updated
June 19, 2007
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00056680
Brief Title
Three-Part Program for Parents With Premature Infants
Official Title
Adult Attachment and Intervention Efficacy With Preterms
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Prematurity, low birthweight, parenting, intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational video
Intervention Type
Behavioral
Intervention Name(s)
Infant massage
Intervention Type
Behavioral
Intervention Name(s)
Brazelton Neonatal Behavioral Assessment Scale
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Maternal self-efficacy, parenting stress, perceptions of infant temperament
Time Frame
Collected at 4, 12, and 24 months of infant age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
32 Weeks
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas M. Teti, Ph.D.
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Mercy Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
The Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16100501
Citation
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. doi: 10.1097/00004703-200508000-00004.
Results Reference
result
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 Context. New York: Guilford Press.
Results Reference
result
Citation
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.
Results Reference
result

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Three-Part Program for Parents With Premature Infants

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