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Completed

NCT Number: NCT01385254

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

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.

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Key information

Age range

Up to 4 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medical Center, Durham, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    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.

  2. Differences in mother-sibling interaction between two groups

    Time frame: one month and six months

    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.

  3. Differences in internalizing and externalizing behaviors between two groups

    Time frame: one month and six months

    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 outcomes

  1. Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups

    Time frame: one month and six months

    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.

  2. Change in mother-sibling interactions between groups

    Time frame: one month and six months

    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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2011
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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