NCT00056680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2003

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

June 20, 2007

Status Verified

May 1, 2007

First QC Date

March 20, 2003

Last Update Submit

June 19, 2007

Conditions

Keywords

Prematuritylow birthweightparentingintervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    Collected at 4, 12, and 24 months of infant age

Interventions

Eligibility Criteria

Age32 Weeks - 37 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (3)

  • 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.

  • 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.

    RESULT
  • 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.

    RESULT

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Douglas M. Teti, Ph.D.

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 20, 2003

First Posted

March 24, 2003

Study Start

July 1, 2001

Study Completion

December 1, 2006

Last Updated

June 20, 2007

Record last verified: 2007-05

Locations