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Improving Preterm Outcomes by Safeguarding Maternal Mental Health

24 augustus 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

325

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Verenigde Staten, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, Verenigde Staten, 02118
        • Boston Medical Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

Niet ouder dan 60 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Problem Solving Education tailored to NICU
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of major depressive episode and depressive symptom trajectories
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Caregiver burden, mastery and social support
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: one year
We will use the MacArthur-Bates Communicative Development Inventory.
one year

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Boston Medical Center

Medewerkers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juni 2013

Primaire voltooiing (Werkelijk)

25 mei 2018

Studie voltooiing (Werkelijk)

31 juli 2018

Studieregistratiedata

Eerst ingediend

2 juli 2013

Eerst ingediend dat voldeed aan de QC-criteria

5 juli 2013

Eerst geplaatst (Schatting)

8 juli 2013

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2018

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2018

Laatst geverifieerd

1 augustus 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • H-31407
  • R01HD072069 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Onbeslist

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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