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Improving Preterm Outcomes by Safeguarding Maternal Mental Health

24 août 2018 mis à jour par: Boston Medical Center
The investigators' goal is to optimize the developmental outcomes of preterm infants by preventing depression and improving functioning among their mothers during the critical first year of life. The investigators are conducting a randomized controlled trial of a replicable, lay-delivered intervention - the basic approach of which is to use an empirically-supported, cognitive behavioral strategy to help mothers solve their unique daily problems and address some of the predictable challenges to parenting a preterm infant.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Preterm infants are born at biological risk for poor health and developmental outcomes; and those born to low-income families face additional social risks known to further interfere with healthy child development. In its 2006 report, Preterm Birth, the Institute of Medicine (IOM) stated the public health importance of optimizing the developmental outcomes of preterm infants, and specifically called for novel postnatal intervention strategies to accomplish this goal. Our proposed strategy is based on the premise that preventing maternal depression - and optimizing maternal functioning in specific domains that mediate the relationship between maternal depression and adverse child effects - will ultimately improve the developmental outcomes of this vulnerable child population.

Problem Solving Education (PSE) is a cognitive behavioral strategy that aims to impart recipients with skills to reduce the impact of stress on personal functioning, and thereby prevent depression. The present project is a randomized trial of a 6-session intervention based on PSE. the investigators aim to enroll 325 mother-infant dyads in four NICUs - Boston Medical Center, Tufts Medical Center, Beth Israel Deaconess Medical Center, and Brigham and Womens Hospital. Over 12-months of follow-up, the investigators will assess the effects of PSE on a series of outcome measures for mothers, a series of measures that represent risk mechanisms by which maternal depression is theorized to impact young children, and a series of child functioning measures.

  1. Primary aims. Regarding outcomes for mothers, the investigators aim to:

    1. Decrease the incidence of major depressive episode (MDE) and improve depressive symptom trajectories during the first postpartum year; and
    2. Improve general and parental functioning, as measured by valid and reliable scales.

  2. Secondary aims. Regarding risk mechanisms and child outcomes, the investigators aim to:

    1. Improve mothers' sense of mastery, and decrease their caregiver burden and social isolation;
    2. Improve adherence to evidence-based quality indicators for NICU follow-up care;
    3. Improve maternal sensitivity and mother-child interaction patterns; and
    4. Improve infant social engagement, emotionality, and cognitive functioning.

  3. Exploratory aims. the investigators will explore the role of a brief set of potential intervention moderators:

    1. On the infant level: severity of infant illness.
    2. On the maternal and family level: maternal trauma history, extended family functioning, and intervention adherence.

Type d'étude

Interventionnel

Inscription (Réel)

325

Phase

  • N'est pas applicable

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

  • États-Unis
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, États-Unis, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, États-Unis, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, États-Unis, 02118
        • Boston 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 60 ans (Enfant, Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Baby is 26-34 weeks gestational age
  • Baby qualifies to receive Medicaid
  • Mother comfortable in English or Spanish
  • Singleton or twin gestation
  • Baby is expected to survive

Exclusion Criteria:

  • Mother in major depressive episode or endorses suicidality
  • Mother with psychosis or otherwise cognitively limited
  • Mother with known active substance use; custody of infant uncertain
  • Infant is critically ill
  • Triplets or higher number gestation
  • Mother who is enrolled in another study receiving the same intervention that we are testing

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

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Problem Solving Education tailored to NICU
NICU-PSE integrates motivational interviewing and problem solving, with ongoing monitoring and linkage to mental health services for mothers with worsening depressive symptoms over time. The intervention is provided over six sessions, including three tailored, post-discharge sessions, which address issues common to families of preterm infants: caregiver burden, complexity of medical follow-up, and social reintegration following hospitalization.
Comportemental: Problem Solving Education tailored to NICU
Aucune intervention: Control
Both study groups receive standard NICU medical, social work, and nursing services. At each study site, attending neonatologists and pediatrics residents constitute the medical team, and all families are assigned a social worker.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of major depressive episode and depressive symptom trajectories
Délai: one year
To measure depression and depressive symptom trajectories, we will combine a dimensional measure (the Quick Inventory of Depressive Symptoms - QIDS) with the diagnostic Structured Clinical Interview for DSM-IV Disorders (SCID). Administering the QIDS every other month during this time frame will allow us to follow depression symptom trajectories with a repeated measure sensitive to change with treatment. Administering the SCID at 12-months will allow us to determine timing and severity of major depressive episode(s).
one year
General Functioning
Délai: one year
General functioning will be measured by the mean total SAS-SR score, and mean scores for the family, partner, and social SAS subscales. The SAS will be administered at 6 and 12 months of follow-up.
one year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Caregiver burden, mastery and social support
Délai: one year
The Coping Health Inventory for Parents is a valid and reliable instrument designed to measure parents' response to managing family life when they have an ill child. It will be administered together with the Pearlin Mastery Scale and the Medical Outcomes Survey Social Support Scale. Administration of these scales will occur at 6 and 12 months of follow-up.
one year
Adherence to recommended NICU follow-up care
Délai: one year

We assess the following measures of adherence to NICU follow-up care:

  • timing and receipt of health supervision visits and immunizations following NICU discharge - including Palivizumab (Synagis).
  • ratio of complaint-based to preventive primary care visits; evaluation for, and attendance to, early intervention services.
one year
Parent-child interaction
Délai: one year
We will videotape and microcode a 10-minute mother-infant free play session according to the parent, infant, and dyadic scales of the Coding Interactive Behavior Manual (CIB). We will assess the following composites: maternal sensitivity; intrusive and withdrawn maternal interactions; and depressed mood and positive affect.
one year
Socio-emotional functioning
Délai: one year
We will assess the CIB infant social engagement composite. We will assess negative infant emotionality using the 4-minute 'Mask Task' of the Laboratory Temperamental Assessment Battery (Lab-TAB).
one year
Cognitive functioning
Délai: one year
We will use the MacArthur-Bates Communicative Development Inventory.
one year

Collaborateurs et enquêteurs

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

Parrainer

Boston Medical Center

Collaborateurs

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Tufts Medical Center

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 juin 2013

Achèvement primaire (Réel)

25 mai 2018

Achèvement de l'étude (Réel)

31 juillet 2018

Dates d'inscription aux études

Première soumission

2 juillet 2013

Première soumission répondant aux critères de contrôle qualité

5 juillet 2013

Première publication (Estimation)

8 juillet 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 août 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 août 2018

Dernière vérification

1 août 2018

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • H-31407
  • R01HD072069 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

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Indécis

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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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