Improving Preterm Outcomes by Safeguarding Maternal Mental Health

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Boston Medical Center
Sponsor:
Collaborators:
Tufts Medical Center
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Michael Silverstein, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01892982
First received: July 2, 2013
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Depression
Child Development
Behavioral: Problem Solving Education tailored to NICU

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Preterm Outcomes by Safeguarding Maternal Mental Health

Resource links provided by NLM:


Further study details as provided by Boston Medical Center:

Primary Outcome Measures:
  • Incidence of major depressive episode and depressive symptom trajectories [ Time Frame: one year ] [ Designated as safety issue: No ]
    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).

  • General Functioning [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Caregiver burden, mastery and social support [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

  • Adherence to recommended NICU follow-up care [ Time Frame: one year ] [ Designated as safety issue: No ]

    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.

  • Parent-child interaction [ Time Frame: one year ] [ Designated as safety issue: No ]
    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.

  • Socio-emotional functioning [ Time Frame: one year ] [ Designated as safety issue: No ]
    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).

  • Cognitive functioning [ Time Frame: one year ] [ Designated as safety issue: No ]
    We will use the MacArthur-Bates Communicative Development Inventory.


Estimated Enrollment: 325
Study Start Date: June 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Behavioral: Problem Solving Education tailored to NICU
No 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.

Detailed Description:

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01892982

Contacts
Contact: Michael Silverstein, MD, MPH (617) 414-7903

Locations
United States, Massachusetts
Tufts Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Elisabeth Schainker, MD         
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Dmitry Dukhovny, MD, MPH         
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Michael Prendergast, MD         
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Principal Investigator: Michael Silverstein, MD, MPH         
Sub-Investigator: Judith Bernstein         
Sub-Investigator: Howard Cabral, PhD, MPH         
Sub-Investigator: Emily Feinberg, ScD         
Sponsors and Collaborators
Boston Medical Center
Tufts Medical Center
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: Michael Silverstein, Associate Professor of Pediatrics, Boston Medical Center
ClinicalTrials.gov Identifier: NCT01892982     History of Changes
Other Study ID Numbers: R01HD072069
Study First Received: July 2, 2013
Last Updated: March 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Medical Center:
Maternal Depression
Preterm Birth
Preterm Outcomes
Child Development

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 24, 2014