Mother Sibling Interactions Following Very Low Birth Weight (VLBW) Infant Homecoming
10 de dezembro de 2013 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Real)
300
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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North Carolina
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Durham, North Carolina, Estados Unidos, 27710
- Duke University Medical Center
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Raleigh, North Carolina, Estados Unidos, 27610
- Wake Medical Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
Não mais velho que 4 anos (Filho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Mothers who give birth at Duke University Medical Center, Durham Regional Hospital, or Wake Medical Center, and their siblings.
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Julie A Thompson, PhD, Duke University School of Nursing
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2010
Conclusão Primária (Real)
1 de maio de 2012
Conclusão do estudo (Real)
1 de outubro de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
20 de janeiro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de junho de 2011
Primeira postagem (Estimativa)
30 de junho de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
11 de dezembro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
10 de dezembro de 2013
Última verificação
1 de dezembro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Pro00019788
- 1R03NR011196-01A1 (Concessão/Contrato do NIH dos EUA)
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