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

10 décembre 2013 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

300

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

    • North Carolina
      • Durham, North Carolina, États-Unis, 27710
        • Duke University Medical Center
      • Raleigh, North Carolina, États-Unis, 27610
        • Wake Medical Center

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

Pas plus vieux que 4 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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)

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Differences in level of maternal worry in mothers of very low birthweight (VLBW) infants compared to mothers of full-term infants
Délai: 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.
baseline, one month, six months
Differences in mother-sibling interaction between two groups
Délai: 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.
one month and six months
Differences in internalizing and externalizing behaviors between two groups
Délai: 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.
one month and six months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Effects of maternal worry, anxiety, depression and Post-Traumatic Stress Disorder (PTSD) on two groups
Délai: 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.
one month and six months
Change in mother-sibling interactions between groups
Délai: 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.
one month and six months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Julie A Thompson, PhD, Duke University School of Nursing

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2010

Achèvement primaire (Réel)

1 mai 2012

Achèvement de l'étude (Réel)

1 octobre 2012

Dates d'inscription aux études

Première soumission

20 janvier 2011

Première soumission répondant aux critères de contrôle qualité

28 juin 2011

Première publication (Estimation)

30 juin 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

11 décembre 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 décembre 2013

Dernière vérification

1 décembre 2013

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Pro00019788
  • 1R03NR011196-01A1 (Subvention/contrat des NIH des États-Unis)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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