Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01385254
First received: January 20, 2011
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

The proposed study will explore longitudinally the impact of a very low birthweight (VLBW) infant on mother-sibling interactions and sibling adjustment. The study will also include a comparison group of fullterm infants to determine which sibling adjustment problems are typical of having a new baby in the home and which are associated with the unique stress of having a VLBW infant. This study will be the initial step in identifying factors affecting the adjustment of siblings of VLBW infants.


Condition
Very Low Birthweight

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants [ Time Frame: baseline, one month, six months ] [ Designated as safety issue: No ]
    Explore how the trajectories of maternal worry about the infant and sibling, anxiety, depression, post traumatic stress, concerns for and expectations of the sibling, and perceptions of sibling growth over the 6-month post discharge period differ between mothers of VLBW infants and mothers of fullterms.

  • Differences in mother-sibling interaction between two groups [ Time Frame: one month and six months ] [ Designated as safety issue: No ]
    Explore differences in mother-sibling interactions, including involvement, positive/negative affect, talking, looking and playing, at 1 and 6 months after infant discharge between the two groups of siblings and mothers, using a coding schema to score videotaped interactions.

  • Differences in internalizing and externalizing behaviors between two groups [ Time Frame: one month and six months ] [ Designated as safety issue: No ]
    Explore differences in internalizing and externalizing behaviors, vulnerability, and sleep/somatic problems at 6-months post-infant discharge between siblings of VLBW infants and siblings of fullterms, using a coding schema to score videotaped interactions.


Secondary Outcome Measures:
  • Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups [ Time Frame: one month and six months ] [ Designated as safety issue: No ]
    Examine the effects of maternal worry, anxiety, depression, and post traumatic stress on group differences in mother-sibling interactions at 1 and 6 months after infant discharge.

  • Change in mother-sibling interactions between groups [ Time Frame: one month and six months ] [ Designated as safety issue: No ]
    Examine the effects of changes in mother-sibling interactions from 1 to 6 months after infant discharge on group differences in siblings' internalizing and externalizing behaviors, vulnerability, and sleep/somatic problems.


Enrollment: 300
Study Start Date: January 2010
Study Completion Date: October 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
siblings and mothers of Very Low Birth Weight infants
50 older siblings (closest in age) and mothers of very low birthweight (VLBW) infants, born at <33 weeks gestation and <1500 grams at birth
siblings and mothers of healthy infants
50 siblings (closest in age) and mothers of healthy, full-term infants (between 38-42 weeks gestation and lacking medical conditions that require a hospital stay past the mother's discharge date)

Detailed Description:

The proposed 2-year study will use a longitudinal, comparative, mixed method design to explore the impact of a Very Low Birth Weight (VLBW) (≤33 weeks gestational age) infant on mother-sibling interactions and sibling adjustment. A comparison group of full term infants (≥38 weeks gestational age) will be included to elucidate sibling adjustment problems that are typical to having a new baby in the home and sibling adjustment problems that are associated with the unique stress of having to care for a VLBW infant. Participants will be fifty mothers and siblings of VLBW infants and fifty mothers and siblings of full term infants. Data collection will take place within one week of infant discharge from the hospital (enrollment), and at 1 month and 6 months post infant discharge using self-report measures, qualitative interviews, and mother-sibling interaction observation. Variables of interest include mother's worry, anxiety, depression, and post-traumatic stress; mother-sibling interactions including uninvolvement, positive affect, negative affect, talk, looking and playing; internalizing and externalizing behaviors, sleep/somatic problems, and growth in siblings of VLBW and in siblings of the comparison group with full term infants. Mixed modeling and Ordinary Least Squares (OLS) regression modeling will be conducted to identify factors that make siblings vulnerable to psychological and emotional adjustment problems in response to having a VLBW infant in the home. There are no anticipated risks for the infant participants of the study aside from the small risk of violating confidentiality of infant participants and their mothers. No risks for siblings are anticipated aside from the small risk of violating confidentiality.

  Eligibility

Ages Eligible for Study:   up to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Mothers who give birth at Duke University Medical Center, Durham Regional Hospital, or Wake Medical Center, and their siblings.

Criteria

Inclusion Criteria for siblings:

  • Siblings of very low birth weight or healthy, full-term infants
  • age 4 years old or younger
  • siblings and infants must live with the mother

Inclusion Criteria for mothers:

  • no previous or current diagnosis of major psychological disorder (including bipolar disorder, psychosis, or active substance abuse)
  • age 18 years or older
  • English speaking,
  • living within 1 hour's travel distance from Duke University, for feasibility.
  • Mothers at-risk for preterm birth who meet all other eligibility criteria

Exclusion Criteria:

Mother/sibling pairs of infants who:

  • have congenital neurological problems (congenital hydrocephalus or microcephaly),
  • are symptomatic from substance exposure,
  • are hospitalized longer than 1 month after term, or
  • are technology dependent.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01385254

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wake Medical Center
Raleigh, North Carolina, United States, 27610
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Julie A Thompson, PhD Duke University School of Nursing
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01385254     History of Changes
Other Study ID Numbers: Pro00019788, 1R03NR011196-01A1
Study First Received: January 20, 2011
Last Updated: December 10, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
very low birthweight
premature
sibling adjustment
preterm

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014