Clinical trial NCT01385254: Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
Official title: Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Very Low Birthweight
Keywords: very low birthweight
premature
sibling adjustment
preterm
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2011-06-30
Enrollment: 300
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants
timeFrame: baseline, one month, six months
measure: Differences in mother-sibling interaction between two groups
timeFrame: one month and six months
measure: Differences in internalizing and externalizing behaviors between two groups
timeFrame: one month and six months
Secondary outcomes:
measure: Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups
timeFrame: one month and six months
measure: Change in mother-sibling interactions between groups
timeFrame: one month and six months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Julie A Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References: