- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01385254
Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
December 10, 2013 updated by: Duke University
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Raleigh, North Carolina, United States, 27610
- Wake Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 4 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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.
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baseline, one month, six months
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Differences in mother-sibling interaction between two groups
Time Frame: one month and six months
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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.
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one month and six months
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Differences in internalizing and externalizing behaviors between two groups
Time Frame: one month and six months
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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.
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one month and six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups
Time Frame: one month and six months
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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.
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one month and six months
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Change in mother-sibling interactions between groups
Time Frame: one month and six months
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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.
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one month and six months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Julie A Thompson, PhD, Duke University School of Nursing
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
January 20, 2011
First Submitted That Met QC Criteria
June 28, 2011
First Posted (Estimate)
June 30, 2011
Study Record Updates
Last Update Posted (Estimate)
December 11, 2013
Last Update Submitted That Met QC Criteria
December 10, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00019788
- 1R03NR011196-01A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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